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{\author Heran Kim}{\operator Computing Services}{\creatim\yr2006\mo6\dy7\hr10\min42}{\revtim\yr2006\mo6\dy7\hr10\min42}{\printim\yr2006\mo5\dy5\hr12\min22}{\version2}{\edmins0}{\nofpages29}{\nofwords14050}{\nofchars80086}{\*\company Covington & Burling}
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\par Reimportation of Prescription Drugs \endash  Legislative, Excutive Judicial and State &Local Responses
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\par }\pard \qr \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\b\caps\f36\insrsid157761\charrsid11742280 
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\par }{\b\f36\insrsid157761\charrsid11742280 Lauren Kim
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\par Class of 2006
\par April 2006
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\par }{\f358\insrsid157761 This paper is submitted in satisfaction of the course requirement for Food & Drug Law with Professor Peter Hutt and the third year written work requirement.\sect }\sectd \linex0\endnhere\sectdefaultcl\sectrsid157761\sftnbj {\header 
\pard\plain \s26\ql \li0\ri0\widctlpar\tqc\tx4320\tqr\tx8640\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid157761 
\par }}{\footer \pard\plain \s27\qc \li0\ri0\widctlpar\tqc\tx4320\tqr\tx8640\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\field{\*\fldinst {\cs28\insrsid157761  PAGE }}{\fldrslt {
\cs28\lang1024\langfe1024\noproof\insrsid14445945 28}}}{\cs28\lang1024\langfe1024\noproof\insrsid157761  of }{\field{\*\fldinst {\cs28\insrsid157761   NUMPAGES}}{\fldrslt {\cs28\lang1024\langfe1024\noproof\insrsid157761 66}}}{
\cs28\lang1024\langfe1024\noproof\insrsid157761  }}\pard\plain \qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\b\caps\f36\insrsid157761\charrsid11742280 

\par 
\par }{\caps\f36\insrsid157761\charrsid11742280 
\par }\pard \qj \li1080\ri936\widctlpar\aspalpha\aspnum\faauto\adjustright\rin936\lin1080\itap0\pararsid157761 {\b\i\f36\insrsid157761\charrsid13313819 Abstract: }{\i\f36\insrsid157761\charrsid13313819 
The expensive cost of prescription drugs has become a high-profile issue in the United States, challenging the government and policy-makers to create a solution that addr
esses all the factors involved in this issue. Creating a solution is not an easy task, as the factors are all important and valid, ranging from quality and safety, the need for innovative new prescription drugs, and individual access to necessary medicati
o
ns.  Many individuals and entities view the reimportation of prescription drugs as the solution to this problem, despite its current illegality.  As a result, these individuals and entities have not only challenged its current illegality but have actually
 
engaged in the illegal behavior.  This, combined with the need to deal with the problem of exorbitant prescription drug prices, has prompted responses by all branches of the government, from the legislature, to the executive through administrative agencie
s
, and even to the judiciary.  Additionally, individual states have also responded, though not all uniformly.  This paper tracks the statutory history of reimportation and examines the responses these entities have recently taken with regard to reimportati
on.  
\par }\pard \qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\caps\f36\insrsid157761\charrsid13313819 
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\f36\insrsid157761\charrsid2900592 
\par }{\b\scaps\f36\insrsid157761\charrsid7996244 Introduction
\par }{\b\f36\insrsid157761\charrsid2900592 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761 
The last decade has been filled with numerous media stories about the sick and elderly either having to forego the necessity of food or splitting pills in order to pay for their high-priced prescription drugs.  While there are indeed m
any individuals engaging in such desperate acts in order to access much needed prescription drugs, others are turning to alternative means of accessing these pharmaceuticals.  American consumers have realized that prescription drugs are significantly chea
p
er in other countries, primarily because these countries exert some form of price control on pharmaceuticals.   As a result, more and more Americans are either importing or reimporting prescriptions drugs from other countries.  Unfortunately this increasi
n
g trend is seen as troubling by many entities, including the federal government, which is primarily concerned with the safety and quality of these drugs as well as with the effect this trend will have on the development of innovative new drugs if pharmace
u
tical companies no longer have an incentive to invest in research and development.  The topic of reimportation has become such an important issue that it has elicited responses from all branches of the government (legislative, executive, and judicial) as 
w
ell as from individual states.  For example, (1) the past couple years have produced a plethora of bills attempting to reach a compromise between those who support reimportation as a means of access to affordable pharmaceuticals and those who oppose it fo
r
 either safety or reduced investment in research and development concerns; (2) the Department of Justice has brought suit against those who are illegally reimporting prescription drugs; (3) courts have been trying these cases; and (4) individual states ha
ve implemented reimportation programs for their citizens. }{\insrsid157761\charrsid15956527   }{\insrsid157761 
Each of the stances that these entities have taken on the reimportation issue can certainly be considered a valid stance, as there are justified reasons for taking a particular side.  This is essen
tially what makes this such a contentious debate and one in which a compromise is difficult to find. }{\f36\insrsid157761\charrsid7996244 
This paper tracks the statutory history of reimportation and examines the responses these entities have recently taken with regard to reimportation.}{\i\f36\insrsid157761\charrsid13313819   
\par }\pard \qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\caps\f36\insrsid157761\charrsid13313819 
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid2900592 
\par }{\b\scaps\insrsid157761\charrsid7996244 Legislative Response
\par }{\b\insrsid157761\charrsid11742280 
\par I.  Statutory Background of the Reimportation of Prescription Drugs
\par }{\insrsid157761\charrsid2900592 
\par }{\b\i\insrsid157761\charrsid11742280 \tab A.  Origins of Drug Regulation
\par 
\par }\pard \ql \li0\ri0\sl480\slmult1\nowidctlpar\tx560\tx1120\tx1680\tx2240\tx2800\tx3360\tx3920\tx4480\tx5040\tx5600\tx6160\tx6720\faauto\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid2900592 \tab 
Any inquiry into the history of the regulation of reimportation of prescription drugs in the United States must begin with a history 
of the regulation of prescription drugs in general. The nineteenth century was devoid of any regulation of the sale of drugs in the U.S. and it was not until the passage of the Federal Food and Drug Act of 1906 that drugs began to be regulated.}{
\cs16\super\insrsid157761\charrsid2900592 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\scaps\fs22\super\insrsid157761\charrsid15610012 \chftn }{\scaps\fs22\insrsid157761\charrsid15610012  James Nielson, Handbook of Federal Drug Law}{\fs22\insrsid157761\charrsid15610012  4 (1992).}}}{\insrsid157761\charrsid2900592   This legi
slation was passed in response to inflamed public opinion regarding not only fraudulent curative claims but also drugs containing varying degrees of harmful ingredients.}{\cs16\super\insrsid157761\charrsid2900592 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  James F. Hoge, }{
\i\fs22\insrsid157761\charrsid1665427 Drug Law in Historical Perspective}{\fs22\insrsid157761\charrsid15610012 , }{\fs22\cf1\insrsid157761\charrsid1665427 1 }{\scaps\fs22\cf1\insrsid157761\charrsid1665427 Food Drug Cosm. L.Q. 50, }{
\fs22\cf1\insrsid157761\charrsid1665427 50-51 (1946).}}}{\insrsid157761\charrsid2900592   For example, in one case, soothing syrups for babies and young children contained cocaine and morphine.}{\cs16\super\insrsid157761\charrsid2900592 \chftn {\footnote 
\pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\fs22\cf1\insrsid157761\charrsid1665427 Watson B. Miller, }{\i\fs22\cf1\insrsid157761\charrsid1665427 Introduction to the Act}{\fs22\cf1\insrsid157761\charrsid1665427 , 1 }{\scaps\fs22\cf1\insrsid157761\charrsid1665427 Food Drug Cosm}{
\fs22\cf1\insrsid157761\charrsid1665427 . L.Q. 50, 292 (1946).}}}{\insrsid157761\charrsid2900592   This public outrage was further exacerbated by Upton Sinclair\rquote s novel, }{\i\insrsid157761\charrsid2900592 The Jungle, }{
\insrsid157761\charrsid2900592 which portrayed the unsanitary packing conditions in Chicago packing plants.}{\cs16\super\insrsid157761\charrsid2900592 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\fs22\insrsid157761\charrsid1665427 Hoge, }{\i\fs22\insrsid157761\charrsid1665427 supra}{\fs22\insrsid157761\charrsid1665427  note 2, at 50.}{\f360\fs22\cf1\insrsid157761\charrsid15610012  }}}{\insrsid157761\charrsid2900592 
  This legislation, however, was not very robust.  It attempted to ensure that drugs were safe and effective by merely prohibiting adulterated and misbranded drugs from interstate commerce.}{\cs16\super\insrsid157761\charrsid2900592 \chftn {\footnote 
\pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\scaps\fs22\insrsid157761\charrsid15610012 N}{\fs22\insrsid157761\charrsid15610012 ielson, }{\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012  note 1.}}}{\insrsid157761\charrsid2900592 
  It was not until the Sulfanilamide disaster of 1937, killing seventy-three people, many of whom were children, that Congress passed more stringent regulations to ensure the safety of drugs.}{\cs16\super\insrsid157761\charrsid2900592 \chftn {\footnote 
\pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 See }{\scaps\fs22\insrsid157761\charrsid15610012 Henry G. Grabowski & John M. Vernon, The Regulation of Pharmaceuticals: Balancing the Benefits and Risks}{\fs22\insrsid157761\charrsid15610012  2 (1983).}}}{
\insrsid157761\charrsid2900592    This }{\insrsid157761\charrsid1665427 disaster was the result of a drug company marketing an untested drug composed of a solvent that was a highly toxic chemical analogue to antifreeze.}{
\cs16\super\insrsid157761\charrsid1665427 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid157761 \chftn }{
\insrsid157761  }{\fs22\insrsid157761\charrsid1665427 History of the FDA \endash  The 1938 Food, Drug, and Cosmetic Act, http://www.fda.gov/oc/history/historyoffda/section2.html }}}{\insrsid157761\charrsid1665427   }{\insrsid157761\charrsid1665427 
The public outcry that ensured not only shaped the drug provisions of the new law to prevent such an event from happening again, it propelled the Federal Food, Drug and Cosmetic Act of 1938 (\'93FDCA\'94) through Congress.}{
\cs16\super\insrsid157761\charrsid1665427 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid157761 \chftn }{
\insrsid157761  }{\i\insrsid157761 Id.; }{\i\fs22\insrsid157761\charrsid1665427 ch.}{\fs22\insrsid157761\charrsid1665427 675, \'a7 505, 52 Stat. 1052.}}}{\insrsid157761\charrsid1665427   Unlike the Federal Food and Drug Act, which only}{
\insrsid157761\charrsid2900592  gave the Bureau of Chemistry the a
uthority to intervene against the sale of misbranded or adulterated drugs in interstate commerce, the provisions of the FDCA provided consumer safety by regulating earlier on in the process of drug sales.  While still maintaining the prohibition on the sa
le of misbranded or adulterated drugs, drug manufacturers now had to go one step further and prove that their drugs were safe by submitting a new drug application (\'93NDA\'94) to the Food and Drug Administration (\'93FDA\'94
) before introducing any new drug into interstate commerce.}{\cs16\super\insrsid157761\charrsid2900592 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid157761 \chftn }{\insrsid157761  }{\scaps\fs22\insrsid157761\charrsid15610012 Grabowski & Vernon}{\fs22\insrsid157761\charrsid15610012 , }{\i\fs22\insrsid157761\charrsid15610012 
supra}{\fs22\insrsid157761\charrsid15610012  note 6.}}}{\insrsid157761\charrsid2900592  The NDA is just one aspect of the \'93closed system\'94 that has been created to protect the nation\rquote s drug supply.}{\cs16\super\insrsid157761\charrsid2900592 
\chftn {\footnote \pard\plain \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{
\i\scaps\fs22\insrsid157761\charrsid15610012 I}{\i\fs22\insrsid157761\charrsid15610012 d}{\fs22\insrsid157761\charrsid15610012 ; }{\fs22\insrsid157761\charrsid1665427 The requirement of an NDA essentially created a closed drug distribution system. }{
\fs22\cf1\insrsid157761\charrsid1665427 This closed system ensures limited channels of entry into the U.S. drug supply system. This system evolved as a result of legislative requirements that
 drugs be treated as potentially dangerous consumer goods that require professional oversight to protect the public health.}{\fs22\insrsid157761\charrsid1665427  }{\scaps\fs22\insrsid157761\charrsid1665427 
Task Force, Report on Prescription Drug Importation}{\fs22\insrsid157761\charrsid15610012  xii, Dec. 2004, }{\i\fs22\insrsid157761\charrsid1665427 at}{\fs22\insrsid157761\charrsid15610012  }{\fs22\insrsid157761\charrsid1665427 
http://www.hhs.gov/importtaskforce/Report1220.pdf}{\fs22\insrsid157761\charrsid15610012  [hereinafter \'93Task Force Report].}{\fs22\insrsid157761\charrsid1665427  }{\fs22\cf1\insrsid157761\charrsid1665427 
Although the original purpose behind designing this closed system was to ensure the safety and quality of the U.S. drug supply, it currently serves two additional unintended purposes as well \endash  (1) it protects pharmaceutical companies\rquote 
 profits by preventing foreign-imposed}{\cf1\insrsid157761\charrsid2057514  }{\fs22\cf1\insrsid157761\charrsid1665427 
price controls to also be imported into the U.S. and (2) protects their profits by preventing comparable drugs manufactured by foreign companies from competing against a U.S. developed drug.  As will be mentioned in 
further detail below, practically all the industrialized countries have some form of prescription drug price controls in place that make it difficult for pharmaceutical companies to charge high prices.}{\f360\fs22\cf1\insrsid157761   }{
\fs22\cf1\insrsid157761 D}{\fs22\insrsid157761\charrsid15610012 aniel R. Cahoy, }{\i\fs22\insrsid157761\charrsid15610012 Patent Fences and Constitutional Fence Posts: Property Barriers to Pharmaceutical Importation}{\fs22\insrsid157761\charrsid15610012 
, 15 }{\scaps\fs22\insrsid157761\charrsid15610012 Fordham Intell. Prop. Media & Ent. L.J}{\fs22\insrsid157761\charrsid15610012 . 623, 637 (2005). }{\fs22\cf1\insrsid157761\charrsid1665427  Because of this, pharmaceutical companies\rquote 
 hands are tied and they have no choice but to charge lower prices.  If Americans are permitte
d to merely buy the same drugs abroad at lower prices, the U.S. is effectively allowing the importation of foreign price controls and as a result the profitability of pharmaceutical research and development investments will fall.}{\fs22\cf1\insrsid157761 
  J}{\fs22\insrsid157761\charrsid15610012 oseph H. Golec & John A. Vernon, }{\i\fs22\insrsid157761\charrsid15610012 What\rquote s at Stake in Pharmaceutical Reimportation: The Costs in Terms of Life Years, Lives and Dollars, }{
\scaps\fs22\insrsid157761\charrsid15610012 16 J. Law & Pub. Pol\rquote y 135, 135-36 (2005).}{\fs22\cf1\insrsid157761\charrsid1665427  This will have a detrimental future affect for Americans citizens, as pharmaceutical companies will de
velop fewer and fewer innovative new drugs that may be essential for future health.  Although many individuals claim that pharmaceutical companies\rquote 
 profits are currently too high, the reality is that expected profitability is the primary determinant of a pharmaceutical companies\rquote  investment in developing new drugs.}{\fs22\cf1\insrsid157761   }{\i\fs22\cf1\insrsid157761 See }{
\fs22\insrsid157761\charrsid15610012 Henry G. Grabowski & John M. Vernon, }{\i\fs22\insrsid157761\charrsid15610012 The Determinants of Pharmaceutical Research and Development Expenditures}{\fs22\insrsid157761\charrsid15610012 , 10 }{
\scaps\fs22\insrsid157761\charrsid15610012 J. Evolutionary Econ}{\i\scaps\fs22\insrsid157761\charrsid15610012 . }{\scaps\fs22\insrsid157761\charrsid15610012 201, 201-02 (2000).}{\fs22\cf1\insrsid157761\charrsid1665427  Moreover, pharmaceutical companies
 counter these claims by arguing that their high profits are the reason behind the U.S. having the \'93best, most innovative health care system in the world.\'94}{\cs16\fs22\cf1\super\insrsid157761\charrsid1665427  }{\fs22\insrsid157761\charrsid1665427 
PhRMA - Publications, http://phrma.org/publications/publications/brochure/questions/canadacontrols.cfm. }{\fs22\cf1\insrsid157761\charrsid1665427  Additionally, proponents of pharmaceutical companies ask, \'93
Considering all the money and time involved in creating a new drug, why would any company invest that time and money if it couldn\rquote t keep the profits?\'94}{\fs22\cf1\insrsid157761  }{\i\fs22\insrsid157761\charrsid15610012 See }{
\fs22\insrsid157761\charrsid15610012 Kevin Hassett, }{\i\fs22\insrsid157761\charrsid15610012 The Misguided Assault on the U.S. Drug Industry}{\fs22\insrsid157761\charrsid15610012 , }{\i\fs22\insrsid157761\charrsid1665427 available at}{
\fs22\insrsid157761\charrsid15610012  }{\fs22\insrsid157761\charrsid1665427 http://quote.bloomberg.com/apps/news?pid=10000039&refer=columnist_hassett&sid=agyGgn3MYGDg}{\fs22\insrsid157761\charrsid15610012 .  }{\fs22\cf1\insrsid157761\charrsid1665427 
 Thus the current closed system provides assurance to pharmaceutical companies that they will continue to make enough of a profit to invest in R&D which ensures that U.S. citizens will continue to enjoy the benefits of innovation.  
\par }\pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs22\insrsid157761\charrsid1665427 \tab 
The Tufts Center for the Study of Drug Development suggests that each newly invented drug has over $800 million in research and development costs to recoup before it is technically profitable.}{\f360\fs22\insrsid157761\charrsid1665427  }{
\i\fs22\insrsid157761\charrsid1665427 Id.}{\fs22\insrsid157761\charrsid1665427 
 at 635. Thus not only must a pharmaceutical company recoup these costs through profits, it must also recoup the costs of failed drug discoveries as well.  Permitting U.S. consumers to import foreign-versi
ons of prescription drugs increases competition for pharmaceutical companies and thereby increases the risk that these companies may not recoup all their costs.  This creates disincentives for these companies to invest their limited profits into research 
a
nd development, which results in the same consequences mentioned above.  Thus the current closed system performs two functions, it ensures the safety and quality of prescription drugs consumed by U.S. citizens as well as assuring these same citizens the l
uxury of innovative new drugs by protecting the pharmaceutical companies\rquote  investments into R&D.}}}{\insrsid157761\charrsid2900592   A CRS Report for Congress provides an accurate description of the closed system. }{
\f36\insrsid157761\charrsid10628549 
\par }\pard \qj \li720\ri1440\nowidctlpar\tx560\tx1120\tx1680\tx2240\tx2800\tx3360\tx3920\tx4480\tx5040\tx5600\tx6160\tx6720\faauto\rin1440\lin720\itap0\pararsid157761 {\f36\insrsid157761\charrsid10628549 
\par Before it approves a prescription drug for sale, FDA requires that a 
\par manufacturer demonstrate that its product is safe and effective for its intended use, that directions on the label are clear and appropriate, and that the drug has been manufactured in specific production lines that have been regis
tered and approved by FDA.  After approval, the manufacturer must continue production according to FDA- approved \'d2good manufacturing processes.\'d3
 The drug company must periodically open their production facilities to rigorous FDA inspection. After productio
n, the manufacturer sends the drug to FDA-registered U.S. drug wholesalers or secondary drug wholesalers for further distribution.  States license or authorize the pharmacists and wholesalers who sell and distribute pharmaceuticals 
\par within their borders and also license the physicians and dentists who prescribe the drugs.}{\cs16\f36\super\insrsid157761\charrsid10628549 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid157761 \chftn }{\insrsid157761  Susan Thaul & Donna U. Vogt, }{\i\fs22\insrsid157761\charrsid15610012 Importing Prescription Drugs: Objectives, Optoins and Outlook}{
\fs22\insrsid157761\charrsid15610012 , CRS Report for Congress, CRS-3, Aug. 4, 2004.}}}{\f4\insrsid157761\charrsid10628549 
\par }{\insrsid157761\charrsid2057514 
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid2057514 
\par }\pard \ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\b\insrsid157761\charrsid2900592 B.  The Emergence of Reimportation Legislation}{\b\insrsid157761\charrsid11742280 
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid2900592 \tab 
\par }\pard \qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\b\insrsid157761\charrsid11742280 Prescription Drug Marketing Act of 1987 and Prescription Drug Amendments of 1992
\par 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid2900592 \tab The Federal Food & Drug Act of 1906  and the FDCA wer
e passed to ensure that pharmaceuticals were healthy and safe for consumers but did not contain any provisions regarding the reimportation of prescription drugs.  This is due to the fact that this had not been an issue at the time these acts were passed. 
 
However, in the 1980s, prescription drug diversion began to become a problem, highlighted by two widely-publicized cases.  In 1984, over one million counterfeit birth control pills were shipped to Miami and New York from Panama and distributed through leg
itimate channels.}{\cs16\super\insrsid157761\charrsid2900592 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid157761 
\chftn }{\insrsid157761  }{\fs22\insrsid157761\charrsid15610012 99th }{\scaps\fs22\insrsid157761\charrsid1665427 Cong}{\fs22\insrsid157761\charrsid15610012 ., 2nd }{\scaps\fs22\insrsid157761\charrsid1665427 Sess.}{\i\fs22\insrsid157761\charrsid15610012  }
{\scaps\fs22\insrsid157761\charrsid1665427 Dangerous Medicine: The Risk to American Consumers From Prescription Drug Diversion and Counterfeiting}{\fs22\insrsid157761\charrsid15610012 , 22 (Comm. Print 1986).\~}}}{\insrsid157761\charrsid2900592 
   The counterfeit pills, indistinguishable in appearance from the real pills, were completely ineffective.}{\cs16\super\insrsid157761\charrsid2900592 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid157761 \chftn }{\insrsid157761  }{\i\insrsid157761 Id. }}}{\insrsid157761\charrsid2900592 
  This put women, who specifically took the pills to prevent pregnancy, at the risk of becoming pregnant.  The following year, 1800 bottles of counterfeit, antibiotic capsules entered the U.S. through Miami and Boston from Singapore.}{
\cs16\super\insrsid157761\charrsid2900592 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid157761 \chftn }{
\insrsid157761  }{\i\insrsid157761 Id. }}}{\insrsid157761\charrsid2900592   These drugs, while containing the manufacturer\rquote s active ingredient, had fake capsules, lot numbers and packaging.}{\cs16\super\insrsid157761\charrsid2900592 \chftn 
{\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id. }}}{\insrsid157761\charrsid2900592    Congress recognized that the count
ry was facing the problem of prescription drug diversion, which was putting the health and safety of American citizens at risk.  The Subcommittee of Oversight and Investigations of the Committee on Energy and Commerce succinctly stated the problem in a re
port. 
\par }\pard \qj \li720\ri1440\widctlpar\aspalpha\aspnum\faauto\adjustright\rin1440\lin720\itap0\pararsid157761 {\insrsid157761\charrsid2900592 \tab 
A significant volume of pharmaceuticals are being reimported to the United States as American Goods Returned.  These goods present a health and safety risk to American consumers because they may have become subpotent or adulterated during foreign sh
ipping and handling.  The ready market for reimports has also been a catalyst for the perpetration of the continuing series of frauds against American manufacturers, and has provided the cover for the importation of counterfeit pharmaceuticals in at least
 two cases.}{\cs16\super\insrsid157761\charrsid2900592 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id. }}}{\insrsid157761\charrsid2900592   
\par }\pard \qj \li720\ri720\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid157761 {\insrsid157761\charrsid2900592 
\par }\pard \ql \fi630\li90\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin90\itap0\pararsid157761 {\insrsid157761\charrsid2900592 
Senator John D. Dingell, chair of the Committee holding the Congressional Oversight hearings on this problem described other factors that created the dangers associated with reimportation.
\par }\pard \qj \li720\ri1440\widctlpar\aspalpha\aspnum\faauto\adjustright\rin1440\lin720\itap0\pararsid157761 {\insrsid157761\charrsid2900592 It is important to note that even legitimate pharmaceuticals marked \'93American goods returned\'94
 pose significant health and safety problems to American consumers.  The export and reimport process contains inherent dangers, including lack of proper storage and handling controls.  Drugs destined for foreign mar
kets may be labeled differently than those designed for sale in our market.  Thus, these prescription drugs may be expired, mislabeled or damaged from excessive heat, cold or moisture.  There is simply no assurance that they are safe.}{
\cs16\super\insrsid157761\charrsid2900592 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 
\chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Prescription Drug Diversion and Counterfeiting}{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 \endash  Part I}{
\fs22\insrsid157761\charrsid15610012 : Hearings before the Subcomm. on Oversight and Investigations of the Comm. on Energy and Commerce, 99th Cong. 37 (1985) (statement of Hon. John D. Dingell).}}}{\insrsid157761\charrsid2900592  
\par }\pard \ql \li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0\pararsid157761 {\insrsid157761\charrsid2900592 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid2900592 These Congressiona
l oversight hearings made it apparent that the current laws of the United States could not assure that reimported pharmaceutical drugs had been properly handled, stored and labeled and thus could not ensure their safety or quality.  
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid2900592 In acknowledgement of 
these risks to consumers, Congress adopted the recommendation of the subcommittee report that reimportation of pharmaceuticals be banned and passed the Prescription Drug Marketing Act of 1987 and later the Prescription Drug Amendments of 1992.}{
\cs16\super\insrsid157761\charrsid2900592 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 
\chftn }{\fs22\insrsid157761\charrsid15610012  Benjamin A. Drabiak, Note, }{\i\fs22\insrsid157761\charrsid15610012 Reimportation of Prescription Drugs: Long-Lasting Relief or a Short-Term Analgesic? }{\fs22\insrsid157761\charrsid15610012 
4 Wash. U. Global Stud. L. Rev. 135, 140 (2005).}}}{\insrsid157761\charrsid2900592  These two a
cts of Congress amended the FDCA to prohibit prescription drug reimportation except by the U.S. manufacturer of the drug or if the Secretary of Health and Human Services (\'93HHS\'94) decides that the drug is required for emergency medical care.}{
\cs16\super\insrsid157761\charrsid2900592 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 
\chftn }{\fs22\insrsid157761\charrsid15610012  Pub.L. No. 100-293, 102 Stat. 95 (1987) (codified at 21 U.S.C. 301, 331(t), 333(v), 353(c)-(e), 381).}}}{\insrsid157761\charrsid2900592   
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid2900592 \tab 
\par }\pard \qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\b\insrsid157761\charrsid11742280 Medicine Equity and Drug Safety Act
\par 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid2900592 \tab 
In the 1980s the impetus behind banning reimportation was the desire to prevent unscrupulous merchants from placing American citizens in danger by selling them counterfeit prescription drugs, which may have made it relatively eas
y to prohibit reimportation without much opposition.  However, circumstances have changed in the last few decades such that the reimportation as been transformed from a mere topic into a contentious debate.  Although the underlying rationale for banning i
mportation is still the same \endash  consumer protection, the current exorbitant prices of prescription drugs have many consumers asking for a repeal of the reimportation ban. Congress recognized this growing debate, finding that: 
\par }\pard \qj \li1080\ri1440\widctlpar\aspalpha\aspnum\faauto\adjustright\rin1440\lin1080\itap0\pararsid157761 {\insrsid157761\charrsid2900592  (1) The cost of prescription drugs for Americans continues to rise at an alarming rate.
\par (2) Millions of Americans, including Medicare beneficiaries on fixed incomes, face a daily choice between purchasing life-sustaining prescription drugs, or paying for other necessities, such as food and housing. 
\par (3) Many life-saving prescription drugs are found in countries other than the United States at substantially lower prices, even though such drugs are developed and approved for use by patients in the United States. 
\par (4) Many Americans travel to other countries to purchase prescription drugs because the medicines that they need are unaffordable in the United States; 
\par (5) Americans should be able to purchase medicines that are comparable to prices for medicines in other countries, but efforts t
o enable such purchases should not endanger the gold standard for safety and effectiveness that has been established and maintained in the United States.}{\cs16\super\insrsid157761\charrsid2900592 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\scaps\fs22\super\insrsid157761\charrsid1665427 \chftn }{\scaps\fs22\insrsid157761\charrsid1665427 
 H.R. Rep. No. 106-948, }{\fs22\insrsid157761\charrsid1665427 at }{\scaps\fs22\insrsid157761\charrsid1665427 39 (2000).}{\scaps\fs22\insrsid157761\charrsid15610012  }}}{\insrsid157761\charrsid2900592   
\par }\pard \qj \li1080\ri1440\widctlpar\aspalpha\aspnum\faauto\adjustright\rin1440\lin1080\itap0\pararsid157761 {\insrsid157761\charrsid2900592 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid2900592 \tab As a result of these findings, in 2000 Congress passed, and former President Bill Clinton signed 
into law, the Medicine Equity and Drug Safety Act (\'93MEDSA\'94) which repealed the provision that allowed only manufacturers to reimport pharmaceuticals and instead included what has been called a \'93reimportation plan.\'94}{
\cs16\super\insrsid157761\charrsid2900592 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 
\chftn }{\fs22\insrsid157761\charrsid15610012  Chad Silker, Note, }{\i\fs22\insrsid157761\charrsid1665427 America\rquote s New War on Drugs: Should the United States Legalize Prescription Drug Reimportation?}{\fs22\insrsid157761\charrsid15610012 
, 31 J. Legis. 379, 384 (2005) (citing Medicine Equity and Drug Safety Act of 2000, 21 U.S.C. 384 (2000)). }}}{\insrsid157761\charrsid2900592   MEDSA allows commercial importers (phar
macists or wholesalers) to import American-made, FDA-approved pharmaceuticals from foreign markets into the U.S.}{\cs16\super\insrsid157761\charrsid2900592 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id}{\fs22\insrsid157761\charrsid15610012 .}}}{\insrsid157761\charrsid2900592 
  American consumers can then buy these drugs at lower prices because these importers then sell the reimported drugs at prices lower than those available in the U.S.}{\cs16\super\insrsid157761\charrsid2900592 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012  (citing A. Bryan Baer, Note, }{\i\fs22\insrsid157761\charrsid1665427 Price Controls Through the Back Door: The Parallel Importation of Pharmaceuticals}{
\fs22\insrsid157761\charrsid15610012 , 9 }{\scaps\fs22\insrsid157761\charrsid1665427 J. Intell. Prop. L}{\fs22\insrsid157761\charrsid15610012 . 109, 109-10 (2001)). }}}{\insrsid157761\charrsid2900592 
  MEDSA appears to recognize consumer disregard for the illegality of reimportation in the midst of high pharmaceutical prices and attempts to reach a compromise position by allowing only some kinds of reimportation, specifically, re
importation of drugs that have adhered to required safeguards ensuring that the imported products are approved, safe and effective for their intended uses. These required safeguards include detailed labeling, records maintenance, and testing requirements 
for importers.}{\cs16\super\insrsid157761\charrsid2900592 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Medicine Equity and Drug Safety Act of 2000, 21 U.S.C. 384 (2000)}}}{\insrsid157761\charrsid2900592 
   For example, among other things, importers must (1) include the amounts of active ingredients and a description of the dosage form, (2) report the quantity, date, points of origin and destination of the product, (3) include documentation s
pecifying the original source of the product and professional license number of the importer, (4) certify that the product is approved for marketing in the United States and meets all labeling requirements of the FDCA, and (5) perform tests that demonstra
te that the product is authentic.}{\cs16\super\insrsid157761\charrsid2900592 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id.}}}{\insrsid157761\charrsid2900592 
  Additionally, allowing reimportation from only designated countries is another provision designed to ensure safety.}{\cs16\super\insrsid157761\charrsid2900592 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.}}}{\insrsid157761\charrsid2900592   However, although MEDSA was signed into law, it has never been implemented.}{\cs16\super\insrsid157761\charrsid2900592 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Silker, }{
\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012  note 21, at 384 (citing Congressman Gil Gutknecht, Prescription Drugs }{\i\fs22\insrsid157761\charrsid1665427 at }{\fs22\insrsid157761\charrsid15610012 
www.gil.house.gov/Issues/PDrugs/pdrugssummary.htm (last visited Oct. 26, 2003)(on file with author)).}}}{\insrsid157761\charrsid2900592   The reimportation plan may only be put into effect after one requirement is met \endash 
 certification by the Secretary of HHS.  In order for MEDSA to be implemented, the reimportation provision of MEDSA requires the Secretary of HHS to certify to Congress that the imported drugs do not 
pose a risk to health and safety and that it will significantly reduce the costs of covered products to the American consumer.}{\cs16\super\insrsid157761\charrsid2900592 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  21 U.S.C. 384 (2006). }}}
{\insrsid157761\charrsid2900592   Since the passage of MEDSA, neither of the Secretaries of HHS (Donna Shalala in the Clinton Administration and Tommy Thompson i
n the George W. Bush Administration) has implemented the provision by agreeing to the required certification.}{\cs16\super\insrsid157761\charrsid2900592 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 See }{\fs22\insrsid157761\charrsid15610012 Silker, }{\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012  note 21, at 384.}}}{\insrsid157761\charrsid2900592 
  Donna Shalala, in a letter to President Clinton, wrote that \'93[f]laws and loopholes contained in the reimportation provision make it impossible for me to demonstrate that it is safe and cost-effective.\'94}{\cs16\super\insrsid157761\charrsid2900592 
\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{
\fs22\insrsid157761\charrsid15610012  Marc Kaufman, }{\i\fs22\insrsid157761\charrsid1665427 Shalala Halts Bid to Lower Drug Costs}{\fs22\insrsid157761\charrsid15610012 , }{\scaps\fs22\insrsid157761\charrsid1665427 Wash. Post}{
\fs22\insrsid157761\charrsid15610012 , Dec. 27, 2000, at }{\fs22\cf1\insrsid157761\charrsid15610012 A1.  }}}{\insrsid157761\charrsid2900592   Subsequently, when Tommy Thompson became Secretary of HHS, he was asked to reconsider former Donna Shalala
\rquote s decision and to make the safety and cost determination necessary to implement MEDSA.}{\cs16\super\insrsid157761\charrsid2900592 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Letter from Tommy Thompson, Secretary, 
Department of Health and Human Services, to the Honorable James Jeffords, United States Senate (July 9, 2001), }{\i\fs22\insrsid157761\charrsid1665427 at}{\fs22\insrsid157761\charrsid15610012  http://www.fda.gov/oc/po/thompson/medsact.html. }}}{
\insrsid157761\charrsid2900592   After asking the FDA to reexamine MEDSA to evaluate whether it poses any additional health risks to U.S. consumers and the Office of the Assistant Secretary for Planning and Evaluation (\'93OASPE\'94
) to examine whether the new law will result in a significant cost savings, Thompson also decided not to implement MEDSA.}{\cs16\super\insrsid157761\charrsid2900592 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012  }}}{\insrsid157761\charrsid2900592   
\par }\pard \qj \li1170\ri1170\widctlpar\tx1080\aspalpha\aspnum\faauto\adjustright\rin1170\lin1170\itap0\pararsid157761 {\insrsid157761\charrsid10628549 
The review by the Office of the Assistant Secretary for Planning and Evaluation (OASPE) concludes there are significant disincentives for reimportation under the MEDS Act, including the costs as
sociated with documenting, sampling and testing, the potential relabeling requirements and related costs and risk associated with such requirements, the overall risk of increased legal liability, the costs associated with the management of inventories by 
w
holesalers and pharmacists, and the risk to existing and future contractual relationships between all parties involved. Moreover, there are a number of reasons (including potential responses by foreign governments) why lower foreign prices may not transla
te into lower prices for U.S. consumers.}{\f359\fs32\insrsid157761\charrsid10628549  }{\insrsid157761\charrsid10628549 
Insufficient information exists for me to demonstrate that implementation of the law will result in significant reduction in the cost of drug products to the American consumer.}{\cs16\super\insrsid157761\charrsid2900592 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id. }}}{\insrsid157761\charrsid2900592   
\par 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\tx1080\tx8640\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid2900592 Because Thompson could not make the
 required safety and cost determinations necessary under MEDSA he chose not implement the Act.}{\cs16\super\insrsid157761\charrsid10628549 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id. }}}{\insrsid157761\charrsid2900592 
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid2900592 \tab 
\par }\pard \qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\b\insrsid157761\charrsid11742280 Medicare Prescription Drug, Improvement and Modernization Act of 2003
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\b\insrsid157761\charrsid11742280 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid2900592 The Medicare Prescription Drug, Improvement and Modernization Act of 2003 (\'93MMA\'94) is th
e most recently passed legislation that addresses the reimportation issue by amending the FDCA.  The MMA directs the Secretary of HHS to promulgate regulations permitting pharmacists and wholesalers to import prescription drugs from Canada}{
\cs16\super\insrsid157761\charrsid2900592 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 
\chftn }{\fs22\insrsid157761\charrsid15610012  MEDSA allows reimportation from several other countries.}}}{\insrsid157761\charrsid2900592  into the United States under specific conditions.}{\cs16\super\insrsid157761\charrsid2900592 \chftn {\footnote 
\pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  21 U.S.C. 3
84 (2006).}}}{\insrsid157761\charrsid2900592 
  The specific conditions are designed to ensure that the reimported prescription drugs are safe and effective.  For example, importers are required to provide information and records regarding the names and amounts of ac
tive ingredient of the products, provide documentation demonstrating that each batch of shipment was statistically sampled and tested for authenticity and degradation and provide }{\insrsid157761\charrsid11742280 
certification from the importer or manufacturer that the product is approved for marketing in the U.S., meets all labeling requirements, and is not adulterated or misbranded.}{\cs16\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.}}}{\insrsid157761\charrsid11742280   This is only a small sample of the MMA\rquote s safeguard requirements.  In addition to allowing pharmacists and wholesalers to reimport prescription drugs, the MM
A also contains a provision that accords the Secretary of HHS \'93waiver authority for importation by individuals.\'94}{\cs16\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  21 U.S.C. 384(j) (2006).}
}}{\insrsid157761\charrsid11742280   Under this provision the Secretary may exercise discretion to permit individuals to make importations from Canada if it is clearly for person
al use and it does not appear to present an unreasonable risk to the individual.}{\cs16\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  21 U.S.C. 384(j)(1)(B) (2006).}}}{\insrsid157761\charrsid11742280 
  Additionally, the prescription drug must be imported from a licensed pharmacy in quantities that do not exceed a 90-day supply and must be accompanied by a copy of a valid prescription.}{\cs16\super\insrsid157761\charrsid11742280 \chftn {\footnote 
\pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012 
 21 U.S.C. 384(j)(3) (2006).}}}{\insrsid157761\charrsid11742280 
  In order that individuals may know whether a particular importation will be permitted, the section also mandates that the Secretary of HHS issue a guidance that describes circumstances in which waivers will be granted.}{
\cs16\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  21 U.S.C. 384(j)(2)(B) (2006).}}}{\insrsid157761\charrsid11742280   
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid11742280 \tab The reimportation 
provision of the MMA, like MEDSA, only becomes effective if the Secretary of HHS certifies to Congress that the implementation of the section will \'93
pose no additional risk to the public's health and safety and result in a significant reduction in the cost of covered products to the American consumer.\'94}{\cs16\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  21 U.S.C. 384(l) (2006).}
}}{\insrsid157761\charrsid11742280   As was stated earlier, no Secretary of HHS, to date, has made such a certification.
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid11742280 
\par }{\insrsid157761\charrsid2900592 \tab }{\b\insrsid157761\charrsid2900592 C. Recent Legislation
\par 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid2900592 \tab In 2003, }{\insrsid157761\charrsid857920 pursuant to Congressional findings that \endash  (}{
\insrsid157761\charrsid857920 1) Americans unjustly pay up to 1000 percent 
more to fill their prescriptions than consumers in other countries; (2) the United States is the world's largest market for pharmaceuticals yet consumers still pay the world's highest prices; (3) an unaffordable drug is neither safe nor effective, (4) and
 allowing and structuring the importation of prescription drugs ensures access to affordable drugs, thus providing a level of safety to American consumers they do not currently enjoy \endash  the House passed the Pharmaceutical Market Access Act of 2003.}
{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 
\chftn }{\fs22\insrsid157761\charrsid15610012  Pharmaceutical Market Access Act of 2003, H.R. 2427, 108th Cong. \'a7 2 (2003). S.2137 is the related bill that was introduced in the House.}}}{\insrsid157761\charrsid857920   Had it 
passed in the Senate it would have amended the current law to require the Secretary of HHS to issue regulations, within 180 days of the bill\rquote 
s enactment, allowing for the importation of FDA-approved prescription drugs from FDA-approved foreign facilities by pharmacists, wholesalers, and qualifying individuals from Canada and certain other countries.}{\cs16\super\insrsid157761\charrsid857920 
\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{
\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012  at \'a7 4. }}}{\insrsid157761\charrsid857920  
\par \tab In April of the following year, Senator Grassley introduced the Reliable Entry for Medicines at Everyday Discounts Through Importation with Effective Safeguards Act of 2004.}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\fs22\insrsid157761\charrsid15610012 Reliable Entry for Medicines at Everyday Discounts through Importation with Effective Safeguards Act of 2004, S. 2307, }{\fs22\insrsid157761\charrsid15610012 108th Cong. (2004).}}}{\insrsid157761\charrsid857920 
  This bill would have required the Secretary to promulgate regulations permitting importation of qualifying prescription drugs from permitted countries by licensed pharmacists and wholesalers as well as individuals.}{
\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 
\chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id.; }{\fs22\insrsid157761\charrsid15610012 Qualifying countries include Canada and any other country designated by the Secretary.}}}{\insrsid157761\charrsid857920 
 As a safety measure the bill }{\insrsid157761\charrsid11742280 
set conditions on registered exporters, including that they must: (1) submit to the jurisdiction of U.S. courts, (2) export only qualifying drugs manufactured in and obtained from registered establishments, (3) permit facility and record inspection
s and place of business monitoring, (4) pay user fees to cover the costs of administering the Act, and (5) be authorized under foreign law to dispense drugs that are only safe for use under supervision of a licensed practitioner.}{
\cs16\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id.  }}}{\insrsid157761\charrsid11742280   The bill was never voted upon.}{\insrsid157761\charrsid857920 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid857920 \tab 
In this same month, Senator Dorgan introduced the Pharmaceutical Market Access and Drug Safety Act which would have required the Secretary to promulgate regulations allowing the importation of prescription drugs by pharmacists and wholesalers who a
re registered importers}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Requires pharmacists and wholesalers to receive certification as registered importers.}}}{\insrsid157761\charrsid857920 
 from Canada within 90 days of passage of the Act and from selected other countries within one year.}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\fs22\insrsid157761\charrsid15610012 
Pharmaceutical Market Access and Drug Safety Act, S. 2328, 108th Cong. (2004).}{\fs22\insrsid157761\charrsid15610012  }}}{\insrsid157761\charrsid857920 
  Additionally, it would have allowed for the immediate importation of prescription drugs for personal use from licensed Canadian pharmacies.}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid1665427 \chftn }{\fs22\insrsid157761\charrsid1665427  }{
\i\fs22\insrsid157761\charrsid1665427 Id.  }}}{\insrsid157761\charrsid857920 
  Like the Pharmaceutical Market Access Act, Congressional findings recognized that Americans unjustly pay up to five times more to fill their prescriptions than consumers in other countries; a prescription drug is neither safe nor effective to 
an individual who cannot afford it; and that allowing and structuring the importation of prescription drugs to ensure access to safe and affordable drugs approved by the FDA will provide consumers with more safety than they currently enjoy.}{
\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 
\chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id. }{\fs22\insrsid157761\charrsid15610012 at \'a7 2. }}}{\insrsid157761\charrsid857920   This bill passed in the House but eventually died in the Senate.
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid857920 \tab The 108}{\super\insrsid157761\charrsid857920 th}{\insrsid157761\charrsid857920 
 Congress also introduced yet another bill attempting to allow reimportation of prescription drugs.  The Safe Importing of Medical Products and Rx Therapies Act, which originated in the Senate w
ould have allowed registered pharmacies, internet pharmacies (domestic and overseas), wholesalers, overseas drug importation facilities and individuals to import drugs into the United States from permitted countries.}{
\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 
\chftn }{\fs22\insrsid157761\charrsid15610012  }{\fs22\insrsid157761\charrsid15610012 Safe Im
porting of Medical Products and Rx Therapies Act, S. 2493, 108th Cong. (2004).  H.R. 4923 is an identical bill that was introduced in the House.  Like its Senate counterpart, it was never voted on.}}}{\insrsid157761\charrsid857920 
  Individuals would be allowed to import drugs immediately upon passage of the bill and all others within one year of enactment.}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.}}}{\insrsid157761\charrsid857920    Like many of the other bills, it was never voted upon.   
\par \tab All of the aforementioned bills contained provisions that required mechanisms designed to ensure the saf
ety of the reimported drug.  The following are examples of the types of safety mechanisms that a bill may have required: chain-of-custody documentation from importers and exporters, extensive labeling and testing requirements, and suspension of imported p
rescription drugs determined to be counterfeit, contaminated, or otherwise adulterated.}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  H.R. 2427, 108th Cong. (2003); }{\fs22\insrsid157761\charrsid15610012 S. 2307, }{
\fs22\insrsid157761\charrsid15610012 108th Cong. (2004); }{\fs22\insrsid157761\charrsid15610012 S. 2328, 108th Cong. (2004); S. 2493, 108th Cong. (2004).  }}}{\insrsid157761\charrsid857920 
  The Safe Importing of Medical Products and Rx Therapies Act would have even required use of a prescription drug electronic track and trace technology.}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012 
 S.2493, 108th Cong. (2004).}}}{\insrsid157761\charrsid857920   Despite the employment of these safety provisions in the bills, none have become law.}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012 
 Other bills that were introduced in the 108}{\fs22\super\insrsid157761\charrsid15610012 th}{\fs22\insrsid157761\charrsid15610012  Congress but never passed include H.R. 3710, S. 2137 (Pharmaceutical Market Act of 2003), H.R. 4790 (Drug Im
portation Promotion and Safety Act), and H.R. 4923 (Safe IMPORT Act of 2004)}}}{\insrsid157761\charrsid857920   
\par \tab The current Congress (109}{\super\insrsid157761\charrsid11742280 th}{\insrsid157761\charrsid857920 ) has also introduced a slew of bills regarding reimportation.}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012 
 These bills include: S. 109 (Pharmaceutical Market Access Act of 2005), S. 16 (Affordable Health Care Act), H.R. 328 (Pharmaceutical Market Access Act of 2005), S. 184 (Safe IMP
ORT Act of 2005), H.R. 563 (Prescription Drug Affordability Act of 2005), H.R. 578 (Prescription Drug Affordability Act), S. 334 (Pharmaceutical Market Access and Drug Safety Act of 2005), H.R. 700 (Pharmaceutical Market Access and Drug Safety Act of 2005
), H.R. 573 (Safe IMPORT Act of 2005).}}}{\insrsid157761\charrsid857920   Most are reintroductions of bills from the previous Congress and the majority have been referred to Committees and are awaiting further Congressional action.
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid857920 
\par {\listtext\pard\plain\b\insrsid157761\charrsid11742280 \hich\af0\dbch\af0\loch\f0 D.\tab}}\pard \ql \fi-360\li1080\ri0\widctlpar\jclisttab\tx1080\aspalpha\aspnum\faauto\ls14\adjustright\rin0\lin1080\itap0\pararsid157761 {\b\insrsid157761\charrsid11742280 
Summary of Current Status of Reimportation Law, including FDA\rquote s Personal Use Policy
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\b\insrsid157761\charrsid11742280 
\par }{\insrsid157761\charrsid857920 \tab Currently, under the FDCA, only the U.S. manufacturer of a prescription drug can reimport prescript
ion drugs into the U.S; however, the Secretary of HHS is authorized to allow the importation of any drugs that are required for emergency medical care.}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  21 U.S.C. \'a7
 381(d)(1)(2) (2006).}}}{\insrsid157761\charrsid857920   Therefore, it is technically illegal for individual consumers or online pharmacies to reimport a presc
ription drug back into the U.S., even if the drug was originally manufactured in this country and even if it otherwise complies with the FDCA.}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Jody Feder, }{
\i\fs22\insrsid157761\charrsid15610012 Prescription Drug Importation and Internet Sales: A Legal Overview}{\fs22\insrsid157761\charrsid15610012 , CRS Report for Congress, CRS-4, Jan. 8, 2004.}}}{\insrsid157761\charrsid857920   
\par \tab Although MEDSA provided a little more reimportation flexibility by allowing pharmacists and wholesalers to im
port prescription drugs from foreign countries if specific safety precautions are followed, because no Secretary of HHS has certified that their implementation of the provision would pose no additional risk to the public\rquote 
s health and safety and would result in a significant reduction in the cost of covered products to the American consumer, pharmacists and wholesalers cannot reimport prescription drugs.}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote 
\pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id. }{\fs22\insrsid157761\charrsid15610012 (citing Pub. L. No. 106-387, 21 U.S.C. \'a7 384).}}}{\insrsid157761\charrsid857920  
\par \tab Some may believe that individuals are permitted to reimport prescription drugs for personal use.  However, this is incorrect; the right is much more narrow.}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\fs22\insrsid157761\charrsid15610012 While individuals may not legally import prescription drugs under any of the current statutes, as with any law, the FDA has some enforcement discretion and has not yet focused its resources on personal importations.}}}
{\insrsid157761\charrsid857920   The MMA authorizes the FDA to allow, by regulatory waiver, individuals to import }{\i\insrsid157761\charrsid857920 unapproved }{\insrsid157761\charrsid857920 prescription drugs for personal use under certain circumstances.
}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Feder, }{\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012  note 59, at CRS-5.}}}{\insrsid157761\charrsid857920 
  Reimportation implies that a drug manufactured and }{\i\insrsid157761\charrsid10628549 approved}{\insrsid157761\charrsid857920 
 in the U.S., then exported to another country, is then imported back into the U.S.  Thus, by definition, reimported drugs are not among those that are permitted via regulatory waiver by the MMA.  The FDA\rquote s personal importation policy}{
\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 
\chftn }{\fs22\insrsid157761\charrsid15610012  The FDA\rquote s personal use policy is not a law or regulation but rather a guide designed for FDA personnel.}}}{\insrsid157761\charrsid857920  a
lso does not permit reimportation; it explicitly only allows enforcement discretion to allow entry of }{\i\insrsid157761\charrsid11742280 unapproved}{\insrsid157761\charrsid857920  }{\insrsid157761\charrsid11742280 
prescription drugs under the following conditions:
\par {\listtext\pard\plain\f3\insrsid157761\charrsid11742280 \loch\af3\dbch\af0\hich\f3 \'b7\tab}}\pard \ql \fi-360\li787\ri0\widctlpar\jclisttab\tx787\aspalpha\aspnum\faauto\ls13\adjustright\rin0\lin787\itap0\pararsid157761 {\insrsid157761\charrsid11742280 
Intended use is for a serious condition for which effective treatment may not be available domestically; 
\par {\listtext\pard\plain\f3\insrsid157761\charrsid11742280 \loch\af3\dbch\af0\hich\f3 \'b7\tab}Product is considered not to represent an unreasonable risk; 
\par {\listtext\pard\plain\f3\insrsid157761\charrsid11742280 \loch\af3\dbch\af0\hich\f3 \'b7\tab}Product is for personal use; 
\par {\listtext\pard\plain\f3\insrsid157761\charrsid11742280 \loch\af3\dbch\af0\hich\f3 \'b7\tab}No known commercialization or promotion to U.S. residents by those involved in the distribution of the product; 
\par {\listtext\pard\plain\f3\insrsid157761\charrsid11742280 \loch\af3\dbch\af0\hich\f3 \'b7\tab}Individual seeking to import the product affirms in writing that it is for the patient's own use and provides the name and}{
\f360\fs26\cf1\insrsid157761\charrsid421317  }{\insrsid157761\charrsid11742280 address of the U.S. licensed doctor responsible for his or her treatment with the product or provides evidence that the product is for the continuation of a treatment beg
un in a foreign country;
\par {\listtext\pard\plain\f3\insrsid157761\charrsid11742280 \loch\af3\dbch\af0\hich\f3 \'b7\tab}Importation does not exceed more than a three-month supply of the unapproved products.}{\cs16\super\insrsid157761\charrsid1665427  }{
\cs16\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  O}{\scaps\fs22\insrsid157761\charrsid15610012 ffice of regulatory affairs, Food and Drug Administration}{\fs22\insrsid157761\charrsid15610012 , }{
\i\fs22\insrsid157761\charrsid15610012 Coverage of Personal Importations}{\fs22\insrsid157761\charrsid15610012 , }{\scaps\fs22\insrsid157761\charrsid15610012 Regulatory Procedures Manual, }{\i\fs22\insrsid157761\charrsid15610012 available at }{
\fs22\insrsid157761\charrsid15610012 http://www.fda.gov/ora/compliance_ref/rpm_new2/ch9pers.html.  }}}{\insrsid157761\charrsid11742280 
\par }\pard \ql \li67\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin67\itap0\pararsid157761 {\insrsid157761\charrsid11742280 
Thus at this point, with regard to reimportation, only the original manufacturer of a prescription drug is legally allowed to reimport into the U.S.
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid857920 
\par \tab }{\b\insrsid157761\charrsid857920 E.  Penalties for Illegal Reimportation
\par 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\b\insrsid157761\charrsid11742280 \tab }{\insrsid157761\charrsid11742280 
Any entities or individuals currently reimporting or contemplating reimporting prescription drugs must consider the penalties that must be faced especially considering they are not minor.   Any business or
 individual knowingly reimporting prescription drugs in violation of the FDCA is subject to a felony offense punishable by up to ten years in prison or up to $250,000 in fines, or both.}{\cs16\super\insrsid157761\charrsid11742280 \chftn {\footnote 
\pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  21 U.S.C. 
\'a7 333(b)(1), 381(d)(1) (2006).}}}{\insrsid157761\charrsid11742280   Additionally, federal courts may issue injunctions against violators in order to enjoin violations.}{\cs16\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  21 U.S.C. \'a7
 332 (2006).}}}{\insrsid157761\charrsid11742280 
\par \tab Individuals and businesses must also keep in mind that those who aid and abet a criminal violation of the FDCA, or conspire to violate it, can also be found criminally liable.}{\cs16\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Feder, }{
\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012  note 59 at CRS-7 (citing Letter from William K. Hubbard, Associate Commissioner for Policy and Planning, Food and Drug Admini
stration, to Robert P. Lombardi, Esq., The Kullman Firm 1 (Feb. 12, 2003), at http://fda.gov/ora/import/kullman.pdf).}}}{\insrsid157761\charrsid11742280   Under federal criminal law, generally, it is
 a separate crime to aid or abet any criminal offense or to conspire to commit a criminal offense against the U.S.}{\cs16\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012  (citing 18 U.S.C. \'a7\'a72, 371).}}}{\insrsid157761\charrsid11742280 
  Therefore, illegal reimporters face the potential of being charged with these offenses as well.  Additionally, businesses that assist or fa
cilitate in the reimportation of prescription drugs may also risk these penalties as the FDCA explicitly forbids the causing of reimportation and their facilitation may be deemed as \'93causing\'94 violations of the FDCA.}{
\cs16\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id. }{\fs22\insrsid157761\charrsid15610012 (citing 21 U.S.C. \'a7331).}}}{\insrsid157761\charrsid11742280 
\par \tab Despite these hefty penalties, violati
ons have not been heavily enforced against individuals as the government has been utilizing its enforcement discretion against individuals and instead has been focusing its enforcement resources against businesses. 
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid11742280 
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\b\scaps\insrsid157761\charrsid7996244 State and Local Responses
\par }{\b\insrsid157761\charrsid857920 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid857920 \tab Despite the
 federal prohibition on reimportation of prescription drugs except by the original U.S. manufacturer and a warning by William K. Hubbard}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012 
 Associate Commissioner for Policy and Planning for the FDA}{\fs22\insrsid157761\charrsid15610012  }}}{\insrsid157761\charrsid857920  to state and private entities attempting to import drugs in the U.S. that drugs can be imported only if they are FDA-a
pproved and comply with FDA approval in all respects such as manufacturing location, formulation, source and specifications of active ingredients and processing methods, many states and localities have implemented or are developing programs that would ass
ist their citizens in purchasing drugs from Canada.}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  21 C.F.R. \'a7314.50 (2006); Sona Ashchian, Note, }{\i\fs22\insrsid157761\charrsid15610012 
Importing/Reimporting Prescription Drugs From Canada to the United States: Temporary Relief for High Drug Prices?}{\fs22\insrsid157761\charrsid15610012 , 11 }{\scaps\fs22\insrsid157761\charrsid15610012 Sw. J. L. & Trade Am}{
\fs22\insrsid157761\charrsid15610012 . 323, 326-27 (2005) (citing Letter from William K. Hubbard, Associate Commissioner for Policy and Planning, to Gregory Gonot, Deputy Attorney General of the State of California (Aug. 25, 2003), }{
\i\fs22\insrsid157761\charrsid1665427 available at}{\fs22\insrsid157761\charrsid15610012  http://www.fda.gov/opacom/gonot.html (visited April 15, 2005).}}}{\insrsid157761\charrsid857920 
  Some states have implemented/developed these programs so that their citizens can gain access to prescription drugs that would otherwise be inaccessible to them due to their high cost while others utilize the programs as a means of cutting the states
\rquote  healthcare costs.}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 See}{\fs22\insrsid157761\charrsid15610012  Ashchian, }{\i\fs22\insrsid157761\charrsid15610012 supra }{
\fs22\insrsid157761\charrsid15610012 note 71, at 332; Anthony F. Andrisano, Jr., Comment, }{\i\fs22\insrsid157761\charrsid15610012 
To the U.S. Government: Whether or Not Reimportation is the Answer, Something Must be Done to Help Americans Afford Their Necessary Prescription Drugs!}{\fs22\insrsid157761\charrsid15610012 , 23 }{\scaps\fs22\insrsid157761\charrsid1665427 Penn St. Int
\rquote l L. Rev}{\fs22\insrsid157761\charrsid15610012 . 897, 920 (2005); }{\i\fs22\insrsid157761\charrsid15610012 see also}{\fs22\insrsid157761\charrsid15610012 , Andrew Harris, Student Article, }{\i\fs22\insrsid157761\charrsid15610012 Recent 
Congressional Responses to Demands for Affordable Pharmaceuticals}{\fs22\insrsid157761\charrsid15610012 , 16 }{\scaps\fs22\insrsid157761\charrsid1665427 Loy. Consumer L. Rev.}{\fs22\insrsid157761\charrsid15610012  219, 223 (2004).}}}{
\insrsid157761\charrsid857920   The following is a summary of the various states\rquote  programs.
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid857920 
\par 
\par 
\par {\listtext\pard\plain\b\insrsid157761\charrsid11742280 \hich\af0\dbch\af0\loch\f0 I.\tab}}\pard \ql \fi-450\li1170\ri0\widctlpar\jclisttab\tx1080\aspalpha\aspnum\faauto\ls12\adjustright\rin0\lin1170\itap0\pararsid157761 {\b\insrsid157761\charrsid11742280 
States Against Reimportation
\par }\pard \ql \li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0\pararsid157761 {\b\insrsid157761\charrsid11742280 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\b\insrsid157761\charrsid15956527 \tab }{\insrsid157761\charrsid15956527 
Although it may appear that there are more states and localities who are in support of reimpor
tation than those that are against, this is most likely because the supporters appear to have received more media attention. However, there are a handful of states and localities that agree with the FDA and believe that reimportation is unsafe.  These sta
tes and localities are (1) unwilling to assist or encourage its citizens to engage in activity that is illegal and (2) willing to prevent businesses from engaging in illegal reimportaion.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote 
\pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Andrisano, }{
\i\fs22\insrsid157761\charrsid15610012 supra }{\fs22\insrsid157761\charrsid15610012 note 72, at 910.}}}{\insrsid157761\charrsid11742280 
\par }{\b\insrsid157761\charrsid15956527 \tab }{\insrsid157761\charrsid15956527 The state of Oklahoma was the first to take official action against
 a storefront distributor of prescription drugs.  It filed a complaint alleging that the distributor violated the Oklahoma Pharmacy Act by, among other things, assisting unlicensed Canadian pharmacies who sell and offer to sell prescription drugs.}{
\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Oklahoma State Bd. of Pharmacy v. Rx Depot, No. CJ-2003-2643 (District of Oklahoma County filed March 27, 2003).}}}{\insrsid157761\charrsid15956527   The st
ate sought to enjoin the distributor from violating the Oklahoma Pharmacy Act as well as seeking temporary and permanent injunctions to restrain it from continuing to sell prescription drugs.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote 
\pard\plain \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012 ; }{\i\fs22\insrsid157761\charrsid15610012 see also }{\fs22\insrsid157761\charrsid15610012 Andrisano, }{\i\fs22\insrsid157761\charrsid15610012 supra }{
\fs22\insrsid157761\charrsid15610012 note 72, at 920-21 (citing Alabama State Bd. of Pharmacy v. Disc. Drugs of Canada, No CV 03-1742 (Circuit Court of Jefferson County filed March 31, 2003), available at }{\field\flddirty{\*\fldinst {
\fs22\insrsid157761\charrsid15610012  HYPERLINK "http://www.nacds.org/user-assets/PDF_files/AL_BOP_Complaint.pdf" }{\f360\fs22\insrsid157761\charrsid15610012 {\*\datafield 
00d0c9ea79f9bace118c8200aa004ba90b02000000170000004000000068007400740070003a002f002f007700770077002e006e0061006300640073002e006f00720067002f0075007300650072002d006100730073006500740073002f005000440046005f00660069006c00650073002f0041004c005f0042004f005000
5f0043006f006d0070006c00610069006e0074002e007000640066000000e0c9ea79f9bace118c8200aa004ba90b8000000068007400740070003a002f002f007700770077002e006e0061006300640073002e006f00720067002f0075007300650072002d006100730073006500740073002f005000440046005f00660069
006c00650073002f0041004c005f0042004f0050005f0043006f006d0070006c00610069006e0074002e007000640066000000}}}{\fldrslt {\fs22\insrsid157761\charrsid15610012 http://www.nacds.org/user-assets/PDF_files/AL_BOP_Complaint.pdf}}}{
\fs22\insrsid157761\charrsid15610012  and North Carolina Bd. of Pharmacy v. Canada Drug Outlet, Inc., No. 3 CVS04986 (N.C. Superior Court Division filed Oct. 15, 2003), available at http://www.nacds.org/user-assets/PDF_files/NC_BOP_v_Canada.pdf).}}}{
\insrsid157761\charrsid15956527  The Boards of Pharmacy in both Alabama and North Carolina filed similar complaints against storefront distributors.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Andrisano, }{
\i\fs22\insrsid157761\charrsid15610012 supra }{\fs22\insrsid157761\charrsid15610012 note 72, at 920-21.}}}{\insrsid157761\charrsid15956527 
\par \tab Arizona and Oregon have taken a different approach.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id. }{\fs22\insrsid157761\charrsid15610012 at 921.}}}{
\insrsid157761\charrsid15956527   These states have decided to take steps to warn consumers of the dangers of acquiring reimported drugs from storefront distributors, either by issuing a letter to the state\rquote 
s Better Business Bureau asking it to warn consumers about the risks associated with purchasing prescription drugs from Canada or by issuing statements regarding the illegality and danger of storefront distributors.}{
\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id. }{\fs22\insrsid157761\charrsid15610012 
(citing Arizona Board of Pharmacy Urges Better Business Bureau to Warn Consumers About Prescription Drugs From Canada: You Can't Trust the Source; Letter Cites Repeat Felon Operating Canadian Drug Import Service, PR Newswire, May 9, 2003, }{
\i\fs22\insrsid157761\charrsid1665427 available at}{\fs22\insrsid157761\charrsid15610012  http://www.findarticles.com/cf_dls/m4PRN/2003_May_9/101488124/p1/article.jhtml?term= and Gary A. Schnabel, Statement regarding Oregon storefront businesse
s that solicit drug therapy patients to hand over prescriptions to be filled in Canada, Oregon Board of Pharmacy, Oct. 17, 2003, available at http://www.nacds.org/user-assets/Word_files/OR_Statement_Storefronts.DOC).}}}{\insrsid157761\charrsid15956527 

\par \tab Montana\rquote s Board of Pharmacy sent a storefront distributor a cease and desist letter, informing it that it was in violation of Montana\rquote 
s Pharmacy Practice Act by aiding and abetting a pharmacy not licensed in the state, engaging in unauthorized advertising, and finally, acting as unlicensed technicians.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012 
 Letter from Montana Board of Pharmacy to Club Medzrx, at http://www.nacds.org/user-assets/PDF_files/Club_Medz_Cease_Desist_MT.pdf.}}}{\insrsid157761\charrsid15956527   
\par \tab In California, both in 2004 and in 2005 the legislature passed a bill that would have allowed the state to create a website linking residents to Canadian pharmacies.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid157761 \chftn }{\insrsid157761  }{\fs22\insrsid157761\charrsid14028412 
Melicia Seay, Drug Importation, Health Policy Tracking Service\endash Issue Briefs 060403.3, Apr. 3, 2006.}}}{\insrsid157761\charrsid15956527  However, both years Governor Arnold Schwarzenegger vetoed the bills stating that \'93}{
\insrsid157761\charrsid14028412 [i]mporting drugs from Canada or assisting residents in their efforts to do so would violate federal law and could expose the state to civil, criminal and tort liability."}{\cs16\super\insrsid157761\charrsid14028412 \chftn 
{\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid157761 \chftn }{\insrsid157761  }{\i\insrsid157761 Id}}}{
\insrsid157761\charrsid15956527 
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid11742280 
\par {\listtext\pard\plain\b\insrsid157761\charrsid15956527 \hich\af0\dbch\af0\loch\f0 II.\tab}}\pard \ql \fi-720\li1440\ri0\widctlpar\jclisttab\tx1440\aspalpha\aspnum\faauto\ls12\adjustright\rin0\lin1440\itap0\pararsid157761 {
\b\insrsid157761\charrsid15956527 States Supporting Reimportation
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\b\insrsid157761\charrsid15956527 \tab 
\par 
\par {\listtext\pard\plain\b\insrsid157761\charrsid15956527 \hich\af0\dbch\af0\loch\f0 A.\tab}}\pard \ql \fi-360\li1080\ri0\widctlpar\jclisttab\tx1080\aspalpha\aspnum\faauto\ls15\adjustright\rin0\lin1080\itap0\pararsid157761 {\b\insrsid157761\charrsid15956527 
Alabama
\par }\pard \ql \li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0\pararsid157761 {\b\insrsid157761\charrsid15956527 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid857920 \tab Montgomery, Alabama was the first city to institute a prescription drug importation program with Canada.}{
\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 
\chftn }{\fs22\insrsid157761\charrsid15610012  Andrisano, }{\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012  note 72, at 922 (citing Julie Appleby, }{\i\fs22\insrsid157761\charrsid1665427 
More Cities, States Opt for Canadian Drugs; FDA Might be Forced to Challenge Each Program,}{\fs22\insrsid157761\charrsid15610012  USA Today, Dec. 23, 2003, }{\i\fs22\insrsid157761\charrsid15610012 available at}{\fs22\insrsid157761\charrsid15610012 
 http://www.usatoday.com/money/industries/health/drugs/2003-12-23-canadadrugs_x.  Many people may believe that New Hampshire
 or Springfield and Boston, Massachusetts were the first, but this is only because these cities/states grabbed headlines while Montgomery, AL chose not to seek attention to its program.  }}}{\insrsid157761\charrsid857920 
  Its program started in December 2003 and is a voluntary part of the city\rquote s health benefit program for city employees and retirees who want to get their drugs from a Canadian pharmacy.}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote 
\pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Appleby, }{
\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012  note 82, n.82.}}}{\insrsid157761\charrsid857920   The program is claimed to have saved its citizens a half-million dollars a year.}{
\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 
\chftn }{\fs22\insrsid157761\charrsid15610012  Wyatt Andrews, }{\i\fs22\insrsid157761\charrsid15610012 The Issues: Rx Drug Imports}{\fs22\insrsid157761\charrsid15610012 
, CBS News, Sept. 9, 2004, http://www.cbsnews.com/stories/2004/09/09/eveningnews/main642415.shtml.}}}{\insrsid157761\charrsid857920   
\par 
\par }{\b\insrsid157761\charrsid15956527 \tab B.  Massachusetts
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\b\insrsid157761\charrsid15956527 \tab }{\insrsid157761\charrsid15956527 
SPRINGFIELD - When Mayor of Springfield, Massachusetts, Michael Albano, realized his city\rquote s healthcare costs had risen over 100 percent since 1996 and that prescription drug costs had risen from $8.6 million (1996) to 18 million (2004) for the city
\rquote s employees and retirees, he implemented a prescription drug reimportation program on July 8, 2003.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 See}{\fs22\insrsid157761\charrsid15610012  Medical Marketing Association, Prescription Drug Reimportation \endash  Interview with Michael Albano, }{\fs22\insrsid157761\charrsid1665427 
http://www.mmanet.org/news/newsletter_Feb04.htm}{\fs22\insrsid157761\charrsid15610012  [hereinafter Medical Marketing Association].}}}{\insrsid157761\charrsid15956527   This decision made his city one of the first to implement such a program.}{
\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id.}}}{\insrsid157761\charrsid15956527   The program\rquote 
s purpose is to reduce prescription drug costs for the city of Springfield, as well as its employees, retired employees, and their dependents by reimporting drugs for chronic conditions from Canada.}{\cs16\super\insrsid157761\charrsid15956527 \chftn 
{\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id. }}}{\insrsid157761\charrsid15956527   
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid15956527 \tab 
Participation in the program is voluntary and once enrolled, all the participant must do is receive a prescription for a maintenance medication}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012 
 Prescriptions are generally for 90-day supply medications, not for immediate or emergency situations.  }}}{\insrsid157761\charrsid15956527  from his or her physician.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 See }{\fs22\insrsid157761\charrsid15610012 Medical Marketing Association, }{\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012  note 85.}}}{\insrsid157761\charrsid15956527 
  The prescription is sent to the Canadian provider, reviewed by a physician in Canada, referred to a pharmacist, filled, then mailed to the customer.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id. }}}{\insrsid157761\charrsid15956527   Lack of a co-pay serves as an incentive for people to get their prescription filled from Canada rather than through the traditional sources.}{
\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 See Id; see also}{\fs22\insrsid157761\charrsid15610012  Ashchian}{\i\fs22\insrsid157761\charrsid15610012  supra}{
\fs22\insrsid157761\charrsid15610012 
 note 71, at 332 (citing Evening News with Dan Rather: Springfield, Massachusetts Mayor Offers City Workers the Chance to Buy Prescription Drugs from Canada (CBS television broadcast, Sept, 16, 2003), LEXIS, News Library, SCRIPT file). }}}{
\insrsid157761\charrsid15956527   Individuals still have the option to go to their neighborhood pharmacy, but will have to make a co-pay for doing so.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Medical Marketin
g Association, }{\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012  note 85.}}}{\insrsid157761\charrsid15956527  }{\b\highlight6\insrsid157761\charrsid11742280 
\par }{\b\insrsid157761\charrsid11742280 \tab }{\insrsid157761\charrsid11742280 BOSTON - The City of Boston instituted a pilot program that allowed its public employees and retirees to buy imported and reimported drugs from Canada in July of 2004.}{
\cs16\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 See }{\fs22\insrsid157761\charrsid15610012 Jonathan Finer, }{\i\fs22\insrsid157761\charrsid15610012 
Importing a Fight with Boston\rquote s Biotech Industry}{\fs22\insrsid157761\charrsid15610012 , }{\caps\fs22\insrsid157761\charrsid15610012 W}{\scaps\fs22\insrsid157761\charrsid15610012 ashington Post,}{\fs22\insrsid157761\charrsid15610012 
 Jun. 1, 2004, E01l; }{\i\fs22\insrsid157761\charrsid1665427 see also}{\fs22\insrsid157761\charrsid15610012  Affordable Prescription Drugs, City of Boston, http://www.cityofboston.gov/publichealth/prescription.asp.}}}{\insrsid157761\charrsid11742280 
  Through the voluntary program, employees and retirees with Blue Cross Blue Shield coverage are eligible to receive certain brand-name maintenance medications from a Canadian mail-order company.}{\cs16\super\insrsid157761\charrsid11742280 \chftn 
{\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  
City of Boston Meds by Mail, City of Boston, http://www.cityofboston.gov/publichealth/medsbymail.asp. }}}{\insrsid157761\charrsid11742280   To enroll in the program, individuals fill out a customer 
agreement and patient profile which must be completed by a doctor and then send these forms along with a prescription to the Canadian pharmacy.}{\cs16\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.}}}{\insrsid157761\charrsid11742280   Alternatively, the doctor can fax all this documentation to the pharmacy directly. }{\cs16\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.}}}{\insrsid157761\charrsid11742280   Individuals who use this
 program can order 90-day supplies of prescription drugs and make no co-payment for the medicines from this service nor do they have to pay shipping costs.}{\cs16\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.}}}{\insrsid157761\charrsid11742280   This provides an incentive for individuals to participate in the problem.  In order to ensure safe
ty the program claims that the Canadian pharmacies are selected by the City after a rigorous, competitive process that includes an on-site safety inspection, the prescription drugs ordered are manufactured by the same companies that provide medications to
 U.S. pharmacies, licensed pharmacists fill the prescriptions, and all drugs have been approved by Canada\rquote s equivalent of the FDA.}{\cs16\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.  }}}{\insrsid157761\charrsid11742280   }{\f359\fs26\cf8\insrsid157761\charrsid11742280 
\par }{\insrsid157761\charrsid11742280 
\par }{\b\insrsid157761\charrsid15956527 \tab C.  Wisconsin
\par }{\insrsid157761\charrsid857920 \tab Governer Jim Doyle, recognizing that too many of the citizens of his state were forced to make the unbeara
ble choice between food and medicines, launched a website in February 2004 to provide Wisconsin citizens access to cheaper drugs from Canada.}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 See }{\fs22\insrsid157761\charrsid15610012 Janice G. Inman, }{\i\fs22\insrsid157761\charrsid15610012 Drug Importation Task Force Completes Its Listening Sessions}{\fs22\insrsid157761\charrsid15610012 , }{
\scaps\fs22\insrsid157761\charrsid15610012 Pharmaceutical & Medical Device Bulletin, }{\fs22\insrsid157761\charrsid15610012 June 2, 2002, Vol. 4, No.6 at 1; }{\i\fs22\insrsid157761\charrsid15610012 see also }{\scaps\fs22\insrsid157761\charrsid15610012 S}{
\fs22\insrsid157761\charrsid15610012 tate of Wisconsin Prescription Drug Resource Center, http://www.drugsavings.wi.gov. }}}{\insrsid157761\charrsid857920 
  Through the website Wisconsin citizens can buy certain prescription drugs from pharmacies that have been visited and inspected on behalf of several state governors and found to be safe, reputable and reliable.}{\cs16\super\insrsid157761\charrsid857920 
\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{
\fs22\insrsid157761\charrsid15610012  }{\scaps\fs22\insrsid157761\charrsid15610012 S}{\fs22\insrsid157761\charrsid15610012 tate of Wisconsin Prescription Drug Resource Center, http://www.drugsavings.wi.gov.}}}{\insrsid157761\charrsid857920 
  In order to ensure safety, individuals can only order maintenance drugs and a prescription must first be filed through an individual\rquote s local pharmacist to ensure that there are no adverse reactions to the drug.}{
\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 
\chftn }{\fs22\insrsid157761\charrsid15610012  Press Release, Office of the Governor Jim Doyle, Governor Doyle Extends Agreements with Canadian Pharmacies \endash 
 Website Will Allow Wisconsin Citizens to Access Safe, Affordable Prescription Drugs for at Least Two More Years (Feb. 24, 2006) (http://www.wisgov.state.wi.us/journal_media_detail.asp?locid=19&prid=1766).}}}{\insrsid157761\charrsid857920 
  As the original agreements between the three contracting Canadian pharmacies was set to expire on February 27, 2006, Governor Doyle announced that Wisconsin will be extending agreements it has with t
he three Canadian pharmacies to continue to ship drugs to Wisconsin citizens for an additional two years.}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.}}}{\insrsid157761\charrsid857920   As part of the agreement the three facilities will be inspected and if any pharmacy is found to be unsuitable, the agreement with the pharmacy will be terminated.}{
\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 
\chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id. }}}{\insrsid157761\charrsid857920 
\par \tab As an additional measure, in October 2004, Governor Doyle joined together with Illinois Governor Rod. R. Blagojevich to launch the first program in the U.S. that allows citizens to purchase cheaper, safe prescription drugs from countires o
ther than Canada.}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id. }}}{\insrsid157761\charrsid857920 
  The I-SaveRx prescription drug importation program provides Wisconsin and Illinois residents with access to cheaper prescription drugs through a network of forty-five inspected and approved pharmacies and wholesalers in Canada as well a
s in the United Kingdom, and Ireland.}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id. }}}{\insrsid157761\charrsid857920 
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid857920 
\par {\listtext\pard\plain\b\insrsid157761\charrsid15956527 \hich\af0\dbch\af0\loch\f0 D.\tab}}\pard \ql \fi-360\li1080\ri0\widctlpar\jclisttab\tx1080\aspalpha\aspnum\faauto\ls16\adjustright\rin0\lin1080\itap0\pararsid157761 {\b\insrsid157761\charrsid15956527 
Illinois
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\b\insrsid157761\charrsid15956527 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid857920 \tab 
After issuing a feasibility report in October 2003 that found that employees and retirees can obtain safe and effective prescription medications at lower overall costs from Canada because the pharmacy prac
tice in the Canadian provinces of Manitoba and Ontario is equal to or superior to the pharmacy practice in the State of Illinois, Governor Blagojevich set up I-SaveRx.}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012 
 Report on the Feasibility of Employees and Retirees Safely and Effectively Purchasing Drugs from Canadian Pharmacies, }{\fs22\insrsid157761\charrsid1665427 http://www.affordabledrugs.il.gov/feasibility.cfm}{\fs22\insrsid157761\charrsid15610012 
 [hereinafter }{\i\fs22\insrsid157761\charrsid15610012 Illinois Feasibility Report}{\fs22\insrsid157761\charrsid15610012 ]; }{\i\fs22\insrsid157761\charrsid15610012 see also }{\fs22\insrsid157761\charrsid15610012 Andrisano }{
\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012  note 72, at 923-4.  }}}{\insrsid157761\charrsid857920   Through the I-SaveRx program, launched October 2004,  Illinois residents can purchase 
prescription drugs from Canada, the United Kingdom, and Ireland.}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Andrisano }{\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012 
 note 72, at 924; }{\i\fs22\insrsid157761\charrsid15610012 see also}{\fs22\insrsid157761\charrsid15610012 
 I-SaveRx, http://www.i-saverx.net/general.htm.  The I-SaveRx program also allows residents of Wisconsin, Kansas, Missouri, and Vermont to participate in the program.  }}}{\insrsid157761\charrsid857920 
   In order to purchase prescription drugs, residents must enroll in the program and must mail or have a doctor fax a completed health profile form and signed prescription to the I-SaveRx clearinghouse.}{\cs16\super\insrsid157761\charrsid857920  \chftn 
{\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012 
 Press Release, Office of the Governor Rod R. Blagojevich, Gov. Blagojevich Welcomes Vermont to the I-SaveRx Prescription Drug Importation Program (Feb. 18, 2005) (http://www.illinois.gov//PressReleases/ShowPressRelease.cfm?SubjectID=32&RecNum=3707). }}}{
\insrsid157761\charrsid857920    The clearinghouse then conducts an initial scan for appropriateness using the same drug interaction software used in Illinois pharmacies.}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id. }}}{\insrsid157761\charrsid857920  If the prescription passes the interaction test, it is turned over to a network physician in the coun
try from which the medication will be dispensed who will review and re-write the prescription for a local network pharmacy.}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.  }}}{\insrsid157761\charrsid857920   The pharmacy will perform a final safety check to ensure compliance with local laws and regulations before dispensing the medication.}{
\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid10628549 
\chftn  }{\i\fs22\insrsid157761\charrsid10628549 Id}{\i\insrsid157761\charrsid10628549 .}{\cs16\fs22\super\insrsid157761\charrsid10628549  }}}{\insrsid157761\charrsid857920 
  Residents can utilize a website or a toll-free number to purchase about 100 products the state has determined can be safely shipped from outside the U.S.}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Andrisano }{
\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012  note 72, at 924.}}}{\insrsid157761\charrsid857920   In addition to limiting the kinds of prescription drugs that can be purchased, the program bui
lds in several other safety measures to ensure that the products customers receive are safe.}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 See }{\fs22\insrsid157761\charrsid15610012 
I-SaveRx, http://www.i-saverx.net/general.htm.}}}{\insrsid157761\charrsid857920   Safety measures include only using pharmacies that have been inspected and approved by state regulatory agencies as well as only using pharmacies in countries th
at follow the same standards and procedures used by Illinois pharmacies.}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id. }}}{\insrsid157761\charrsid857920 
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid857920 
\par }{\b\insrsid157761\charrsid15956527 \tab E.  Vermont
\par 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid857920 \tab Before becoming a part of the I-SaveRx prescription drug importation program in 2005,}{
\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 
\chftn }{\fs22\insrsid157761\charrsid15610012  On February 17, 2005, Vermont Governor Jim Douglas signed legislation authorizing Vermont to join the program.  Press Release, Office of Governor Rod R. Blagokevich, }{\i\fs22\insrsid157761\charrsid15610012 
supra}{\fs22\insrsid157761\charrsid15610012  note 108.}}}{\insrsid157761\charrsid857920  in November 2003, Vermont attempted to obtain FDA approval for a pilot program 
under which the state would contract with a Canadian company that would take orders from current and retired state employees and their dependents and distribute the drugs by mail.}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Andrisano }{
\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012  note 72, at 925 (citing Pam Belluck}{\i\fs22\insrsid157761\charrsid15610012 , Vermont Will Sue U.S. for the Right to Import Drugs}{
\scaps\fs22\insrsid157761\charrsid15610012 , N.Y. Times}{\fs22\insrsid157761\charrsid15610012 , Aug. 11, 2004, at A.13).}}}{\insrsid157761\charrsid857920   The FDA rejected the request for approval, stating that the government cou
ld not ensure the safety of drugs from Canada.}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Pam Belluck}{\i\fs22\insrsid157761\charrsid15610012 , Vermont Will Sue U.S. for the Right to Import Drugs}{\scaps\fs22\insrsid157761\charrsid15610012 
, N.Y. Times}{\fs22\insrsid157761\charrsid15610012 , Aug. 11, 2004, at A.13.}}}{\insrsid157761\charrsid857920   In response, Vermont sued the Department of HHS and the FDA, becoming the first state to do so regarding this issue, claiming that the FDA
\rquote s denial is a violation of the Administrative Procedure Act.}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Statement on Vermont\rquote 
s Lawsuit on Importing Prescription Drugs from Canada, Aug. 20, 2004, http://www.fda.gov/bbs/topics/news/2004/NEW01107.html.  }}}{\insrsid157761\charrsid857920   The court eventually dismissed the suit, holding that }{\cf1\insrsid157761\charrsid11742280 
Vermont was asking the court to force the FDA to approve an illegal program under the FDCA.}{\cs16\cf1\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Vermont v. Leavitt, 405 F. Supp 2d 466, 479 (D. Vt. 2005).}}}{\cf1\insrsid157761\charrsid11742280 

\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid11742280 
\par }\pard \ql \li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0\pararsid157761 {\b\insrsid157761\charrsid15956527 F.  Minnesota
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\b\insrsid157761\charrsid15956527 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid857920 \tab Despite being denied FDA approval of its three-phase pilot importation program,  Minnesota Govern
or Pawlenty has launched the three-phase program designed to provide Minnesota state citizens with access to low cost brand name drugs from Canada.}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 See }{\fs22\insrsid157761\charrsid15610012 Letter from William K. Hubbard, Associate Commissioner for Policy and Planning for the FDA, to Time Pawlenty, Governor of Minnesota (Feb. 23, 2004), }{
\i\fs22\insrsid157761\charrsid15610012 available at }{\fs22\insrsid157761\charrsid15610012 http://www.fda.gov/oc/opacom/hottopics/importdrugs/pawlenty022304.html; Comm. on Commerce and Labor, 73rd Sess., at 10-11 (Nv. 2005) }{
\i\fs22\insrsid157761\charrsid15610012 available at }{\fs22\insrsid157761\charrsid1665427 http://www.leg.state.nv.us/73rd/Minutes/Senate/CL/Final/4428.pdf}{\fs22\insrsid157761\charrsid15610012   [hereinafter Senate Committee]}}}{
\insrsid157761\charrsid857920   Phase I began in January 2004 with Minnesota\rquote s Human Services and the Department of Administration launching of the website, }{\insrsid157761\charrsid15956527 www.MinnesotaRxConnect.com}{
\insrsid157761\charrsid857920 .}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 See}{\fs22\insrsid157761\charrsid15610012  State of Minnesota, Department of Health and Human Services, Minnesota
\rquote s Plan to Access Affordable Prescription Medicines [hereinafter Minnesota\rquote s Plan], }{\i\fs22\insrsid157761\charrsid15610012 available at }{\fs22\insrsid157761\charrsid1665427 
http://www.state.mn.us/portal/mn/jsp/content.do?hpage=true&contentid=536901941&contenttype=EDITORIAL&subchannel=null&sc3=null&sc2=null&id=-536885145&agency=Rx}{\fs22\insrsid157761\charrsid15610012 . }}}{\insrsid157761\charrsid857920 
  The website provides information about ordering prescription drugs from selected Canadian pharmacies}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Currently there are four participating Canadian pharmacies \endash 
 Canada US Pharmacy, CanadaDrugs.com, Granville Pharmacy, and Total Care Pharmacy.}}}{\insrsid157761\charrsid857920  as well as information about issues regarding affordable prescription drugs.  In order to ensure safety, 
Human Services set forth basic requirements that pharmacies had to meet in order to participate in the program.  Among these requirements is the willingness to allow Minnesota officials to visit their facilities and review their safety protocols.  Additio
nally, the selected pharmacies were required to agree to:
\par {\listtext\pard\plain\f3\insrsid157761\charrsid15956527 \loch\af3\dbch\af0\hich\f3 \'b7\tab}}\pard \qj \fi-360\li1440\ri720\widctlpar\jclisttab\tx1440\aspalpha\aspnum\faauto\ls5\adjustright\rin720\lin1440\itap0\pararsid157761 {
\insrsid157761\charrsid15956527 Maintain Canadian licensure to operate as a pharmacy and comply with applicable provincial and Canadian laws and regulations;
\par {\listtext\pard\plain\f3\insrsid157761\charrsid15956527 \loch\af3\dbch\af0\hich\f3 \'b7\tab}}\pard \qj \fi-360\li1440\ri720\widctlpar\tx1440\aspalpha\aspnum\faauto\ls5\adjustright\rin720\lin1440\itap0\pararsid157761 {\insrsid157761\charrsid15956527 
Maintain membership with the Canadian International Pharmacy Association;
\par {\listtext\pard\plain\f3\insrsid157761\charrsid15956527 \loch\af3\dbch\af0\hich\f3 \'b7\tab}Ensure that pharmacy employees have necessary Canadian licenses;
\par {\listtext\pard\plain\f3\insrsid157761\charrsid15956527 \loch\af3\dbch\af0\hich\f3 \'b7\tab}Require a prescription from a\~U.S. physician;
\par {\listtext\pard\plain\f3\insrsid157761\charrsid15956527 \loch\af3\dbch\af0\hich\f3 \'b7\tab}Provide only prescription medications that are approved by the Canada's Therapeutic Products Directorate for sale in Canada;
\par {\listtext\pard\plain\f3\insrsid157761\charrsid15956527 \loch\af3\dbch\af0\hich\f3 \'b7\tab}Exclude medicines for which there is no equivalent approved by the U.S. FDA for sale in the\~United States\~and medicines that cannot be safely shipped by mail; 

\par {\listtext\pard\plain\f3\insrsid157761\charrsid15956527 \loch\af3\dbch\af0\hich\f3 \'b7\tab}Refrain from providing medications in excess of a three-month supply or in excess of the amount approved by the person's\~U.S. physician;
\par {\listtext\pard\plain\f3\insrsid157761\charrsid15956527 \loch\af3\dbch\af0\hich\f3 \'b7\tab}Use the unopened manufacturer's packaging whenever possible;
\par {\listtext\pard\plain\f3\insrsid157761\charrsid15956527 \loch\af3\dbch\af0\hich\f3 \'b7\tab}Not fill orders for medicines if the customer indicates the purchase would represent his or her first use of that medication;
\par {\listtext\pard\plain\f3\insrsid157761\charrsid15956527 \loch\af3\dbch\af0\hich\f3 \'b7\tab}Provide periodic reports to Human Services regarding any complaints from customers accessing the pharmacy through the state's website.}{
\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id.}}}{\insrsid157761\charrsid15956527 
\par }\pard \qj \li1080\ri720\widctlpar\tx1440\aspalpha\aspnum\faauto\adjustright\rin720\lin1080\itap0\pararsid157761 {\insrsid157761\charrsid15956527 
\par }\pard \ql \fi720\li0\ri720\sl480\slmult1\widctlpar\tx1440\aspalpha\aspnum\faauto\adjustright\rin720\lin0\itap0\pararsid157761 {\insrsid157761\charrsid15956527 
In June 2005, after inspecting selected United Kingdom pharmacies, the program began allowing two participating Canadian pharmacies}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012 
 Granville Pharmacy and Total Care Pharmacy are the two United Kingdom affiliates.  }}}{\insrsid157761\charrsid15956527  to fill orders through their United Kingdom affiliates, but only when specifically requested or agreed to by the customer.}{
\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id.; see also}{\fs22\insrsid157761\charrsid15610012  Press Release, Office of Gover
nor Tim Pawlenty (February 22, 2006), http://www.governor.state.mn.us/Tpaw_View_Article.asp?artid=1754).}}}{\insrsid157761\charrsid15956527   }{\insrsid157761\charrsid857920 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid857920 \tab Phase II also involved a website, }{\insrsid157761\charrsid15956527 www.advantage-meds.com}{
\insrsid157761\charrsid857920 .  This website enabled state employees and their dependents to access selected prescription drugs at no cost (because they are using their state employee health plan) by ordering through a Canadian pharmacy.}{
\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 
\chftn }{\fs22\insrsid157761\charrsid15610012  Senate Committee, }{\i\fs22\insrsid157761\charrsid15610012 supra }{\fs22\insrsid157761\charrsid15610012 note 120, at 12; }{\i\fs22\insrsid157761\charrsid15610012 see also}{
\fs22\insrsid157761\charrsid15610012  Minnesota\rquote s Plan, }{\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012  note 121.}}}{\insrsid157761\charrsid857920 
 All the prescription drugs are approved for use in the U.S. and eight of the selected prescription drugs are the most-used, name brand prescription drugs in America.}{\cs16\super\insrsid157761\charrsid857920 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Senate Committee, }{
\i\fs22\insrsid157761\charrsid15610012 supra }{\fs22\insrsid157761\charrsid15610012 note 120, at 12; }{\i\fs22\insrsid157761\charrsid15610012 see also}{\fs22\insrsid157761\charrsid15610012  Minnesota\rquote s Plan, }{
\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012  note 121.}}}{\insrsid157761\charrsid857920   As with the }{\insrsid157761\charrsid15956527 
www.MinnesotaRxConnect.com website, inspectors perform continuing, ongoing inspections of the Canadian pharmacies to ensure quality and safety.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Senate Committee, }{
\i\fs22\insrsid157761\charrsid15610012 supra }{\fs22\insrsid157761\charrsid15610012 note 120, at 12.}}}{\insrsid157761\charrsid15956527 
\par \tab The third phase has more far reaching goals.  Minnesota is proposing that its program serve as a pilot project for purchasing prescription drugs through Canadian pharmacies.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id. }}}{\insrsid157761\charrsid15956527   Phase III\rquote s purpose is to work with the federal Department of HHS, as well as federal officials, to eliminate federal barriers to prescription drugs importation a
t the state level.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id. }}}{\insrsid157761\charrsid15956527 
  Additionally, Minnesota state officials are working with the Minnesota Congressional delegation to acquire statutory authority for Minnesota to import medicine.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.  }}}{\insrsid157761\charrsid15956527   Until this happens, the state believes that the program has been able to
 abide by the FDCA  by parceling out prescription drug orders every ninety days since the FDCA allows for importation of ninety-day supplies for individual use.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 See}{\fs22\insrsid157761\charrsid15610012  Senate Committee, }{\i\fs22\insrsid157761\charrsid15610012 supra }{\fs22\insrsid157761\charrsid15610012 note 120, at 1.}}}{\insrsid157761\charrsid15956527 
  However this may not be the case if the program is importing }{\i\insrsid157761\charrsid15956527 approved}{\insrsid157761\charrsid15956527  prescription drugs from abroad, an act which is not allowed by the personal importation policy.}{
\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 See }{\fs22\insrsid157761\charrsid15610012 Feder, }{\i\fs22\insrsid157761\charrsid15610012 supra}{
\fs22\insrsid157761\charrsid15610012  note}{\i\fs22\insrsid157761\charrsid15610012  }{\fs22\insrsid157761\charrsid15610012 59, at CRS-5.}}}{\insrsid157761\charrsid11742280 
\par }\pard \ql \li0\ri0\nowidctlpar\tx560\tx1120\tx1680\tx2240\tx2800\tx3360\tx3920\tx4480\tx5040\tx5600\tx6160\tx6720\faauto\rin0\lin0\itap0\pararsid157761 {\f4\insrsid157761\charrsid15956527 
\par }{\b\insrsid157761\charrsid6050105 \tab G.  Maryland
\par 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid15956527 \tab 
In Maryland, Montgomery County Executive, Douglas Duncan, wrote a letter to Secretary (HHS) Leavitt requesting a waiver under the MMA}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Refers to the MMA\rquote 
s retention of the requirement, originally included in MEDSA, that only allows for importation of prescription drugs if certified by the Secretary of HHS.}}}{\insrsid157761\charrsid15956527  to allow Montgomery County res
idents and its government employees to import prescription drugs.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012 
 Randy W. Lutter, U.S. Dept. of Health and Human Services Acting Associate Commissioner for Policy and Planning Response to County Executive Douglas Duncan\rquote s Request for Waiver of MMA Prohibition on Prescription Drug Importation, }{
\i\fs22\insrsid157761\charrsid15610012 available }{\i\fs22\insrsid157761\charrsid1665427 at}{\fs22\insrsid157761\charrsid15610012  }{\field\flddirty{\*\fldinst {\fs22\insrsid157761\charrsid15610012 
 HYPERLINK "http://www.fda.gov/oc/opacom/hottopics/importdrugs/duncan110805.html" }{\f360\fs22\insrsid157761\charrsid15610012 {\*\datafield 
00d0c9ea79f9bace118c8200aa004ba90b02000000170000004500000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f006f0063002f006f007000610063006f006d002f0068006f00740074006f0070006900630073002f0069006d0070006f00720074006400720075006700
73002f00640075006e00630061006e003100310030003800300035002e00680074006d006c000000e0c9ea79f9bace118c8200aa004ba90b8a00000068007400740070003a002f002f007700770077002e006600640061002e0067006f0076002f006f0063002f006f007000610063006f006d002f0068006f00740074006f
0070006900630073002f0069006d0070006f0072007400640072007500670073002f00640075006e00630061006e003100310030003800300035002e00680074006d006c000000}}}{\fldrslt {\fs22\insrsid157761\charrsid15610012 
http://www.fda.gov/oc/opacom/hottopics/importdrugs/duncan110805.html}}}{\fs22\insrsid157761\charrsid15610012  (Nov. 8, 2005).}}}{\insrsid157761\charrsid15956527 
  Describing the safety risks associated with the importation of prescription drugs from foreign countries as well as the illegality of importing prescription drugs except under narrow circumstances, the Department of HHS rejected his request.}{
\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\i\fs22\insrsid157761\charrsid15610012  Id.}}}{\insrsid157761\charrsid15956527   Additionally, the county\rquote 
s formal request to establish a pilot program to import drugs from Canada was rejected by the FDA.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 See}{\fs22\insrsid157761\charrsid15610012  Chris Emery, }{
\i\fs22\insrsid157761\charrsid15610012 Duncan Sues Bush Administration Over Drug Imports}{\fs22\insrsid157761\charrsid15610012 , }{\scaps\fs22\insrsid157761\charrsid15610012 Maryland Newsline, }{\fs22\insrsid157761\charrsid15610012 
http://www.newsline.umd.edu/justice/duncanlawsuit022306.htm.}}}{\insrsid157761\charrsid15956527  Soon thereafter, February 2006, the county filed a suit against the Bush Ad
ministration claiming that it is fundamentally unfair that people living in Canada pay significantly less than Americans for the same prescription drugs.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.}}}{\insrsid157761\charrsid15956527   The suit is seeking to overturn the FDA\rquote s ruling on the proposed importation program, alleging that 
the FDA applied an uneven standard when it refused to allow Montgomery residents to import drugs.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id.}}}{\insrsid157761\charrsid15956527   Duncan\rquote 
s spokesman stated that municipalities in other states, including Vermont, Illinois and Massachusetts, already openly import drugs, and the FDA has done nothing to stop them.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.  }}}{\insrsid157761\charrsid15956527   
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\f360\fs26\cf1\insrsid157761\charrsid15956527  
\par }{\b\insrsid157761\charrsid15956527 \tab H.  Oregon
\par 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid15956527 \tab In May 2004, Governor Ted Kulongoski\rquote 
s  announced that he was working with the Board of Pharmacy to develop a plan of reimportation.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Press Release, Office of Senator Ted Kulongoski, Governor Calls for Federal Approval o
f Oregon's Plan to Import Prescription Drugs from Canada, (Aug. 19, 2004), http://governor.oregon.gov/Gov/p2004/press_081904.shtml.}}}{\insrsid157761\charrsid15956527   The plan, named the Pioneer Prescription Drug Project, would have allowed co
nsumers to purchase cheaper prescription drugs from Canada through their licensed Oregon pharmacist.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id.}}}{\insrsid157761\charrsid15956527 
  The project contained several measures to ensure drug safety, such as stringent licensing requirements for the Canadian pharmaceutical wholesalers, routine testing of medicines, and establishment of safe labeling, tracking and shipping requirements.}{
\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id. }}}{\insrsid157761\charrsid15956527   However, like its response to other states\rquote  and cities\rquote 
 request for a federal waiver to import prescription drugs from Canada, the Department of HHS denied the Governor\rquote s request.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012 
 Randy W. Lutter, U.S. Dept. of Health and Human Services Acting Associate Commissioner for Policy and Planning Response to Governor Ted Kulongoski\rquote s Request for Federal Waiver to Import Prescription Drugs (Oct. 15, 2005) }{
\i\fs22\insrsid157761\charrsid1665427 available at}{\fs22\insrsid157761\charrsid15610012  http://www.fda.gov/oc/opacom/hottopics/importdrugs/kulongoski101405.html ; }{\i\fs22\insrsid157761\charrsid15610012 see also}{\fs22\insrsid157761\charrsid15610012 
 Press Release, Office of Senator Ted Kulongoski, }{\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012  note 141.}}}{\insrsid157761\charrsid15956527 
   In its October 2005 denial letter to Governor Kulongoski, HHS stated the same reasons for denial that it included in letters of denial to several other governors and mayors, namely the safety risks associated with reimporting prescription drugs.
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid15956527 
\par }{\b\insrsid157761\charrsid15956527 \tab I.  Other States
\par 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid15956527 \tab 
Nevada, Rhode Island and Texas have not designed nor implemented a reimportation program but had proposed or passed legislation authorizing their state or city to license Canadian pharmacies to import prescription drugs
 to their respective states or cities.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012 
 Randy W. Lutter, U.S. Dept. of Health and Human Services Acting Associate Commissioner for Policy and Planning, Letter to Governor Kenny Guinn Regarding Proposed Importation Legislation (May 20, 2005) }{\i\fs22\insrsid157761\charrsid15610012 available }{
\i\fs22\insrsid157761\charrsid1665427 at }{\fs22\insrsid157761\charrsid15610012 http://www.fda.gov/oc/
opacom/hottopics/importdrugs/guinn052005.html; Randy W. Lutter, U.S. Dept. of Health and Human Services Acting Associate Commissioner for Policy and Planning, Letter to AG Patrick C. Lynch Regarding Enacted Importation Legislation (Jan. 28, 2005) }{
\i\fs22\insrsid157761\charrsid1665427 available}{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid1665427 at }{\fs22\insrsid157761\charrsid15610012 
http://www.fda.gov/oc/opacom/hottopics/importdrugs/lynch012805.html; William K. Hubbard,  U.S. Dept. of Health and Human Services Associate Commissioner for Policy and Planning, Letter to Governor Rick Perry Regarding Enacted Importation Legislation (J
an. 28, 2005) }{\i\fs22\insrsid157761\charrsid15610012 available }{\i\fs22\insrsid157761\charrsid1665427 at}{\fs22\insrsid157761\charrsid15610012  http://www.fda.gov/oc/opacom/hottopics/importdrugs/perry061705.html }}}{\insrsid157761\charrsid15956527 
  Each had received letters from the Department of HHS warning them of the FDA\rquote s safety and legal concerns with their proposed or passed legislation.}{\insrsid157761  }{\insrsid157761\charrsid15956527 
 More specifically, the letters informed them that any state law le
galizing imports in contravention of the FDCA would be preempted by federal law and therefore licensing the Canadian pharmacies to import prescription drugs would result in a violation of federal law.}{\cs16\super\insrsid157761\charrsid15956527 \chftn 
{\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012 
 U.S. Food & Drug Administration, Importing Prescription Drugs \endash  Letters to State and Local Officials at http://www.fda.gov/oc/opacom/hottopics/importdrugs.}}}{\insrsid157761\charrsid15956527 
\par \tab Currently five states have introduced legislation seeking to facilitate the importation of prescription drugs.  Below is a table summarizing the legislation. 
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid15956527 
\par 
\par }\trowd \irow0\irowband0\ts24\trgaph108\trleft-108\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 
\trftsWidth1\trftsWidthB3\trautofit1\trpaddl108\trpaddr108\trpaddfl3\trpaddft3\trpaddfb3\trpaddfr3\tbllkborder\tbllkshading\tbllkfont\tbllkcolor\tbllkbestfit\tbllkhdrrows\tbllkhdrcols \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb
\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \clshdng1250\cltxlrtb\clftsWidth3\clwWidth1728\clshdngraw1250 \cellx1620\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\clshdng1250\cltxlrtb\clftsWidth3\clwWidth2520\clshdngraw1250 \cellx4140\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \clshdng1250\cltxlrtb\clftsWidth3\clwWidth4608\clshdngraw1250 \cellx8748
\pard\plain \ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0\pararsid157761\yts24 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid157761\charrsid15956527 Bill\cell Status\cell Description\cell }\pard\plain 
\ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid157761\charrsid15956527 \trowd \irow0\irowband0\ts24\trgaph108\trleft-108\trbrdrt\brdrs\brdrw10 \trbrdrl
\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 
\trftsWidth1\trftsWidthB3\trautofit1\trpaddl108\trpaddr108\trpaddfl3\trpaddft3\trpaddfb3\trpaddfr3\tbllkborder\tbllkshading\tbllkfont\tbllkcolor\tbllkbestfit\tbllkhdrrows\tbllkhdrcols \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb
\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \clshdng1250\cltxlrtb\clftsWidth3\clwWidth1728\clshdngraw1250 \cellx1620\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\clshdng1250\cltxlrtb\clftsWidth3\clwWidth2520\clshdngraw1250 \cellx4140\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \clshdng1250\cltxlrtb\clftsWidth3\clwWidth4608\clshdngraw1250 \cellx8748\row 
}\trowd \irow1\irowband1\ts24\trgaph108\trrh1421\trleft-108\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 
\trftsWidth1\trftsWidthB3\trautofit1\trpaddl108\trpaddr108\trpaddfl3\trpaddft3\trpaddfb3\trpaddfr3\tbllkborder\tbllkshading\tbllkfont\tbllkcolor\tbllkbestfit\tbllkhdrrows\tbllkhdrcols \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb
\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1728\clshdrawnil \cellx1620\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2520\clshdrawnil \cellx4140
\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4608\clshdrawnil \cellx8748\pard\plain 
\ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0\pararsid157761\yts24 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid157761\charrsid15956527 CA H.B. 2877\cell Introduced 2/24/06\tab \tab \tab \tab \cell 
Would create a website to provide options for obtaining prescription drugs at affordable prices.  The site would provide information and links to pharmacies in Canada, the United Kingdom, and Ireland.\cell }\pard\plain 
\ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid157761\charrsid15956527 \trowd \irow1\irowband1\ts24\trgaph108\trrh1421\trleft-108\trbrdrt\brdrs\brdrw10 \trbrdrl
\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 
\trftsWidth1\trftsWidthB3\trautofit1\trpaddl108\trpaddr108\trpaddfl3\trpaddft3\trpaddfb3\trpaddfr3\tbllkborder\tbllkshading\tbllkfont\tbllkcolor\tbllkbestfit\tbllkhdrrows\tbllkhdrcols \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb
\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1728\clshdrawnil \cellx1620\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2520\clshdrawnil \cellx4140
\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4608\clshdrawnil \cellx8748\row }\trowd \irow2\irowband2\ts24\trgaph108\trleft-108\trbrdrt\brdrs\brdrw10 \trbrdrl
\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 
\trftsWidth1\trftsWidthB3\trautofit1\trpaddl108\trpaddr108\trpaddfl3\trpaddft3\trpaddfb3\trpaddfr3\tbllkborder\tbllkshading\tbllkfont\tbllkcolor\tbllkbestfit\tbllkhdrrows\tbllkhdrcols \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb
\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1728\clshdrawnil \cellx1620\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2520\clshdrawnil \cellx4140
\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4608\clshdrawnil \cellx8748\pard\plain 
\ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0\pararsid157761\yts24 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid157761\charrsid15956527 KY H.B. 163 and S.B. 27\cell Introduced 1/3/06\cell 
Would create a program, upon federal approval, that imports only brand-name drugs that are more cost-effective from Canada.  The program would apply to all state agencies, including Medicaid.\cell }\pard\plain 
\ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid157761\charrsid15956527 \trowd \irow2\irowband2\ts24\trgaph108\trleft-108\trbrdrt\brdrs\brdrw10 \trbrdrl
\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 
\trftsWidth1\trftsWidthB3\trautofit1\trpaddl108\trpaddr108\trpaddfl3\trpaddft3\trpaddfb3\trpaddfr3\tbllkborder\tbllkshading\tbllkfont\tbllkcolor\tbllkbestfit\tbllkhdrrows\tbllkhdrcols \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb
\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1728\clshdrawnil \cellx1620\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2520\clshdrawnil \cellx4140
\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4608\clshdrawnil \cellx8748\row }\pard\plain 
\ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0\pararsid157761\yts24 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid157761\charrsid15956527 KY H.B. 709\cell Introduced 2/27/06\cell 
Would authorize a state to issue a memorandum of understanding with the state of Illinois to join the I-SaveRx program.\cell }\pard\plain \ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid157761\charrsid15956527 \trowd \irow3\irowband3\ts24\trgaph108\trleft-108\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 
\trbrdrv\brdrs\brdrw10 \trftsWidth1\trftsWidthB3\trautofit1\trpaddl108\trpaddr108\trpaddfl3\trpaddft3\trpaddfb3\trpaddfr3\tbllkborder\tbllkshading\tbllkfont\tbllkcolor\tbllkbestfit\tbllkhdrrows\tbllkhdrcols \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1728\clshdrawnil \cellx1620\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth2520\clshdrawnil \cellx4140\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4608\clshdrawnil \cellx8748\row }\trowd \irow4\irowband4
\ts24\trgaph108\trleft-108\trkeep\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 
\trftsWidth1\trftsWidthB3\trautofit1\trpaddl108\trpaddr108\trpaddfl3\trpaddft3\trpaddfb3\trpaddfr3\tbllkborder\tbllkshading\tbllkfont\tbllkcolor\tbllkbestfit\tbllkhdrrows\tbllkhdrcols \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb
\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1728\clshdrawnil \cellx1620\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2520\clshdrawnil \cellx4140
\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4608\clshdrawnil \cellx8748\pard\plain 
\ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0\pararsid157761\yts24 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid157761\charrsid15956527 MD H.B. 1510\cell Introduced 2/15/06\cell 
Would authorize the Department of Health and Mental Hygiene to seek approval from CMS to allow the state to use matching funds to operate a program that purchases and imports prescription drugs from Canada.\cell }\pard\plain 
\ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid157761\charrsid15956527 \trowd \irow4\irowband4\ts24\trgaph108\trleft-108\trkeep\trbrdrt\brdrs\brdrw10 \trbrdrl
\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 
\trftsWidth1\trftsWidthB3\trautofit1\trpaddl108\trpaddr108\trpaddfl3\trpaddft3\trpaddfb3\trpaddfr3\tbllkborder\tbllkshading\tbllkfont\tbllkcolor\tbllkbestfit\tbllkhdrrows\tbllkhdrcols \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb
\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1728\clshdrawnil \cellx1620\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2520\clshdrawnil \cellx4140
\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4608\clshdrawnil \cellx8748\row }\trowd \irow5\irowband5\ts24\trgaph108\trleft-108\trbrdrt\brdrs\brdrw10 \trbrdrl
\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 
\trftsWidth1\trftsWidthB3\trautofit1\trpaddl108\trpaddr108\trpaddfl3\trpaddft3\trpaddfb3\trpaddfr3\tbllkborder\tbllkshading\tbllkfont\tbllkcolor\tbllkbestfit\tbllkhdrrows\tbllkhdrcols \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb
\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1728\clshdrawnil \cellx1620\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2520\clshdrawnil \cellx4140
\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4608\clshdrawnil \cellx8748\pard\plain 
\ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0\pararsid157761\yts24 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid157761\charrsid15956527 MD S.B. 568\cell Introduced 2/3/06\cell 
Would authorize the creation of a Canadian mail-order plan for the purchase and importation of prescription drugs.  The plan would apply to all state-sponsored prescription drugs programs including Medicaid and pharmaceutical assistance programs.  \cell 
}\pard\plain \ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid157761\charrsid15956527 \trowd \irow5\irowband5\ts24\trgaph108\trleft-108\trbrdrt\brdrs\brdrw10 
\trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 
\trftsWidth1\trftsWidthB3\trautofit1\trpaddl108\trpaddr108\trpaddfl3\trpaddft3\trpaddfb3\trpaddfr3\tbllkborder\tbllkshading\tbllkfont\tbllkcolor\tbllkbestfit\tbllkhdrrows\tbllkhdrcols \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb
\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1728\clshdrawnil \cellx1620\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2520\clshdrawnil \cellx4140
\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4608\clshdrawnil \cellx8748\row }\pard\plain 
\ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0\pararsid157761\yts24 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid157761\charrsid15956527 OK. H.B. 2844\cell Passed House 3/20/06\cell The \'93
Drug Reimportation Act\'94 would allow the Board of Pharmacy to designate at least one but no more than ten Canadian pharmacies as having passed inspection for shipping, mailing and delivering prescription drugs order to state residents.  \cell 
}\pard\plain \ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid157761\charrsid15956527 \trowd \irow6\irowband6\ts24\trgaph108\trleft-108\trbrdrt\brdrs\brdrw10 
\trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 
\trftsWidth1\trftsWidthB3\trautofit1\trpaddl108\trpaddr108\trpaddfl3\trpaddft3\trpaddfb3\trpaddfr3\tbllkborder\tbllkshading\tbllkfont\tbllkcolor\tbllkbestfit\tbllkhdrrows\tbllkhdrcols \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb
\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1728\clshdrawnil \cellx1620\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2520\clshdrawnil \cellx4140
\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4608\clshdrawnil \cellx8748\row }\pard\plain 
\ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0\pararsid157761\yts24 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid157761\charrsid15956527 OK S.B. 1434\cell Passed Senate \tab 3/7/06\cell The \'93
Drug Reimportation Act\'94 would allow licensed pharmacies to procure prescription drugs from certified Canadian pharmacies for dispensing in the state.\cell }\pard\plain \ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid157761\charrsid15956527 \trowd \irow7\irowband7\ts24\trgaph108\trleft-108\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 
\trbrdrv\brdrs\brdrw10 \trftsWidth1\trftsWidthB3\trautofit1\trpaddl108\trpaddr108\trpaddfl3\trpaddft3\trpaddfb3\trpaddfr3\tbllkborder\tbllkshading\tbllkfont\tbllkcolor\tbllkbestfit\tbllkhdrrows\tbllkhdrcols \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl
\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1728\clshdrawnil \cellx1620\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 
\cltxlrtb\clftsWidth3\clwWidth2520\clshdrawnil \cellx4140\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4608\clshdrawnil \cellx8748\row }\pard\plain 
\ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0\pararsid157761\yts24 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid157761\charrsid15956527 VA H.B. 388\cell Introduced 1/11/06\cell Would create a
 memorandum of understanding to enter the I-SaveRx program.\cell }\pard\plain \ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid157761\charrsid15956527 
\trowd \irow8\irowband8\lastrow \ts24\trgaph108\trleft-108\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 
\trftsWidth1\trftsWidthB3\trautofit1\trpaddl108\trpaddr108\trpaddfl3\trpaddft3\trpaddfb3\trpaddfr3\tbllkborder\tbllkshading\tbllkfont\tbllkcolor\tbllkbestfit\tbllkhdrrows\tbllkhdrcols \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb
\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1728\clshdrawnil \cellx1620\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2520\clshdrawnil \cellx4140
\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth4608\clshdrawnil \cellx8748\row }\pard 
\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid10628549 \chftn }{\fs22\insrsid157761\charrsid10628549  Seay, }{\i\fs22\insrsid157761\charrsid10628549 supra}{\fs22\insrsid157761\charrsid10628549  note 80.}}}
{\insrsid157761\charrsid15956527 
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid15956527 
\par \tab }{\b\insrsid157761\charrsid15956527 J.  Legality of the States\rquote  Responses
\par }{\b\insrsid157761\charrsid16385524 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\b\insrsid157761\charrsid16385524 \tab }{\insrsid157761\charrsid16385524 
Considering the FDCA explicitly makes importation illegal, except by the original manufacturer of the prescription drug, the states\rquote  response via legis
lation or importation/reimportation program begs the question, is their action legal?  According to the FDA, the answer is a simple, no.  The FDA contends that any effort made by states to enact legislation authorizing prescription drug imports is preempt
ed by federal law.}{\cs16\super\insrsid157761\charrsid16385524 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Jody Feder, }{\i\fs22\insrsid157761\charrsid15610012 Prescription Drug Importation and Internet Sales: A Legal Overview}{\fs22\insrsid157761\charrsid15610012 
, CRS Report for Congress, CRS-13, Updated March 31, 2005 [hereinafter Feder II].}}}{\insrsid157761\charrsid16385524   The FDA has set forth several legal arguments of its position, such as the following,
\par }\pard \qj \li720\ri720\widctlpar\aspalpha\aspnum\faauto\adjustright\rin720\lin720\itap0\pararsid157761 {\cf1\insrsid157761\charrsid16385524 
In the instant matter, Congress set forth a comprehensive importation scheme in the FFDCA that strictly limits the types of prescription drugs that ar
e allowed to be introduced into domestic commerce. For example, the "American goods returned" provision (21 U.S.C. \'a7
 381(d)(1)) was enacted in 1988 as part of the federal Prescription Drug Marketing Act. PL. 100-293 (April 22, 1988). In enacting the law, C
ongress cited the explicit goal of limiting the flow of drugs into the United States from abroad. In section 2 of the bill, Congress found, "[l]large amounts of drugs are being reimported into the United States as American goods returned. These imports ar
e
 a health and safety risk to American consumers because they may have become subpotent or adulterated during foreign handling and shipping." Clearly, Congress enacted section 381(d)(1) and the other import provisions in the FFDCA with the goal of controll
i
ng the types of drugs that could be legally imported into the United States. The federal scheme is comprehensive in that it promulgates national standards that are to be applied equally to all ports of entry, regardless of the states in which they are sit
u
ated. By definition, the scheme cannot allow the individual states to enact laws that erode the federal standards; otherwise, importers could simply circumvent the federal law by routing all their unapproved drugs into the state (or states) that allowed s
u
ch imports. Licensure of Canadian pharmacies by the state of Texas would be inconsistent with the plain objectives of the FFDCA if such licensure authorized those Canadian pharmacies to ship into the United States drugs that violate the provisions of the 
FFDCA.}{\cs16\super\insrsid157761\charrsid16385524  \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Letter from Randy W. Lutter to Governor Perry, }{\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012  note 145.  }}}{
\cf1\insrsid157761\charrsid16385524 
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid16385524 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid16385524 \tab However, preemption of the FDCA\rquote 
s importation provisions has not yet been tested in the courts, and there have been other instances in which other prescription drug provisions in the FDCA have been held not to preempt state law.}{\cs16\super\insrsid157761\charrsid16385524 \chftn 
{\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012 
 Feder II, }{\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012  note 148, at CRS-13 (updated version).}{\i\fs22\insrsid157761\charrsid15610012  }}}{\insrsid157761\charrsid16385524    It is worth no
ting that many of the cases deal with prescription drug labeling, not importation, and state common law claims, not statutory law.}{\cs16\super\insrsid157761\charrsid16385524 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id. }{\fs22\insrsid157761\charrsid15610012 (citing David R. Geiger and Mark D. Rosen, }{\i\fs22\insrsid157761\charrsid15610012 
Rationalizing Product Liability for Prescription Drugs: Implied Preemption, Federal Common Law, and Other Paths to Uniform Pharmaceutical Safety Standards, }{\fs22\insrsid157761\charrsid15610012 45 }{\scaps\fs22\insrsid157761\charrsid15610012 
DePaul L. Rev. }{\fs22\insrsid157761\charrsid15610012 395, 408 (1996). }{\i\fs22\insrsid157761\charrsid15610012  }}}{\insrsid157761\charrsid16385524 
  Despite the uncertainly surrounding this issue, the agency has warned a handful of states that they could be subject to lawsuits for injuries to consumers who relied on the state\rquote s endorsement when purchasing prescription drugs from Canada.}{
\cs16\super\insrsid157761\charrsid16385524 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id. }{\fs22\insrsid157761\charrsid15610012 (Some of these states include Texas, Minnesota, Nevada, and Rhode Island).}}
}{\insrsid157761\charrsid16385524 
\par \tab Although the FDA has issued these warnings, it has not yet taken any legal action against state and local government programs that have 
established drug importation programs.  Interestingly, the FDA specifically indicated that it is unlikely to sue the state of Illinois, which has implemented a plan that would allow its citizens to import from certain European countries, despite the agenc
y\rquote s earlier pronouncement that it would refrain from suing states and localities as long as they imported drugs from Canada and not from other countries.}{\cs16\super\insrsid157761\charrsid16385524 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012  at CRS-15 (citing Inside Washington Publishers, }{\i\fs22\insrsid157761\charrsid15610012 FDA Signals Reluctance to Sue Illinois for Importing Drugs}{
\fs22\insrsid157761\charrsid15610012 , FDA }{\scaps\fs22\insrsid157761\charrsid15610012 Week, }{\fs22\insrsid157761\charrsid15610012 Aug. 20, 2004).}}}{\insrsid157761\charrsid16385524 
  Previously the FDA had indicated that it had refrained from suing states and localities because \'93the 
agency wants to first win its case against Rx Depot, giving FDA bargaining power for the more difficult task of taking formal action against state and local governments.\'94}{\cs16\super\insrsid157761\charrsid16385524 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012  (quoting Inside Washington Publishers, }{\i\fs22\insrsid157761\charrsid15610012 FDA to Resolve Rx Depot Suit Before Taking Sides on States, }{
\fs22\insrsid157761\charrsid15610012 FDA }{\scaps\fs22\insrsid157761\charrsid15610012 Week, O}{\fs22\insrsid157761\charrsid15610012 ct. 31, 2003).}}}{\insrsid157761\charrsid16385524  }{\insrsid157761\charrsid15956527 
However, this suit has since been concluded and was a win for the FDA.  Thus it remains to be seen whether the agency will begin to focus its enforcement efforts on these states and localities.
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid15956527 
\par }{\b\scaps\insrsid157761\charrsid7996244 Executive and Judicial Response
\par }{\b\insrsid157761\charrsid11623964 
\par }{\b\insrsid157761\charrsid11742280 \tab I.  United States v. RxDepot
\par 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid15956527 \tab The reimportation debate has also reached the executive and the judiciary, as th
e government attempts to enforce its prohibition against reimportation by taking violators to court.  The most prominent and oft-mentioned case in this area is United States v.  RxDepot.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote 
\pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012 
 United States v. Rx Depot, 290 F. Supp.2d 1238 (2003).}}}{\insrsid157761\charrsid15956527   Before the government filed the case, it issued a warning letter to
 one of the RxDepot stores on March 21, 2003.  In this letter, the FDA informed the defendants that it believed they were violating the FDCA, because they were causing the reimportation of U.S. manufactured prescription drugs, an act that is only permissi
ble by the manufacturer of the drug itself.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id. }{\fs22\insrsid157761\charrsid15610012 at 1243.}}}{\insrsid157761\charrsid15956527 
 The letter also asked them to reply to its claims and threatened \'93legal action without further notice\'94 if the alleged violations were not corrected.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012 
 Michael J. Rosenquist, Comment, }{\i\fs22\insrsid157761\charrsid15610012 U.S. v. RxDepot: The Battle Between Canadian Store-Front Companies, the FDA and Brand-Name Companies}{\fs22\insrsid157761\charrsid15610012 , 9 }{
\scaps\fs22\insrsid157761\charrsid15610012 Marq. Inell. Prop. L. rev.}{\i\scaps\fs22\insrsid157761\charrsid15610012  }{\scaps\fs22\insrsid157761\charrsid15610012 423, 432 (2005).}}}{\insrsid157761\charrsid15956527   The defendants}{
\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  The defendants in the case were, Tx Depot, Inc., Rx of Canada, LLC, Carl Moore \endash  President of RxDepot and David Peoples \endash  
Secretary of RxDepot.    }{\i\fs22\insrsid157761\charrsid15610012 See}{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 RxDepot}{\fs22\insrsid157761\charrsid15610012 , 290 F.Supp.2d at 1243.}}}{
\insrsid157761\charrsid15956527  responded to the FDA\rquote s warning letter and among other things, did not indicate any intention to stop their illegal practices.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid6050105 \chftn }{\fs22\insrsid157761\charrsid6050105  Rosenquist, }{
\i\fs22\insrsid157761\charrsid6050105 supra}{\fs22\insrsid157761\charrsid6050105  note 157, at 432.}}}{\insrsid157761\charrsid15956527 
   A few months later the Department of Justice proceeded to file a suit, on behalf of the FDA, in federal court alleging that the defendants violated the FDCA by causing the 
shipment of unapproved, foreign-manufactured prescription drugs as well as reimporting U.S.-manufactured prescription drugs from Canadian pharmacies to U.S. citizens.  The suit also alleged that the defendants violated a separate provision of the FDCA tha
t makes it illegal to }{\i\insrsid157761\charrsid11742280 cause}{\insrsid157761\charrsid15956527  unapproved new drugs to be imported into the U.S.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 RxDepot}{\fs22\insrsid157761\charrsid15610012 , 290 F.Supp.2d at 1239, 1241.}}}{\insrsid157761\charrsid15956527 
  The compliant asked for an injunction to stop the defendants from importing or reimporting prescription drugs into the U.S.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012  at 1239.}}}{\insrsid157761\charrsid15956527  
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid15956527 \tab The business, RxDepot, assists individuals in purc
hasing prescription medications from pharmacies in Canada.  The process by which individuals purchase these prescriptions is quite straightforward.  First, the consumer fills out a medical history form and other forms provided by RxDepot and then either d
elivers the documents together with the prescription to the RxDepot stores in person or by mail or fax.}{\cs16\super\insrsid157761\charrsid11623964  }{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id. }{\fs22\insrsid157761\charrsid15610012 at 1242.}}}{\insrsid157761\charrsid15956527     RxDepot then transmits this paperwork along with the customer\rquote 
s credit card information or a certified check to a cooperating pharmacy in Canada.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id. }}}{\insrsid157761\charrsid15956527   
Once received, a Canadian doctor rewrites the prescription, a Canadian pharmacy fills it, ships the prescription drugs directly to the U.S. customer, and bills the customer\rquote s credit card.}{\cs16\super\insrsid157761\charrsid15956527 \chftn 
{\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid10628549 \chftn  }{\i\fs22\insrsid157761\charrsid10628549 
Id.}}}{\insrsid157761\charrsid15956527   The defendants make a profit by receiving a ten to twelve percent commission for each sale facilitated for the Canadian pharmacies.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid10628549 \chftn  }{\i\fs22\insrsid157761\charrsid10628549 Id.}{
\cs16\fs22\super\insrsid157761\charrsid10628549  }}}{\insrsid157761\charrsid15956527 
  The process makes it appear obvious that the defendants are engaged in the business of causing importation and reimportion of prescription drugs from Canada into the U.S. and they did not deny this in their answer to the government\rquote s complaint.}{
\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012  at 1241. }}}{\insrsid157761\charrsid15956527 
\par \tab The government\rquote s primary argument was that \'93unapproved prescription drugs and drugs imported from foreign countries by someone other than the U.S. manufacturer do not have the same assurance of saf
ety and efficacy as drugs regulated by the FDA.\'94}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012  }}}{
\insrsid157761\charrsid15956527   However, the defendants stated that there had been no known cases of harm as a result of the business and claimed that the government\rquote s motives were not driven by public safety but rather by pressure from 
pharmaceutical companies.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 See }{\fs22\insrsid157761\charrsid15610012 Rosenquist, }{\i\fs22\insrsid157761\charrsid15610012 supra}{
\fs22\insrsid157761\charrsid15610012  note 157, at 432 (citing Jim Killackey, }{\i\fs22\insrsid157761\charrsid6050105 Judge Hears Drug Import Arguments; Company Attorney Denies Agency\rquote s Claims its Medications are Unsafe}{
\fs22\insrsid157761\charrsid15610012 , }{\scaps\fs22\insrsid157761\charrsid6050105 Daily Oklahoman}{\fs22\insrsid157761\charrsid15610012 , Oct. 9, 2003, at A1).}}}{\insrsid157761\charrsid15956527 
  They also responded by stating that enjoining RxDepot from continuing its business would not only hurt them but also those who are unable to afford prescription drugs at the high U.S. prices.}{\cs16\super\insrsid157761\charrsid15956527 \chftn 
{\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id. }}}{\insrsid157761\charrsid15956527   The court ultimately sided with the government, stating the following, 
\par }\pard \qj \li720\ri1080\widctlpar\aspalpha\aspnum\faauto\adjustright\rin1080\lin720\itap0\pararsid157761 {\insrsid157761\charrsid15956527 
The fact that there are currently no known cases of someone being harmed by a drug received as a result of using RxDepot or that plaintiff is currently unaware of anyone being harmed by prescription medications ordered
 through RxDepot and imported from Canada does not diminish the legitimate safety concerns of the FDA with unregulated commercial reimportation of U.S.-manufactred drugs by someone other than the manufacturer and importation of foreign-manufactured drugs 
not approved by the FDA.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 RxDepot}{\fs22\insrsid157761\charrsid15610012 , 290 F.Supp.2d at 1242.}}}{\insrsid157761\charrsid15956527 
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid15956527 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid15956527 
Although the court acknowledged that the high cost of prescription drugs in the U.S. make it difficult for some citizens to purchase needed medications and that individual customers believe they benefit from the low prices offered
 by the defendants, it held that the defendants were nevertheless committing an illegal act determined by Congress to harm the public interest.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012  at 1244.}}}{\insrsid157761\charrsid15956527   Moreover, it expressed that \'93Congress, and not this Court, is the best forum for weighing all of the costs and
 benefits of the national statutory scheme regulating prescription drug importation.\'94}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012  at 1248.}}}{
\insrsid157761\charrsid15956527   Therefore, it granted the government\rquote s motion for a preliminary injunction and essentially shut down the business by preventing the defendants from directly or indirect
ly causing the importation of any article of drug into interstate commerce as well as barring any offering, advertising, or promoting, through any media, including the website, any service that may cause or facilitate the importation of any article of dru
g from any place outside the United States.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012  at 1251.}}}{\insrsid157761\charrsid15956527 
  The court also required the defendants to send a letter to all their customers notifying them that their business is illegal and that the safety, purity, and efficacy of drug products obtained through their business could not be assured.}{
\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id. }}}{\insrsid157761\charrsid15956527 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid15956527 \tab After the court\rquote 
s decision, the defendants immediately filed an Emergency Motion to Stay Order of Preliminary Injunction Pending Appeal.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\fs22\insrsid157761\charrsid6050105 United States v. Rx Depot, Inc}{\fs22\insrsid157761\charrsid15610012 ., 297 F.Supp.2d 1306, 1307.}}}{\insrsid157761\charrsid15956527 
  Their motion was denied, the court finding that there was not a likelihood of success on appeal.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012  at 1310.}}}{
\insrsid157761\charrsid15956527   Subsequently, the parties agreed to, and the court approved a consent decree of permanent injunction.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012 
 United States v. RxDepot, Inc., 2006 U.S. App. LEXIS 4173, at *3 (}{\fs22\insrsid157761\charrsid6050105 10th Cir.}{\fs22\cf6\insrsid157761\charrsid15610012  }{\fs22\insrsid157761\charrsid15610012 Feb. 22, 2006).}}}{\insrsid157761\charrsid15956527 
  The consent decree left to the discretion of the district court the issue of what, if any, equitable relief, would be awarded and the court denied restitution reasoning that the RxDepot customers had not lost money in their transactions.}{
\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012  at *4}}}{\insrsid157761\charrsid15956527 
  Moreover, the court also determined that disgorgement of profits was unavailable under the FDCA as a matter of law because the Act\rquote s express provision of oth
er remedies combined with legislative history created the inference that Congress intended to restrict the courts\rquote  power to order disgorgement.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.}}}{\insrsid157761\charrsid15956527   The government appealed this decision and the Court of Appeals of the 10}{\super\insrsid157761\charrsid11623964 th}{\insrsid157761\charrsid15956527 
 Circuit reversed the district court holding that the FDCA does not contain a clear legislative command or compel a necessary and inescapable inference precluding engorgement.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012  at *24, 25.}}}{\insrsid157761\charrsid15956527   Thus, currently in situations such as the RxDepot case, disgorgement is permitted if it furthers the purpose of the FDCA.}{
\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id. }{\fs22\insrsid157761\charrsid15610012 at *25.}}}{\insrsid157761\charrsid15956527 
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid15956527 
\par 
\par 
\par 
\par }{\b\insrsid157761\charrsid15956527 \tab II.  Vermont v. Leavitt
\par 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\cf1\insrsid157761\charrsid11742280 \tab 
In a more recent case, another federal court reached a similar holding to Rx Depot.  On August 2004, the state of Vermont, along with the Vermont Agency of Administration filed a lawsuit against }{\insrsid157761\charrsid11742280 Michael O. Leavitt, i
n his capacity as Secretary of the United States Department of HHS and Lester M. Crawford, in his capacity as Acting Commissioner of the United States FDA}{\cf1\insrsid157761\charrsid11742280  and sought declaratory and injunctive relief based on FDA
\rquote s denial }{\insrsid157761\charrsid11742280 of Vermont's December 4, 2003 citizen petition requesting FDA's permission to establish a program for the importation of prescription drugs from Canada}{\insrsid157761\charrsid10628549 .}{
\cs16\f359\super\insrsid157761\charrsid10628549 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Federal Court Tosses State\rquote s Suit Seeking Legalization of Plan to Import Cheaper Drugs}{
\fs22\insrsid157761\charrsid15610012  (BNA) Vol. 13, No. 38 at 1233 (Sep. 26, 2005).}}}{\insrsid157761\charrsid10628549  }{\cf1\insrsid157761\charrsid11742280 
  More specifically, Vermont wanted to be granted authority to implement a program that would allow its state employees to have their pr
escription filled from Canadian pharmacies and thus requested the FDA to either issue regulations or commit to exercise its enforcement discretion to allow Vermont to implement its proposed program.}{\cs16\f360\cf1\super\insrsid157761\charrsid11742280 
\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{
\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 See}{\fs22\insrsid157761\charrsid15610012  Vermont v. Leavitt, 405 F. Supp 2d 466, 471 (D. Vt. 2005).}}}{\cf1\insrsid157761\charrsid11742280 
  Vermont argued that its citizens were already traveling
 to Canada to purchase prescription drugs and that in the absence of a regulated program it did not have the opportunity to intervene to minimize health risks associated with importing these prescription drugs.}{
\cs16\f360\cf1\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id. }}}{\cf1\insrsid157761\charrsid11742280   Thus, if its petition were to be granted, t
he FDA would enable Vermont to minimize these risks and ensure a higher level of safety.}{\cs16\f360\cf1\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id.}}}{\cf1\insrsid157761\charrsid11742280   
\par \tab Despite\rquote s Vermont\rquote s attempts to persuade the court that it may be able to create a safe system, in the end, the court dismissed its compliant simply because Vermont was asking the FDA to approve a program that is illegal under the FDCA.
}{\cs16\f360\cf1\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id. }{\fs22\insrsid157761\charrsid15610012 at}{\i\fs22\insrsid157761\charrsid15610012  }{
\fs22\insrsid157761\charrsid15610012 472, 479.}}}{\cf1\insrsid157761\charrsid11742280   Citing the RxDepot case, the court specifically stated that, \'93[T]here is no question that Vermont\rquote 
s proposed program would violate the FDCA.  For example, whenever Vermont assisted in the re-importation of a drug manufactured in the United States, it would violate 21 U.S.C. \'a7 331(t).\'94}{\cs16\cf1\super\insrsid157761\charrsid11742280  \chftn 
{\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id. }{\fs22\insrsid157761\charrsid15610012 at 474}}}{\cf1\insrsid157761\charrsid11742280    Additionally, the court noted that Vermont\rquote 
s plan was likely to violate the packing and labeling requirements of the FDCA.}{\cs16\cf1\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id.  }}}{\cf1\insrsid157761\charrsid11742280 
  Because the issue before the court was one of legality rather than the merit of Vermont\rquote s proposal, it was obligated to rule in favor of the government.}{\cs16\f360\cf1\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012  at 470}}}{\cf1\insrsid157761\charrsid11742280 
\par \tab Vermont also claimed that its proposed program was authorized under the MMA as the MMA instructs the FDA to promptly establish regulations to provide for the importation of prescription drugs from Canada into the United States.}{
\cs16\cf1\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id. }{\fs22\insrsid157761\charrsid15610012 at 471}}}{\cf1\insrsid157761\charrsid11742280 
  The court, however, discredited its claim by stating that the referred to provision only becomes effective if the Secretary of Health and Human Serv
ices first certifies to Congress that importation is safe and cost-effective, something the Secretary had not yet done.}{\cs16\cf1\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012  at 474.}}}{\f360\fs26\cf1\insrsid157761\charrsid6898557 
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid15956527 
\par }{\b\cf1\insrsid157761\charrsid11742280 \tab III.  Recent Cases
\par 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\cf1\insrsid157761\charrsid11742280 \tab 
The FDA has continued to take enforcement action against what it believes to be violations of the FDCA.  In November 2004, the U.S. Attorney\rquote 
s Office in the Southern District of New York, on behalf of the FDA, filed a civil suit complaint against Canada Care Drugs, Inc. (\'93Canada Care\'94) for the illegal importation of prescription drugs into the U.S.}{
\cs16\f360\cf1\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Press Release, Food and Drug Administration, FDA Takes Action Against Company for Illegal Importation of Unapproved, Potential Unsafe Drugs (Dec. 4, 2004) }{
\i\fs22\insrsid157761\charrsid15610012 available at}{\fs22\insrsid157761\charrsid15610012  http://www.fda.gov/bbs/topics/news/2004/NEW01142.html.  }}}{\cf1\insrsid157761\charrsid11742280   Canada Care was
 previously affiliated with RxDepot but severed its relationship with the company following the preliminary injunction order against Rx Depot and its affiliates.}{\cs16\f360\cf1\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.}}}{\cf1\insrsid157761\charrsid11742280   However, according to the complaint, it continued to illegally import prescription drugs.}{\cs16\f360\cf1\super\insrsid157761\charrsid11742280 \chftn {\footnote 
\pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id. }}}{\cf1\insrsid157761\charrsid11742280   Based on two undercover purchases made by the FDA, the complaint alleged that Canada Care\rquote 
s operations resulted in importation of products that pose a risk to the public health.}{\cs16\f360\cf1\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id. }}}{\cf1\insrsid157761\charrsid11742280 
  First, the FDA received unapproved drugs despite ordering an FDA-approved version and second t}{\insrsid157761\charrsid11742280 
he manner in which the prescription drugs shipment was sent by the foreign pharmacy posed a potentially serious health threat to the patients who received it.}{\cs16\f359\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id. }}}{\insrsid157761\charrsid11742280   The FDA sought to enjoin Canada Care from directly or indirectly importing or
 causing the importation of U.S.-manufactured and unapproved, foreign-manufactured prescription drugs into the U.S. in violation of the FDCA.}{\cs16\f359\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.}}}{\insrsid157761\charrsid11742280  Additionally, it sought preliminary injunctive relief and monetary relief in the form of restitution, disgorgement, or both.}{\cs16\f359\super\insrsid157761\charrsid11742280 
\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{
\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id.}}}{\insrsid157761\charrsid11742280 
  On March 9, 2006 the court held for the government and ordered Canada Care to stop importing prescription drugs and to forfeit $4,000 in profit.}{\cs16\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Court Halts Co. Importing Drugs From Canada}{\fs22\insrsid157761\charrsid15610012 , }{\scaps\fs22\insrsid157761\charrsid15610012 The Mercury News}{\fs22\insrsid157761\charrsid15610012 , Mar.31, 2006 }{
\i\fs22\insrsid157761\charrsid6050105 at}{\fs22\insrsid157761\charrsid15610012  http://www.mercurynews.com/mld/mercurynews/living/health/14235596.htm.}}}{\insrsid157761\charrsid11742280   }{\insrsid157761\charrsid11742280 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\f359\fs25\insrsid157761\charrsid11742280 \tab }{\insrsid157761\charrsid11742280 
A more recently filed case is quite different from the aforementioned cases, as it involves i
ndividuals suing the government regarding the FDCA rather than the government suing for violations of the FDCA.  The suit, filed on March 31, 2005, involves a couple claiming that the statutory provisions of the FDCA, which restrict their ability to reimp
ort prescription drugs, violated their Constitutional substantive due process rights.}{\cs16\f359\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  2005 U.S. Dist. LEXIS 5710 at *1 (D.D.C. Mar. 31, 2005); see also}{
\f360\fs22\cf1\insrsid157761\charrsid15610012  }{\fs22\insrsid157761\charrsid15610012 Randy W. Lutter, U.S. Dept. of Health and Human Services Associate Commissioner for Policy and Planning Response to Washington State Board of Pharmacy Director\rquote 
s letter to Secretary Leavitt requesting a waiver under (MMA) to allow licensure of Canadian pharmacies and foreign wholesalers by the Washington Board of Pharmacy}{\f360\fs22\cf1\insrsid157761\charrsid15610012 .}{\fs22\insrsid157761\charrsid15610012 
 (Oct. 17, 2006) }{\i\fs22\insrsid157761\charrsid6050105 at}{\fs22\insrsid157761\charrsid15610012  http://www.fda.gov/oc/opacom/hottopics/importdrugs/saxe031706.html. }}}{\insrsid157761\charrsid11742280 
  The United States District Court for the District of Columbia, however, did not agree, finding that the right to purchase prescription drugs from a preferred source or a
t a preferred price was not a fundamental right and that the FDA's interest in ensuring the safety of prescription medications is a legitimate governmental interest.}{\cs16\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012  at *7-*8.}}}{\insrsid157761\charrsid11742280   It went on to further state that the statutory scheme reasonably furthers the legitimate interest by shielding the public}{
\f359\fs25\insrsid157761  }{\insrsid157761\charrsid11742280 from reimported drugs that may be adulterated or otherwise unsafe.}{\cs16\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012  at *8-*9. }}}{\insrsid157761\charrsid11742280 
  The couple also challenged, as arbitrary, capricious, and contrary to law, the refusal of the Secretary of HHS to issue the certifications to Congress under the MMA that would be necessary to trigger certain waivers of the reimportation ban.}{
\cs16\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012 at *3.}}}{\insrsid157761\charrsid11742280 
  As to this claim, the court simply held that the fact that the Secretary had not made these certifications does not constitute reviewable final agency action.}{\cs16\super\insrsid157761\charrsid11742280 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012  at *9.}}}{\insrsid157761\charrsid11742280 
\par \tab All 
these cases suggest that the courts are willing to uphold the current law.  They are making no attempts to circumvent the importation and reimportation provisions of the FDCA and the MMA through the use of policy rationales.  The courts have taken the pos
ition that they will stand by the government and respect the existing status of the law although acknowledging the difficulties that U.S. citizens are facing in the midst of high prescription drugs prices.  Perhaps the rationale behind the judiciary
\rquote s response to this controversial issue follows the principle of the RxDept court, that the best forum for altering the }{\insrsid157761\charrsid15956527 
national statutory scheme regulating prescription drug importation and reimportation lies with Congress and not with the courts.}{\insrsid157761\charrsid11742280 
\par }\pard \ql \li0\ri0\widctlpar\tx5571\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid11742280 \tab 
\par 
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\b\scaps\insrsid157761\charrsid7996244 The Reimportation Debate
\par }{\b\insrsid157761\charrsid15956527 
\par I.  Safety
\par 
\par }{\b\insrsid157761\charrsid6050105 A.  Against Reimportation\tab 
\par 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid15956527 \tab 
Within the reimportation debate, safety is typically the core argument raised by opponents of reimportation. The primary opponents are the FDA and pharmaceutical companies whose interests are generally
 expressed through the Pharmaceutical Research and Manufacturers of America (PhRMA).}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  PhRMA represents the country\rquote s leading research-based pharmaceut
ical companies in the United States.}}}{\insrsid157761\charrsid15956527   While PhRMA claims that their opposition to reimportation emanates from safety and quality concerns that mirror the FDA\rquote s concerns, others posit that the real reason for
 opposition is a concern that reimportation will decrease their profits.  The FDA is an obvious opponent, as it is the federal agency responsible for ensuring that drugs are safe and effective for consumer use.  With regard to reimportation, the FDA, on i
ts website, actually states that safety is its main concern.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 See }{\fs22\insrsid157761\charrsid15610012 
U.S. Food and Drug Administration, Importing Prescription Drugs, http://www.fda.gov/oc/opacom/hottopics/importdrugs/default.htm.}}}{\insrsid157761\charrsid15956527 
 Its objections to reimportation stem from the fact that while drugs manufactured and sold to consumers in the United States are subject to stringent requirements before gaining FDA approval, once
 a drug is exported for sale to another country, it can no longer be monitored by U.S. regulators.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Michelle Meadows, }{\i\fs22\insrsid157761\charrsid15610012 Imported Drugs Raise Safety Concerns}{
\fs22\insrsid157761\charrsid15610012 , }{\scaps\fs22\insrsid157761\charrsid6050105 FDA Consumer Magazine}{\fs22\insrsid157761\charrsid15610012 , Vol. 36, No. 5, (Sept.-Oct. 2002) available at http://www.fda.gov/fdac/features/2002/502_import.html}}}{
\insrsid157761\charrsid15956527  As a result, the FDA cannot ensure a reimported drug\rquote s quality or its safety.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 See id.}}}{\insrsid157761\charrsid15956527 
\par \tab Opponents of reimportation present the following as potential health risks associated with reimporting prescription drugs:
\par {\listtext\pard\plain\f3\insrsid157761\charrsid15956527 \loch\af3\dbch\af0\hich\f3 \'b7\tab}}\pard \qj \fi-360\li1440\ri990\widctlpar\jclisttab\tx1440\tx7560\tx7650\aspalpha\aspnum\faauto\ls11\adjustright\rin990\lin1440\itap0\pararsid157761 {
\insrsid157761\charrsid15956527 Counterfeit Potential \endash  Reimported prescription drugs that bear the name of a U.S.-approved product may, in fact, be counterfeit versions that are unsafe or even completely ineffective; 
\par {\listtext\pard\plain\f3\insrsid157761\charrsid15956527 \loch\af3\dbch\af0\hich\f3 \'b7\tab}Decreased Quality \endash  Prescriptions drugs bought outside the United States may be old or improperly stored, thus compromising their quality; 
\par {\listtext\pard\plain\f3\insrsid157761\charrsid15956527 \loch\af3\dbch\af0\hich\f3 \'b7\tab}Risks of Unsupervised Use - Some medications are unsafe when taken without adequate medical supervision. An individual may need a medical 
evaluation to ensure that the medication is appropriate for their condition or alternatively, an individual may require medical checkups to make sure that he or she is taking the drug properly as well as not having unexpected or life-threatening side effe
cts; 
\par {\listtext\pard\plain\f3\insrsid157761\charrsid15956527 \loch\af3\dbch\af0\hich\f3 \'b7\tab}
Labeling and Language Issues - The medication's label, including instructions for use and possible side effects, may be in a language that the buyer is unable to understand given that it was bought abroad.}{\cs16\super\insrsid157761\charrsid15956527 
\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{
\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 See }{\fs22\insrsid157761\charrsid15610012 Center for Drug Evaluation and Research \endash  U.S. Food and Drug Administration, }{\i\fs22\insrsid157761\charrsid15610012 
Things You Should Know About Purchasing Medicines from Outside the U.S.}{\fs22\insrsid157761\charrsid15610012 , http://www.fda.gov/cder/consumerinfo/border.html; }{\i\fs22\insrsid157761\charrsid15610012 see also }{\fs22\insrsid157761\charrsid15610012 
Center for Drug Evaluation and Research\endash  U.S. Food and Drug Administration, }{\i\fs22\insrsid157761\charrsid15610012 Looks Can Be Deceiving: The Risks of Buying Medicines From Across the Border or Around the World, }{
\fs22\insrsid157761\charrsid15610012 http://www.fda.gov/cder/consumerinfo/border_article.htm.}}}{\insrsid157761\charrsid15956527  
\par }\pard \qj \li1080\ri990\widctlpar\tx7560\tx7650\aspalpha\aspnum\faauto\adjustright\rin990\lin1080\itap0\pararsid157761 {\insrsid157761\charrsid15956527 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid15956527 \tab As stated more succinctly in a Congressional document on the issue, \'93
[T]he clear and present danger to the public health from reimported pharmaceuticacls is the threat that subpotent, superpotent, impotent or even toxic substances labeled as U.S.-produced drugs will enter the distribution.\'94}{
\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\scaps\fs22\insrsid157761\charrsid15610012 Uncertain Returns:  The Mutlimillion Dollar Market in Reimported Pharmaceuticals, 99}{
\scaps\fs22\super\insrsid157761\charrsid15610012 th}{\scaps\fs22\insrsid157761\charrsid15610012  Cong., 2}{\scaps\fs22\super\insrsid157761\charrsid15610012 nd}{\scaps\fs22\insrsid157761\charrsid15610012  Sess. 23}{\fs22\insrsid157761\charrsid15610012 
 (Comm. Print 1986).  }}}{\insrsid157761\charrsid15956527   Because the current drug distribution system in the U.S. is a closed system, these safety risks are not a significant issue.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote 
\pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 See}{\fs22\insrsid157761\charrsid15610012  William B. Pro, }{\i\fs22\insrsid157761\charrsid6050105 Importation of Prescription Drugs and Risks to Patient Safety}{\fs22\insrsid157761\charrsid15610012 , }{
\scaps\fs22\insrsid157761\charrsid15610012 Cal.W. Int\rquote l. L.J. 105, 114 (2005); }{\i\fs22\insrsid157761\charrsid15610012  see also }{\fs22\insrsid157761\charrsid15610012 Andrisano, }{\i\fs22\insrsid157761\charrsid15610012 supra}{
\fs22\insrsid157761\charrsid15610012  note 72, at 906; }{\i\fs22\insrsid157761\charrsid15610012  See also}{\fs22\insrsid157761\charrsid15610012  Silker, }{\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012  note 21 at 391 (
\'93The currant laws banning prescription drug importation and reimportation\'85seek to keep prescription drugs  within the United States\rquote  regulatory system.  Doing so\'85
ensures the American government can more highly assure the safety, effectiveness, and quality of prescription drugs, and American physicians can track the content and strength of their patients\rquote  prescription drugs.\'94)}}}{
\insrsid157761\charrsid15956527   The closed system, regulated by the FDA, protects Americans from the above-mentioned harms.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Andrisano, }{
\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012  note 72, at 906}}}{\insrsid157761\charrsid15956527   However, because countries from which 
consumers may reimport prescription drugs may not have the same regulations or safeguards for prescription drug distribution, this increases the risk of Americans who purchase drugs abroad from receiving counterfeit or tainted drugs.}{
\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id.  }}}{\insrsid157761\charrsid15956527   Moreover, even if a 
foreign country possesses a safe drug distribution system, once the prescription drugs move across borders the safety concerns emerge because they are not under the monitoring and control of any regulatory agency.}{
\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id. }{\fs22\insrsid157761\charrsid15610012 (citing Marc Kaufman, }{\i\fs22\insrsid157761\charrsid6050105 FDA\rquote 
s Authority Tested Over Drug Imports; At Issue is Whether Agency Will Lose Role in Assessing Safety of Medications}{\fs22\insrsid157761\charrsid15610012 , }{\scaps\fs22\insrsid157761\charrsid6050105 Wash. Post}{\fs22\insrsid157761\charrsid15610012 
, Nov. 9, 2003, at A11.}}}{\insrsid157761\charrsid15956527   It is precisely during this unmonitored 
and uncontrolled period that unscrupulous merchants may have the opportunity to slip unapproved drugs into an otherwise safe distribution system which then would result in unapproved drugs entering the U.S. and thereby pose a risk to American consumers.}{
\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012  at 907.}}}{\insrsid157761\charrsid15956527 
\par \tab 
To buttress their argument, opponents refer to instances in which counterfeit or tainted drugs were imported into the U.S.   For example, during a site visit to John F. Kennedy International Airport in New York City, the task force created to advise Secre
t
ary Tommy Thompson on issues surrounding importation of prescription drugs found packages that were dangerous because they were improperly stored, improperly transported, or possessed what looked to be a normal American label but the medication inside was
 not what it was purported to be.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid6050105 Drug Importation: The Real
ities of Safety and Security: Hearing Before the Comm. on Health, Education, Labor and Pensions, 109th Cong. 5 (2005) [hereinafter Prescription Drug Reimportation Hearings I]}{\insrsid157761\charrsid15956527  }{\fs22\insrsid157761\charrsid15610012 
(Statement of Hon. Richard Carmona, M.D., M.P.H., F.A.C.S., Surgeon General, U.S.
 Public Health Service, Department of Health and Human Services). The MMA required the Secretary of the DHHS to provide a comprehensive study that examines the range of issues associated with the importation of prescription drugs.  As a result, in Februar
y 2004, Secretary Tommy Thompson created the HHS Task Force on Drug Importation to conduct the study.  }{\i\fs22\insrsid157761\charrsid15610012 Id. }}}{\insrsid157761\charrsid15956527   Opponents gain further support from the Department of HHS\rquote 
s study on prescription drug importation which reported that the \'93current system of U.S. drug regulation has been effective in protecting public safety but that Am
erican consumers currently purchasing drugs from overseas are generally doing so at a significant risk.\'94}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 See}{\fs22\insrsid157761\charrsid15610012  Task Force Report on Prescription Drug Importation, xii, Dec. 2004, at http://www.hhs.gov/importtaskforce/Report1220.pdf}}}{\insrsid157761\charrsid15956527 
\par \tab More recently, in light of the 9/11 terrorist attacks, some opponents raise the concern that terrorists may attack the supply on drugs if we were to allow reimportation.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 See}{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Prescription Drug Reimportation Hearings I, supra}{\fs22\insrsid157761\charrsid15610012  note 216, at 35.}}}{
\insrsid157761\charrsid15956527 
  However, Dr. Rost, Vice President of Marketing for Endocrine Care at Pfizer, counters this argument by proferring that being concerned about safety assumes that the drug supply is safe already, which he does not think the U.S. is just yet.}{
\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id. }}}{\insrsid157761\charrsid15956527 
  For example, in the U.S., drugs are shipped in large vats to wholesalers, which are then poured in smaller bulk-sized bottles, and then, pharmacists pour those drugs to the patients, which leaves a lot of entry points for terrorists.}{
\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid10628549 \chftn  }{\i\fs22\insrsid157761\charrsid10628549 Id}}}{\insrsid157761\charrsid15956527   On the othe
r hand, in Europe, drugs are shipped in individual bottles or blisters and no one touches the pills after it leaves the manufacturer, making for a much terrorist-resistant system.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id. }}}{\insrsid157761\charrsid15956527 
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid15956527 
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\b\insrsid157761\charrsid7996244 B.  For Reimportation
\par }{\b\i\insrsid157761\charrsid11742280 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid15956527 \tab Advocates of drug reimportation take on a differen
t perspective of the safety issue.  They believe that not taking a drug is just as dangerous as the risk of taking a reimported drug.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 See S.334: An Approach to Drug Importation, Hearing Before the Committee on Health, Education, Labor, and Pensions, }{\fs22\insrsid157761\charrsid15610012 
109th Cong. 11 (2005) (statement of Senator Stowe) [hereinafter }{\i\fs22\insrsid157761\charrsid15610012 Prescription Drug Reimportation Hearings II}{\fs22\insrsid157761\charrsid15610012 ].}}}{\insrsid157761\charrsid15956527 
  These advocates continually refer to the many anecdotes of patients and the elderly forcing themselves to split their pi
lls in order to make them last longer or to the stories of the sick having to choose between food and drugs, both of which are essential for their survival.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012 
 For example, in a Committee Hearings on Drug Reimportation, Senator Kennedy referred to a }{\i\fs22\insrsid157761\charrsid15610012 Health Affairs}{\fs22\insrsid157761\charrsid15610012 
 (a respected medical journal) article which published a major study showing that over a quarter of American seniors went without needed prescriptions or split pills due to the high costs.  }{\i\fs22\insrsid157761\charrsid15610012 Id.}{
\fs22\insrsid157761\charrsid15610012  at 3 (statement of Senator Kennedy).}}}{\insrsid157761\charrsid15956527   They also argue that the safety issues have been exaggerated because safety measures can be put i
n place which would significantly reduce the risks that are of concern.  Additionally, the FDA has recently come under attack by legislators and the public with accusations that it is providing misleading information to protect pharmaceutical companies fr
o
m reimportation especially considering that the FDA Commissioner Mark McClellan himself noted that due to an agreement of cooperation between the FDA and the Canadian Department of National Health and Welfare that drugs marketed in Canada and the U.S. are
 as safe and efficacious as modern science and technology will permit.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 See }{\fs22\insrsid157761\charrsid15610012 Harris, }{
\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012  note 72 at 235 (citing Tony Pugh, }{\i\fs22\insrsid157761\charrsid6050105 FDA Admits It\rquote s Seen No Bad Drugs from Canada}{\fs22\insrsid157761\charrsid15610012 
, http://timesargus.com/Story/75185.html (Nov. 27,2003) (citing figures that FDA officials cannot name a single American who\rquote s been injured or killed by drugs bought from licensed Canadian pharmacies.).}}}{\insrsid157761\charrsid15956527 
  In Committee hearings on the reimportation issue, Governor Tim Pawlenty stated that, \'93If you go to licensed, established, credible, reputable Canadian pharmacies, there is no evidence,
 I repeat, there is no evidence that as applied to those pharmacies, that the safety concerns exist in any manner.\'94}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Prescription Drug Reimportation Hearings I, supra}{\fs22\insrsid157761\charrsid15610012  note 216, at 18 (statement of Hon. Tim Pawlenty, Governor of the State of Minnesota, St. Paul, MN).}}}{
\insrsid157761\charrsid15956527   Referring to his state\rquote s reimportation program, the Governor further stated that the program has filled 9,000 prescriptions through the pr
ogram and that there has not been a single safety complaint or incident of harm.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012  at 19.}}}{
\insrsid157761\charrsid15956527   In another recent Congressional hearing examining a bill aimed at allowing importation of prescription drugs, Dr. David A. Kessler, a former FDA Commissioner, stated the fol
lowing, suggesting that specific safety and quality measures could be put in place that would assure the safe information of prescription drugs.
\par }\pard \qj \li720\ri1080\widctlpar\aspalpha\aspnum\faauto\adjustright\rin1080\lin720\itap0\pararsid157761 {\insrsid157761\charrsid15956527 We could create provisions that would decrease risks to safety, provisions such as those suggested by S. 334.  
[The] bill would allow FDA to implement safeguards to effectively and efficiently stop dangerous imports that currently reach American consumers.  Would enable FDA to determine where a drug comes from and whether it truly is the drug that seller claims.  
B
y requiring FDA inspection and approval of both the manufacturing source of the drug and the chain of custody of the drug, the act allows consumers and commercial entities to buy prescription drugs from Canada and certain other countries with reasonable a
s
surance that the drugs are safe and effective. S. 334 gives FDA authority to assess the manufacturing source of a drug according to the same standards used for domestic dugs and to ban the importation of any drug it finds inadequate.  [It] gives FDA the a
uthority to inspect and verify the chain of custody of the drugs all the way back to the source of manufacture.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012 
 Prescription Drug Reimportation Hearings II, }{\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012  Note 222 at 53.}}}{\insrsid157761\charrsid15956527  
\par 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid15956527 \tab 
Illinois, another state that has implemented a drug reimportation program, conducted a feasibility study to determine whether state employees
 and retirees could obtain safe and effective prescription drugs by purchasing them from Canadian pharmacies.  The study found that pharmacy practices in specific Canadian provinces were equal to or superior to pharmacy practices in the State of Illinois.
}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Illinois Feasibility Report, }{\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012  note 106, at 4-5.}}}{
\insrsid157761\charrsid15956527   More specifically, the study found that prescription medications dispensed in Canada are mainly in \'93unit of use\'94
 sealed packages, shipped directly from the manufacturer thereby reducing the possibility of counterfeiting, both countries\rquote  method of ensurin
g safety and efficacy of prescription drugs are comparable to Illinois, the U.S. and Canada possess comparable requirements at virtually every level for the warehousing and storage of pharmaceuticals, and that the pharmaceutical manufacturing, storage, di
stribution, and dispensing requirements under Canadian law are substantially equivalent to those under U.S. federal requirements.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.}}}{\insrsid157761\charrsid15956527   This study confirmed to the Illinois governor that its reimportation program would be safe for his residents.  Examples such 
as these cut against many of the reimportation opponents\rquote  arguments that it would be extraordinarily difficult and costly to implement a personal importation regime in a way that would ensure safety and effectiveness of all prescription drugs.}{
\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012  }}}{\insrsid157761\charrsid15956527   These exam
ples provide support to the advocates\rquote  claim that a reimportation program could be designed in a manner that would ensure safety and thereby allow U.S. citizens access to safe, affordable prescription drugs.}{
\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 See}{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Prescription Drug Reimportation Hea
rings I, supra}{\fs22\insrsid157761\charrsid15610012  note 216, at 2.}}}{\insrsid157761\charrsid15956527    As such, they believe that the FDA should sto
p focusing on possible risks of harm and instead focus on designing ways that consumers can reimport prescription drugs safely.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id. }{\fs22\insrsid157761\charrsid15610012 at 18 (statement of Hon. Tim Pawlenty, Governor of the State of Minnesota, St. Paul, MN).}}}{\insrsid157761\charrsid15956527 
  If consumers are reimporting drugs despite its illegality, which they are, then it would be more prudent to create a system th
rough legislation or regulation in which safeguards for reimportation are put into place rather than merely admonishing the practice and in meantime allowing the currently unsafe situation to continue.}{\cs16\super\insrsid157761\charrsid15956527 \chftn 
{\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Prescription Drug Reimportation Hearings II, supra}{\fs22\insrsid157761\charrsid15610012  Note 222 at 8-9 (statement of Senator Dorgan). }}}{\insrsid157761\charrsid15956527  
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid15956527 \tab 
\par }{\b\insrsid157761\charrsid15956527 II.  Why the Necessity for Such High Pharmaceutical Prices?
\par }{\insrsid157761\charrsid15956527 \tab 
\par }{\b\insrsid157761\charrsid7996244 \tab A.  Profits Versus Research & Development
\par }{\b\i\insrsid157761\charrsid11742280 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid15956527 \tab 
The pharmaceutical industry is one of the most profitable industries in the country and continues to be profitable even when there is a large slump in the economy.  For example, in 2002, when the rev
enues for the biggest 500 companies sank by 6 percent and reported profits plunged 66%, the pharmaceutical companies profits sank by a mere 3.5 percent.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012   Ann Harrington, }{
\i\fs22\insrsid157761\charrsid15610012 Honey, I Shrunk the Profits Accounting Made a Bad Year Look a Whole Lot Worse}{\fs22\insrsid157761\charrsid15610012 , }{\scaps\fs22\insrsid157761\charrsid15610012 fortune}{\fs22\insrsid157761\charrsid15610012 
, Apr. 14, 2003, at 199. }}}{\insrsid157761\charrsid15956527   Slicing the data another way, the profits registered by the ten largest pharmaceutical companies were equal to more than half the profits netted by the }{\i\insrsid157761\charrsid15956527 
entire}{\insrsid157761\charrsid15956527  list of Fortune 500 companies \endash  when all losses are subtracted from all gains.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012 ; Public Citizen-2002 Drug Industry Profits: Hefty Pharmaceutical Company Margins Dwarf Other Industries, www.citizen.org/documents/Pharma_Report.pdf.}}}{
\insrsid157761\charrsid15956527   These high profit margins beg the question, are such high prices for prescription drugs necessary?\tab 
\par \tab In response, pharmaceutical companies claim that they need to charge higher prices for prescription drugs to U.S. consumers not out of a desire for higher profits but because they need the money to fund research and development (\'93R&D\'94
).  The pharmaceutical industry asserts that the higher profits have allowed them to be the global engine for pharmaceutical innovation.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Andrisano, }{
\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012  note 72, at 922.}}}{\insrsid157761\charrsid15956527 
  According to an oft-referred to study by the Tufts Center for the Study of Drug Development, the total R&D costs per new drug brought to market in the United States is $802 million.}{\cs16\super\insrsid157761\charrsid15956527  \chftn {\footnote 
\pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012 
 Press Release, Tufts Center for the Study of Drug Development, Backgrounder: How New Drugs Move Through the Development and Approval Process (Nov. 1, 2001) (}{\i\fs22\insrsid157761\charrsid15610012 available at}{\fs22\insrsid157761\charrsid15610012 
 http://csdd.tufts.edu/NewsEvents/RecentNews.asp?newsid=4).}}}{\insrsid157761\charrsid15956527   Two years later the same group announced that the total cost to develop a new drug, including post-approval research is $897 million.}{
\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Press Release, Tufts Center for the Study of Drug Development, Backgrounder: How New Drugs Move Through the Development and Approval Process (May 13, 2003) (}{
\i\fs22\insrsid157761\charrsid15610012 available at}{\fs22\insrsid157761\charrsid15610012  http://csdd.tufts.edu/NewsEvents/RecentNews.asp?newsid=29).}}}{\insrsid157761\charrsid15956527 
  In a more recent source, the average cost per successful launch of a new drugs was estimated to be 1.7 billion.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Jim Gilb
ert, Preston Henke & Ashish Singh, }{\i\fs22\insrsid157761\charrsid15610012 Rebuilding Big Pharma\rquote s Business Model}{\fs22\insrsid157761\charrsid15610012 , }{\scaps\fs22\insrsid157761\charrsid15610012 In Vivo, }{\fs22\insrsid157761\charrsid15610012 
Vol. 21, No. 10, Nov. 2003.  The costs are attributed to declining research and development productivity, rising costs of commercialization, increasing payor influence, and shorter exclusivity periods.  }{\i\fs22\insrsid157761\charrsid15610012 Id. }}}{
\insrsid157761\charrsid15956527   It is because of such high costs associated with new drug innovation that pharmaceutical companies claim they must charge high prices for drugs.  
\par \tab While advocates of reimportation acknowledge that drug innovation is costly, they counter the pharmaceutical companies justification for high drug prices by arguing that the pharmaceutical companies do not bear that entire cost themselves.}{
\cs16\super\insrsid157761\charrsid15956527  \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Michael Moore, }{\i\fs22\insrsid157761\charrsid15610012 \'93Open Wide\'94 (Your Pocketbook That Is!) \endash 
 A call for the Establishment in the United States of a Prescription Drug Price Regulatory Agency, }{\fs22\insrsid157761\charrsid15610012 1 Sw. J. of L. & Trade Am. 149, 156 (1994).}}}{\insrsid157761\charrsid15956527 
  First, in the U.S., the government makes enormous investments into R&D and a large portion of this money goes towards Cooperative Research and Development Agreements which allow the government and drug companies to jointly develop new drugs.}{
\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id.}}}{\insrsid157761\charrsid15956527 
  Based on this, it would appear logical that drugs developed using federal money should be priced lower than d
rugs developed without such support since the pharmaceutical companies have less R&D money to have to recoup; however, a report presented to the U.S. Senate Special Committee on Aging showed that this has not been the case.}{
\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012   The rep
ort showed that for new molecular entity priority drugs approved by the FDA in 1991, those that were developed with federal funding were priced substantially higher than those developed without such funding.  }{\i\fs22\insrsid157761\charrsid15610012 Id. }
{\fs22\insrsid157761\charrsid15610012 at 157.}}}{\insrsid157761\charrsid15956527   Second, not only do pharmaceutical companies receive direct federal funding for R&D, they also receive large tax breaks from the federal government.}{
\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id.}}}{\insrsid157761\charrsid15956527 
  One form of tax breaks they receive is through deductions.  The tax code allows pharmaceutical companies to deduct R&D expenses from their income.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012 
 Peter S. Arno & Michael H. Davis, }{\i\fs22\insrsid157761\charrsid15610012 Why Don\rquote t We Enforce Existing Drug Price Controls?}{\fs22\insrsid157761\charrsid15610012 
, 75 Tul. L. Rev. 631, 638 (2001); Section 174 of the Internal Revenue Code allow a taxpayer \'93to treat research or experimental expenditures which are paid or incurred by him during the taxable year 
in connection with his trade or business as expenses which are not chargeable to capital account. The expenditures so treated shall be allowed as a deduction.\'94  26 U.S.C. \'a7174.}}}{\insrsid157761\charrsid15956527 
  They also receive tax breaks through a variety of tax credits for researching expenses.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Arno & Davis, }{\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012 
 note 244, at 638. }}}{\insrsid157761\charrsid15956527   One of the most substantial credits they receive comes from manufacturing products in Puerto Rico.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012 ; }{\i\fs22\insrsid157761\charrsid15610012 see also}{\fs22\insrsid157761\charrsid15610012  Moore, }{\i\fs22\insrsid157761\charrsid15610012 supra}{
\fs22\insrsid157761\charrsid15610012  note 240, at 158.}}}{\insrsid157761\charrsid15956527   This tax provision, named the Possessions Tax Credit, allows tax credit against business income for goods manufactured in Puerto Rico and other U.S. territories.}
{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Moore, }{\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012  note 240 at 158.}}}{\insrsid157761\charrsid15956527 
  Another tax credit, the Orphan Drug Credit, allows pharmaceutical companies to credit up to fifty percent of certain clinical testing expenses related to the innovation of drugs for rare diseases or conditions.}{
\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  U.S. Food and Drug Administration, Tax Credit for Testing Expenses for Drugs for Rare Diseases or Conditions, http://www.fda.gov/orphan/taxcred.htm.}}}{
\insrsid157761\charrsid15956527   Additionally, there are two other notable tax provisions that have provided pharmaceutical companies with significant tax savings: the Foreign Tax Credit and the General Business Tax Credit.}{
\cs16\super\insrsid157761\charrsid15956527  \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Arno & Davis, }{\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012  note 244, at 638.}}}{\insrsid157761 
  To put the significance of these savings into perspective, an analyst in Business Taxation and Finance informed the Joint Economic Committee that between 1990 and 1996, the aforementioned tax breaks generated $27.9 billion dollars in tax savings fo
r the pharmaceutical industry.}{\cs16\super\insrsid157761 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id. }{\fs22\insrsid157761\charrsid15610012 (citing Memorandum
 from Gary Guenther, Analyst in Business Taxation and Finance, to Joint Economic Committee 1-7 (Dec. 13, 1999)).}}}{\insrsid157761 
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid15956527 \tab 
\par }{\b\insrsid157761\charrsid7996244 \tab B.  Advertising and Lobbying Expenses
\par 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid6050105 \tab 
Advocates for reimportation point to the enormous amounts of money that pharmaceutical companies spend on promotional, advertising, and lobbying expenses as further evidence that th
ese companies are more interested in making a large profit than they are in the innovation of new drugs.}{\cs16\super\insrsid157761\charrsid6050105 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 See generally}{\fs22\insrsid157761\charrsid15610012  Ashchian, }{\i\fs22\insrsid157761\charrsid15610012 supra }{\fs22\insrsid157761\charrsid15610012 note 71, at 330 (\'93
Perhaps the most frequent criticism of the pharmaceutical companies is the high amount of money they spend directly advertising prescription drugs to consumers.\'94)}}}{\insrsid157761\charrsid6050105   They argue that the pharmaceutical companies\rquote 
 claims that higher prices must be charged in order to finance R&D is merely a fa\'e7ade and that in actual
ity American consumers are paying higher prices that result from all the advertising and lobbying expenses that pharmaceutical companies accumulate.  
\par }{\insrsid157761\charrsid15956527 \tab Ever since 1997, when the FDA relaxed its rules on television consumer advertising of prescription drugs, drug companies have been spending enormous amounts of money on advertising.}{
\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 See}{\fs22\insrsid157761\charrsid15610012  Silker, }{\i\fs22\insrsid157761\charrsid15610012 supra }{
\fs22\insrsid157761\charrsid15610012 note 21 at 390 (citing John E. Calfee, Prices, Markets, and Pharmaceutical Revolution 46 (2000)).}}}{\insrsid157761\charrsid15956527 
  From 1996 to 2000 pharmaceutical companies increased their spending on television advertising sevenfold and overall advertising tripled during this time period to nearly 2.5 billion a year.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote 
\pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  CBS News, }{
\i\fs22\insrsid157761\charrsid15610012 Drug Advertising Skyrockets}{\fs22\insrsid157761\charrsid15610012 , (Feb. 13, 2002)  at http://www.cbsnews.com/stories/2002/02/13/health/main329293.shtml}}}{\insrsid157761\charrsid15956527 
  According to Families USA, a consumer health organization, \'93}{\insrsid157761\charrsid13123774 
U.S. drug companies that market the 50 most often prescribed drugs to seniors spent almost two-and-one-half times as much on marketing, advertising, and administration as they spent on research and development (R&D) in 2001.\'94}{
\cs16\super\insrsid157761\charrsid13123774 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012 
 Press Release, Families USA, New 2001 Data Show Big Drug Companies Spent Almost Two-and-a-Half Times as Much on Marketing, Advertising and Administration as They Spent on Research and Development
, http://www.familiesusa.org/resources/newsroom/press-releases/press-release-new-2001-data-show-big-drug-companies-spent-almost-two-and-one-half-times-as-much-on-marketing-advertising-and-administration-as-they-spent-on-research-and-development.html.}}}{
\insrsid157761\charrsid13123774   The report goes on to state that nine pharmaceutical companies that market many of the most popular drugs to seniors spent a total of $45.4 billion on market, advertising and administration while spending onl
y $19.1 billion on R&D.}{\cs16\super\insrsid157761\charrsid13123774 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id.}}}{\insrsid157761\charrsid13123774 
  Statistics such as these confirm for many individuals that pharmaceutical companies are using R&D as a front for charging higher than necessary prices so that they can make higher profits and not to create innovative new drugs.
\par \tab }{\insrsid157761\charrsid15956527 P
harmaceutical companies have also been spending enormous amounts of money on lobbying as well.  In the 2000 presidential election alone, pharmaceutical companies spent more than $20 million on political expenditures and then subsequently contributed $60 m
illion in political donations.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Andrisano, }{\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012  note 72 at 919 (citing David Espo, }{
\i\fs22\insrsid157761\charrsid6050105 Lobbying Strong vs. Prescription Bill}{\fs22\insrsid157761\charrsid15610012 , }{\scaps\fs22\insrsid157761\charrsid6050105 Miami Herald,}{\fs22\insrsid157761\charrsid15610012  July 24, 2003, }{
\i\fs22\insrsid157761\charrsid6050105 available at}{\fs22\insrsid157761\charrsid15610012  http://www.miami.com/miamiherald/6372599.htm.)}}}{\insrsid157761\charrsid15956527 
  Critics of high drug prices suggest that their lobbying efforts are an attempt at making Americans believe that high prices are attributable to R&D when in reality the high costs are the result of the drug industry spending 
its money to influence the legislature enough to prevent it from regulating the pharmaceutical industry.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.; see also}{\fs22\insrsid157761\charrsid15610012  Ashchian, }{\i\fs22\insrsid157761\charrsid15610012 supra }{\fs22\insrsid157761\charrsid15610012 note 71, at 331 (\'93Along with advertising,
 pharmaceutical companies additionally spend a bulk of their money on funding political campaigns, and lobbying efforts that support their ability to raise drug prices and avoid governmental control.\'94)}}}{\insrsid157761\charrsid15956527 
  This allows the industry to keep their grip on the lucrative United States prescription drugs market.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.  }}}{\insrsid157761\charrsid15956527   
\par \tab  So where does reimportation fall into this
 debate around profits and R&D?  American consumers are feeling forced to go abroad in order to buy prescription drugs due to the high prices in the US despite its illegality. When these individual reimport prescription drugs, it decreases profits for pha
rmaceutical companies because drug prices in most countries are regulated}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  With the exception of the United States, alm
ost all other industrialized countries have government set price controls on prescription drugs.  }{\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012  at 915. }}}{\insrsid157761\charrsid15956527 
 which effectively results in an import of foreign price controls.}{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Joseph H. Golec & John A. Vernon, }{\i\fs22\insrsid157761\charrsid15610012 What\rquote 
s at Stake in Pharmaceutical Reimportation: The Costs in terms of Life Years, Lives, and Dollars}{\fs22\insrsid157761\charrsid15610012 , 16 }{\scaps\fs22\insrsid157761\charrsid6050105 J. Law. & Pub. Pol\rquote y}{\fs22\insrsid157761\charrsid15610012 
 135 (2005).}}}{\insrsid157761\charrsid15956527   Because reimportation is currently illegal, the impact of these individuals\rquote  purchasing prescription drugs abroad 
has not been too significant.  Critics of reimportation argue that either if this trend continues to increase, or if reimportation becomes legal, pharmaceutical companies\rquote 
 profitability will fall and consequently their investment in R&D will be reduced as 
well.  As a result, not only will the US have less access to innovative drugs because these companies will have less R&D money, but there will also be reduced access because pharmaceutical companies will have less incentive to endure the hassles and diffi
culties of producing risky innovative drugs if they become less profitable. }{\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Michele Creech, Comment, }{\i\fs22\insrsid157761\charrsid15610012 
Make a Run for the Border: Why the United States Government is Looking to the International Market for Affordable Prescription Drugs}{\fs22\insrsid157761\charrsid15610012 , 15 }{\scaps\fs22\insrsid157761\charrsid6050105 Emory Int\rquote l L. Rev}{
\fs22\insrsid157761\charrsid15610012 . 593, 603 (2001).
\par }{\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012  }}}{\insrsid157761\charrsid15956527 
  On the other hand, pharmaceutical industry critics and reimportation advocates claim that the industry earns more than enough revenues to fund their R&D in the face of reimported drugs and still have an excess of profits.}{
\cs16\super\insrsid157761\charrsid15956527 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Golec & Vernon, }{\i\fs22\insrsid157761\charrsid15610012 supra }{\fs22\insrsid157761\charrsid15610012 note 250, at 136.}}}{\insrsid157761\charrsid15956527 
  The debate appears difficult to resolve because it relies on individual notions of acceptable levels of profits and thus without an objective baseline will most likely continue to be a contentious issue within the reimportation debate.  
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid15956527 \tab 
\par }{\b\insrsid157761\charrsid11742280 III.  Prescription Drug Price Regulation
\par 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761 \tab 
As a corollary to the profits versus R&D issue is the controversy surrounding prescription drug price regulation.  Advocates of reimportation suggest that if the government regulated 
prescription drug prices, as is done in all other developed countries, individuals would not feel compelled to reimport prescription drugs.}{\cs16\super\insrsid157761 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 See}{\fs22\insrsid157761\charrsid15610012  Creech, }{\i\fs22\insrsid157761\charrsid15610012 supra }{\fs22\insrsid157761\charrsid15610012 note 261, at 626-27.}}}{\insrsid157761 
  They argue that if the U.S. government is not willing to implement price controls on the U.S. market, a reimportation measure should be legalized in order to allow American consumers to benefit from international price controls.}{
\cs16\super\insrsid157761 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{
\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012  }}}{\insrsid157761   
\par \tab Price controls in other countries, though not perfect, have proven to be successful at decreasing prices.}{\cs16\super\insrsid157761 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012  at 613}}}{
\insrsid157761   As an example, U.S.\rquote  neighbor
, Canada, has a board (Patented Medicine Prices Review Board) that dictates the maximum price for a new prescription drug entering the Canadian market by ensuring the prices of Canadian pharmaceuticals are no higher than a products mean price in seven ind
ustrialized nations.}{\cs16\super\insrsid157761 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid6050105 \chftn }{\fs22\insrsid157761\charrsid6050105  Andrisano, }{\i\fs22\insrsid157761\charrsid6050105 supra}{\fs22\insrsid157761\charrsid6050105  note 72, at 916; }{\i\fs22\insrsid157761\charrsid6050105 see also}{
\fs22\insrsid157761\charrsid6050105  Creech, }{\i\fs22\insrsid157761\charrsid6050105 supra}{\fs22\insrsid157761\charrsid6050105  note 259, at 615 (\'93The PMPRB arrives at a price based on the philosophy that the price should not be more than t
he average in seven other developed countries.  The prices are allowed to rise and fall with the Canadian Consumer Pricing Index (CCPI); however, pharmaceutical manufacturers cannot exceed the maximum prices established by the PMPRB.\'94)}}}{
\i\insrsid157761   }{\insrsid157761 All pharmaceutical companies selling or importing prescription drugs into Canada are required to abide by the mandated pricing rules if they want to sell their products in Canada.}{\cs16\super\insrsid157761 \chftn 
{\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 See}{\fs22\insrsid157761\charrsid15610012  Ashchian, }{\i\fs22\insrsid157761\charrsid15610012 supra }{\fs22\insrsid157761\charrsid15610012 note 71, at 331.}}}{\insrsid157761 
 The board considers several factors in setting the max price, including manufacturing and marketing costs; however, it explicitly cannot take the cost of R&D into its calculations.}{\cs16\super\insrsid157761 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Andrisano, }{
\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012  note 72, at 916.}}}{\insrsid157761   
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761 \tab Along the same lines, the European nations have also established their own prescription drug price control systems.  France
\rquote s government, which covers its entire population by a national health care and social insurance system, regulates prices directly through reimbursement.}{\cs16\super\insrsid157761 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 See}{\fs22\insrsid157761\charrsid15610012  Creech, }{\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012  note 261, at 616.}}}{\insrsid157761 
   The government must approve the pharmaceutical manufacturer\rquote s price before it will be reimbursed by the country\rquote s social insurance system}{\i\insrsid157761 .}{\cs16\super\insrsid157761\charrsid6050105 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id}{\fs22\insrsid157761\charrsid15610012  at 617.}}}{\i\insrsid157761  }{\insrsid157761 
The government requires pharmaceutical companies to provide detailed data on costs, sales, and investment information and then evaluates the data to establish a reimbursement price.}{\cs16\super\insrsid157761 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.}}}{\insrsid157761   Additionally, if the government\rquote 
s budgets on pharmaceutical spending are exceeded, the pharmaceutical companies must contribute to the deficit through taxes on advertising, sales and extraordinary sales increases.}{\cs16\super\insrsid157761 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012  at 616.}}}{\insrsid157761  
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761 \tab In the United Kingdom, the Pharmaceutical Price Regulation System assur
es reasonable prescription drugs prices by regulating companies\rquote  profits on sales to the country\rquote s National Health Service (NHS) rather than directly regulating prices.}{\cs16\super\insrsid157761 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id. }{\fs22\insrsid157761\charrsid15610012 at 619.}}}{\insrsid157761   The prescription drug manufacturers can dictate the price of a new drug, but are subj
ect to a constraint on their overall rate of return on capital for all products sold to the NHS.}{\cs16\super\insrsid157761 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012 
 (citing Patricia M. Danzon & Li-Wei Chao}{\i\fs22\insrsid157761\charrsid6050105 , Does Regulation Drive Out Competition in Pharmaceutical Markets?}{\fs22\insrsid157761\charrsid15610012 , 43 }{\scaps\fs22\insrsid157761\charrsid6050105 J. Law & Econ}{
\fs22\insrsid157761\charrsid15610012 . 311, 312 (2000).}}}{\insrsid157761   Additionally, if a company wants to increase a product\rquote s price, it must obtain approval from the government.}{\cs16\super\insrsid157761 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.}}}{\insrsid157761   
\par \tab Japan\rquote s regulation system is similar to that of France.  Like France, instead of directly controlling prices, it regulates prices by setting reimbursement prices at the drug\rquote 
s launch by comparing the new product with a similar existing product.}{\cs16\super\insrsid157761 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id. at}{\fs22\insrsid157761\charrsid15610012  618.}}}{
\insrsid157761   The regulation system forces pharmaceutical companies
 to compete by reducing prices below the reimbursement price because the price is typically paid by physicians, which gives physicians incentives to write prescriptions for drugs on which they can make the most personal profit.}{\cs16\super\insrsid157761 
\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{
\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012  }}}{\insrsid157761   As another measure, Japan\rquote 
s government may mandate price cuts if the sales of the prescription drug exceed the expected target sales.}{\cs16\super\insrsid157761 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id.}}}{\insrsid157761 
\par \tab While all these examples suggest that price controls, whether direct or indirect, can be effective, pharmaceutical companies are obviously opposed
 to any form of price controls and raise the oft-used argument that it will decrease funds available for R&D.}{\cs16\super\insrsid157761 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Drabiak, }{\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012 
 note 18 at 151 (citing Patricia M. Danzon, Pharmaceutical Price Regulation: National Policies Versus Global Interests 1-4 (1997).  R&D costs make pharmaceuticals vulnerable 
to aggressive price regulation, and companies would be limited in future innovative R&D. }{\i\fs22\insrsid157761\charrsid15610012 Id.}{\fs22\insrsid157761\charrsid15610012  at 3-4).
\par Pharmaceutical companies have successfully prevented their fears from becoming a reality by using their tremendous influence in politics to make Congress 
unable to make significant progress with any major reform attempting to restructure the pharmaceutical industry through government intervention of price controls.  Creech, }{\i\fs22\insrsid157761\charrsid15610012 supra}{
\fs22\insrsid157761\charrsid15610012  note 261 at 626.}}}{\insrsid157761   The pharmaceutical companies are not alone in their opposition to price controls.  John Calfee}{\cs16\super\insrsid157761 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012 
 Writer for the American Enterprise Institute who studies pharmaceuticals, the Food and Drug Administration, health care policy and advertising. }}}{\insrsid157761  is an opponent to price controls and claims that any sort of price control is \'93
deeply misconceived and could thwart today\rquote s dramatic, but still incipient, advances in biological science and medical practice.\'94}{\cs16\super\insrsid157761 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\scaps\fs22\insrsid157761\charrsid15610012 John Calfee, Prices, Markets and the Pharmaceutical Revolution 1 (2000)..}}}{\insrsid157761   In other words, he believes that price controls will create disincentives for pharmaceutical 
companies to continue to invest in R&D.
\par \tab Despite these claims proponents of price controls counter by arguing that it is unfair for U.S. citizens, alone, to bear all the costs of R&D.  It has been suggested that because the U.S. is the only industrialized 
nation that does not have government set price controls on prescription drugs, Americans are the ones bearing the burden of paying for R&D while the rest of the world gets to reap the benefits.}{\cs16\super\insrsid157761 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Andrisano, }{
\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012  note 72 at 915; }{\i\fs22\insrsid157761\charrsid15610012 see also}{\fs22\insrsid157761\charrsid15610012  Creech }{\i\fs22\insrsid157761\charrsid15610012 supra}{
\fs22\insrsid157761\charrsid15610012  note 261 at 614 (\'93American consumers must pay more for drugs because pharmaceutical manufacturers often balance cheaper prices in foreign markets by raising prices in the U.S.\'94)}}}{\insrsid157761 
  Thus some believe that if reimportation is not legalized, the government should implement price controls in order to make pharmaceuticals more affordable for U.S. citizens.}{\cs16\super\insrsid157761 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Silker, }{
\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012  note 21 at 394.}}}{\insrsid157761 
  These individuals hope that this will compel pharmaceutical companies to renegotiate with price-controlled foreign companies in order to spread costs in a more equitable manner.}{\cs16\super\insrsid157761 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id.}}}{\insrsid157761 
  Some proponents of price controls acknowledge that this form of regulation may disincentivize pharmaceutical companies from investing in R&D; however, they still insist that some form of regulation is necessary as pri
ces become exorbitantly high and believe that a system of price controls could be designed that would strike a balance between maintaining the benefits of the current system while making prices more affordable for consumers.}{\cs16\super\insrsid157761 
\chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{
\fs22\insrsid157761\charrsid15610012  Drabiak, }{\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012  note 18, at 151.}}}{\insrsid157761 \tab  
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761 \tab 
\par 
\par }{\b\scaps\insrsid157761\charrsid7996244 Conclusion:  Any Viable Solutions in Sight?
\par }{\b\insrsid157761 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761 \tab 
Resolving this debate is especially difficult because the arguments both for and against reimportation appear to be valid.  Given the U.S.\rquote s history with unregulated drugs and the deadly effects that can result from a lack of regulatio
n combined with the need to provide incentives for pharmaceutical companies to continue to develop innovative new drugs, it certainly seems logical that permitting reimportation may not really be in the consumers\rquote 
 best interest.  On the other hand, if cons
umers simply can not access necessary drugs due to their high prices, would they not be better off taking the risk that an imported drug may be unsafe rather than a guarantee of ill health due to not taking a prescription drug?  
\par \tab There have been a variety
 of solutions that have been proferred, some incorporating reimportation while others that are alternatives to reimportation.  For those solutions that permit reimportation, the primary aspect of the solution is to place stringent safeguards in place that
 
would ensure that the reimported drugs no longer pose a safety risk.  Some of these suggested safeguards include full chain-of-custody documentation from importers and exporters, adopting and using prescription drug electronic track and trace technology a
t the case and pallet level, and establishment of a Counterfeit Alert network.}{\cs16\super\insrsid157761 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  Safe Importing of Medical Products and Rx Therapies Act, S.2493, 108th Congress (2004).}}}{
\insrsid157761   Additionally, some solutions seek allowing drug reimports but restricting ports of entry, educating consumers about the dangers of reimported drugs, and allowing drug reimports from approved Canadian pharmacies only.}{
\cs16\super\insrsid157761 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{
\fs22\insrsid157761\charrsid15610012  Feder II, }{\i\fs22\insrsid157761\charrsid15610012 supra}{\fs22\insrsid157761\charrsid15610012  note 148, at CRS-39  . }}}{\insrsid157761  
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761 
Solutions that are alternatives to reimportation include, encouraging the development of more generic drugs, negotiating lower drug prices through bulk purchase programs, increasing prescription drug insurance cov
erage and implementing price controls as discussed above.}{\cs16\super\insrsid157761 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{\i\fs22\insrsid157761\charrsid15610012 Id.  }}}{\insrsid157761 
  One such non-reimportation type solution suggests using states as market participants in providing prescription drugs.}{\cs16\super\insrsid157761 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid6050105 \chftn }{\fs22\insrsid157761\charrsid6050105  Ashchian, }{
\i\fs22\insrsid157761\charrsid6050105 supra}{\fs22\insrsid157761\charrsid6050105  note 71, at 334.  }}}{\insrsid157761   The state could take the role of a market participant and use its leverage 
in a transaction with pharmaceutical companies, thereby negotiating a larger discount.}{\cs16\super\insrsid157761 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid6050105 \chftn }{\fs22\insrsid157761\charrsid6050105  }{\i\fs22\insrsid157761\charrsid6050105 Id. }}}{\insrsid157761 
  Another proposal to alleviate the problem of high prices is a rate-of-return regulation.}{\cs16\super\insrsid157761 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid6050105 \chftn }{\fs22\insrsid157761\charrsid6050105  Drabiak, }{\i\fs22\insrsid157761\charrsid6050105 supra}{\fs22\insrsid157761\charrsid6050105 
 note 18, at 155.}}}{\insrsid157761   This type of regulation regulates profits rather than prices.}{\cs16\super\insrsid157761 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid6050105 \chftn }{\fs22\insrsid157761\charrsid6050105  }{\i\fs22\insrsid157761\charrsid6050105 Id. }}}{\insrsid157761   The goals of such a regulation are \'93
to secure the provision of safe and effective medicines\'85at reasonable prices\'85and to promote a strong and profitable pharmaceutical industry\'85capable of such sustained R&D expenditures as should lead to the future availability of new 
and improved medicines.\'94}{\cs16\super\insrsid157761 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid6050105 \chftn }{\fs22\insrsid157761\charrsid6050105  }{\i\fs22\insrsid157761\charrsid6050105 Id. }}}{\insrsid157761 
  Under such a system, each pharmaceutical company negotiates with the government for an allowed total rate-of-return on capital and any excess is repaid either directly or through a price reduction.}{\cs16\super\insrsid157761 \chftn {\footnote 
\pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid157761 \chftn }{\insrsid157761  }{\i\insrsid157761 Id. }}}{\insrsid157761 
  Conversely, any companies that fail to meet their target rate-of-return may apply for a price increase.}{\cs16\super\insrsid157761 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid157761 \chftn }{\insrsid157761  }{\i\insrsid157761 Id.  }}}{\insrsid157761 
  Another interesting solution involves managed-care.  This solution suggests that HMOs and pharmacy benefit management companies that manage drug benefits for HMOs use their leveraging power in negotiating discounts from manufacturers.}{
\cs16\super\insrsid157761 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid157761 \chftn }{\insrsid157761  }{
\i\insrsid157761 Id. }}}{\insrsid157761   However, this solution runs the risk that pharmaceutical companies will not produce sufficient revenues to cover R&D costs as they will be making less of a profit.  The most promising solution invol
ves devising ways to spread the costs of producing innovate new drugs to other countries which are now seen as \'93free-loading\'94
 off of Americans.   Citizens of other countries are protected from high prices by the price controls implemented in their countrie
s.  Perhaps if drug companies began using their own leveraging power, which they must have to some extent as they are the means of access to new drugs, they could break the barrier of price controls in foreign countries or at least negotiate better prices
 so that it could spread the costs of R&D to all purchasers of their drugs.}{\cs16\super\insrsid157761 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid6050105 \chftn }{\fs22\insrsid157761\charrsid6050105  }{\i\fs22\insrsid157761\charrsid6050105 See}{\fs22\insrsid157761\charrsid6050105  }{
\i\fs22\insrsid157761\charrsid6050105 generally }{\fs22\insrsid157761\charrsid6050105 Creech, }{\i\fs22\insrsid157761\charrsid6050105 supra}{\fs22\insrsid157761\charrsid6050105  note 261, at 614, 644 (\'93
American consumers must pay more for drugs because pharmaceutical manufacturers often balance cheaper prices in foreign markets by raising prices in the U.S.\'94); see also Andrisano, }{\i\fs22\insrsid157761\charrsid6050105 supra}{
\fs22\insrsid157761\charrsid6050105  note 72 at 915.}}}{\insrsid157761   
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761 \tab 
Although so many different solutions have been proferred, the fact that none of have been accepted and implemented suggests that none have been able to satisfy all interested pa
rties.  After researching this contentious debate, I have realized that before a solution can be formulated future lawmakers and policy analysts must study the facts and at the least come to an agreement on how studies can be performed and data analyzed i
n
 a manner that is considered legitimate by all parties.  Additionally, from my perspective, the problem is harder to solve because individuals are basing their conclusions on completely different sets of data and from different studies.  As a result, many
 
times it appears that individuals are comparing apples and oranges, which then makes it obvious that they will never come to a compromise.   For example, in a study on disparities of drug countries between the U.S. and other countries, a couple analysts f
o
und that pharmaceutical prices in large developed nations were not consistently lower than those in the U.S.; however, another group of analysts applied similar methods and found that the prices in the large developed nations were between 35 and 48 percen
t lower than U.S. prices.}{\cs16\super\insrsid157761 \chftn {\footnote \pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  John E. Calfee, Mario Villarrel & Elizabeth DuPre, }{\i\fs22\insrsid157761\charrsid15610012 
An Exploratory Analysis  of Pharmaceutical Price Disparities and Their Implications Among Six Developed Nations}{\fs22\insrsid157761\charrsid15610012  8 (AEI-Brookings Joint Center for Regulatory Issues, Working Paper No. 06-07, 2006)}}}{\insrsid157761 
  How could the numbers have been so different?  It is because they used different criteria in determining which drugs to keep in their final data set.  In the first study, John Calfee}{\cs16\super\insrsid157761 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012 
 John Calfee researches researches pharmaceuticals, the Food and Drug Administration and  health care policy}}}{\insrsid157761  found that the analysts included both patente
d and generic prescription drugs prices while in the second study, the analysts dropped all drugs facing generic competition in the U.S.}{\cs16\super\insrsid157761 \chftn {\footnote \pard\plain 
\s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs22\super\insrsid157761\charrsid15610012 \chftn }{\fs22\insrsid157761\charrsid15610012  }{
\i\fs22\insrsid157761\charrsid15610012 Id. }}}{\insrsid157761   Because it has been shown that generic prices are often inflated in other countries, deciding whether to include or d
rop these drugs and their corresponding prices led to drastically different results.  This shows that both proponents and opponents of reimportation can be \'93right\'94
 when the former claims that prescription drug prices are lower abroad and the latter claims the opposite.  It all depends on how \'93prescription drug\'94
 is defined in the studies they are quoting.  Thus in order to come to a solution, all sides of this contentious debate first need to ensure that they are working under the same baseline presumptions 
in order to be able to come to a compromise on more complicated issues.   It is only if all parties are starting from the same point can a viable solution ever hoped to be developed.
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid157761 {\insrsid157761\charrsid2057514 
\par }}