{\rtf1\ansi\ansicpg1252\uc1 \deff0\deflang1033\deflangfe1033{\fonttbl{\f0\froman\fcharset0\fprq2{\*\panose 02020603050405020304}Times New Roman{\*\falt Times New Roman};}{\f66\froman\fcharset238\fprq2 Times New Roman CE{\*\falt Times New Roman};} {\f67\froman\fcharset204\fprq2 Times New Roman Cyr{\*\falt Times New Roman};}{\f69\froman\fcharset161\fprq2 Times New Roman Greek{\*\falt Times New Roman};}{\f70\froman\fcharset162\fprq2 Times New Roman Tur{\*\falt Times New Roman};} {\f71\froman\fcharset177\fprq2 Times New Roman (Hebrew){\*\falt Times New Roman};}{\f72\froman\fcharset178\fprq2 Times New Roman (Arabic){\*\falt Times New Roman};}{\f73\froman\fcharset186\fprq2 Times New Roman Baltic{\*\falt Times New Roman};}} {\colortbl;\red0\green0\blue0;\red0\green0\blue255;\red0\green255\blue255;\red0\green255\blue0;\red255\green0\blue255;\red255\green0\blue0;\red255\green255\blue0;\red255\green255\blue255;\red0\green0\blue128;\red0\green128\blue128;\red0\green128\blue0; \red128\green0\blue128;\red128\green0\blue0;\red128\green128\blue0;\red128\green128\blue128;\red192\green192\blue192;}{\stylesheet{\ql \li0\ri0\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 \snext0 Normal;}{\* \cs10 \additive Default Paragraph Font;}{\*\cs15 \additive footnote reference;}}{\info{\title The Real Thalidomide Baby: }{\author Beth Ann Vida}{\operator Chad and Sarah Ludington}{\creatim\yr2002\mo7\dy5\hr10\min44}{\revtim\yr2002\mo7\dy5\hr10\min44} {\version2}{\edmins1}{\nofpages27}{\nofwords3553}{\nofchars20257}{\*\company Covington & Burling}{\nofcharsws24877}{\vern8269}}\margl1440\margr1440\margt1260\margb1260 \widowctrl\ftnbj\aenddoc\aftnnar\notabind\wraptrsp\transmf\noxlattoyen\expshrtn\noultrlspc\dntblnsbdb\nospaceforul\truncatefontheight\subfontbysize\sprsbsp\wpjst\lytprtmet\hyphcaps0\horzdoc\dghspace120\dgvspace120\dghorigin1701\dgvorigin1984\dghshow0 \dgvshow3\jcompress\viewkind1\viewscale100\splytwnine\ftnlytwnine\htmautsp\nolnhtadjtbl\useltbaln\alntblind\lytcalctblwd\lyttblrtgr \fet0\sectd \linex0\headery1260\footery1260\sectdefaultcl {\*\pnseclvl1\pnucrm\pnstart1\pnindent720\pnhang{\pntxta .}} {\*\pnseclvl2\pnucltr\pnstart1\pnindent720\pnhang{\pntxta .}}{\*\pnseclvl3\pndec\pnstart1\pnindent720\pnhang{\pntxta .}}{\*\pnseclvl4\pnlcltr\pnstart1\pnindent720\pnhang{\pntxta )}}{\*\pnseclvl5\pndec\pnstart1\pnindent720\pnhang{\pntxtb (}{\pntxta )}} {\*\pnseclvl6\pnlcltr\pnstart1\pnindent720\pnhang{\pntxtb (}{\pntxta )}}{\*\pnseclvl7\pnlcrm\pnstart1\pnindent720\pnhang{\pntxtb (}{\pntxta )}}{\*\pnseclvl8\pnlcltr\pnstart1\pnindent720\pnhang{\pntxtb (}{\pntxta )}}{\*\pnseclvl9 \pnlcrm\pnstart1\pnindent720\pnhang{\pntxtb (}{\pntxta )}}\pard\plain \ql \li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\b\fs24 \par \par \par \par \par }\pard \qc \li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 {\b\fs36 The Real Thalidomide Baby:}{\b\fs24 \par }\pard \ql \li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 {\b\fs24 \par }\pard \qc \li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 {\b\fs30 The Evolution Of The FDA In The Shadow of Thalidomide, 1960 - 1997}{\b\fs24 \par }\pard \ql \li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 {\b\fs24 \par \par \par \par \par \par \par \par \par \par \par }\pard \ql \fi5760\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 {\b\fs24 Scott P. Glauberman \par Food and Drug Law, Winter 1997 \par Professor Peter Barton Hutt \par \sect }\sectd \linex0\headery1260\footery1260\sectdefaultcl {\footer \pard\plain \ql \li0\ri0\sl-240\slmult0\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \par }\pard \qc \li0\ri0\nowidctlpar\pvpara\posx0\posy0\absw9361\nowrap\faauto\rin0\lin0\itap0 {\fs24 Page }{\field{\*\fldinst {\fs24 PAGE }}{\fldrslt {\fs24\lang1024\langfe1024\noproof 27}}}{\fs24 \par }\pard \ql \li0\ri0\nowidctlpar\faauto\rin0\lin0\itap0 {\fs24 \par }}\pard\plain \ql \li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\b\fs24 Introduction}{\fs24 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 {\fs24 It is no exaggeration to state that the story of thalidomide is the story of the modern FDA. Thalidomide became history\rquote s most infamous drug in the late 1950s and early 1960s when it caused serious birth defects in thousands of newborns. Congress, reacting to the tragedy, quickly passed amendments to the Food, Drug, and Cosmetic Act which dramatically toughened the FDA \rquote s approach to new drugs. But the pendulum has recently begun to swing the other way: aggravation with the FDA\rquote s time-consuming and expensive approval process for drugs like thalidomide has led to expedited approval procedures and calls for reform. \par This paper is intended to document the over thirty-year relationship between the FDA and thalidomide and to describe in some detail the new uses for that drug. The paper\rquote s secondary goal is to de monstrate the power and versatility of food and drug law online research; every source cited herein, with the exception of the course materials, is available to anyone with access to Westlaw and the World Wide Web.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 In order to illustrate this dimension of the paper, I will provide online \'93addresses\'94 as part of the citation form even where the Bluebook does not require them.}}}{\fs24 \par }\pard \ql \li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 {\fs24 \par }{\b\fs24 The Original Uses Of Thalidomide}{\fs24 \par \sect }\sectd \sbknone\linex0\headery1260\footery1260\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 Thali domide, one of the most notorious drugs in the world, was first developed and sold in Europe in the 1950s as a tranquilizer.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 Brett Lowell, }{\fs24\ul Growing Interest in Thalidomide}{\fs24 , GMHC Treatment Issues (visited Jan. 6, 1997) .}}}{ \fs24 A West German company}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 The company, Chemie Grunenthal G.M.B.H., held the original U.S. thalidomide patent, Patent No. 2,830,991. }{\fs24\ul Application of Hartop}{\fs24 , 311 F.2d 249, 265 n.5 (C.C.P.A. 1962) (dissenting opinion).}}}{\fs24 brought it to market, and it was eventually sold by fourteen companies in forty-six countries. Doctors in those countries prescribed it to pregnant women as a relief for morning sickness, not knowing of the drug\rquote s horrible effect on their offspring.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Thalidomide, Scourge of 1950s, May Block AIDS Virus Growth}{\fs24 , Chicago Tribune, Jul. 1, 1993, at 6 [hereinafter }{\fs24\ul Scourge}{\fs24 ], }{\fs24\ul available}{\fs24 }{\fs24\ul in}{\fs24 WL chitrib database.}}}{\fs24 By 1961 or 1962, thalidomide\rquote s teratogenic}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 \'93 Teratogenic\'94 translates roughly as \'93deformative,\'94 or, in the words of a less sensitive era, \'93monster-producing,\'94 S. Rep. No. 1744 (1962), }{\fs24\ul reprinted}{\fs24 }{\fs24\ul in}{\fs24 1962 U.S.C.C.A.N. 2884, }{\fs24\ul available}{ \fs24 }{\fs24\ul in}{\fs24 1962 WL 4821 (views of Senators Estes Kefauver, John A. Carroll, Thomas J. Dodd, Philip A. Hart, and Edward V. Long) [hereinafter Senate Report].}}}{\fs24 effect on gestating children was widely recognized:}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Hartop}{\fs24 , 311 F.2d at 265 n.5 (dissenting opinion) (\'93 It appears to be a matter of general knowledge [in 1962] that thalidomide, although effective as a sedative in human beings, resulted in deformed offspring born to women who had taken it during pregnancy.\'94).}}}{\fs24 mothers taki ng the drug gave birth to children with severe deformities,}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{ \fs24 The vast majority of these children were born in Britain, Germany, and Japan. }{\fs24\ul See}{\fs24 }{\fs24\ul Scourge}{\fs24 , }{\fs24\ul supra}{\fs24 note 4, at 6.}}}{\fs24 including blindness, deafness, missing limbs, and flipper-like appendages.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Thalidomide Victim Learns To Cope With Handicaps}{\fs24 , Chicago Tribune, Aug. 27, 1985, at 10, }{\fs24\ul available}{\fs24 }{\fs24\ul in}{\fs24 WL chitrib database.}}}{\fs24 The exact number of victims is unknown; one newspaper reported the total as 8,000 in 1985,}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Id.}}}{\fs24 12,000 in 1991,}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Firms Seek To Use Banned Thalidomide}{\fs24 , Chicago Tribune, Apr. 11, 1991, at 12 [hereinafter Banned], }{\fs24\ul available}{\fs24 }{\fs24\ul in}{ \fs24 WL chitrib database.}}}{\fs24 and 8,000 again in 1993.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{ \fs24 See }{\fs24\ul Scourge}{\fs24 , }{\fs24\ul supra}{\fs24 note 4, at 6.}}}{\fs24 The exact number is not important, though; the horror and outrage sparked by this disaster is. \par \sect }\sectd \sbknone\linex0\headery1260\footery1260\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 Thalidomide was never approved by the FDA for use in the United States, and therein lies one of the FDA\rquote s greatest success stories. In November of 1960, Dr. Francis Kelsey, the FDA official charged with overseeing thalidomide\rquote s New Drug Application (NDA), was concerned that thalidomide might cause neuropathy, a nerve disease, in some users.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 Senate Report, }{\fs24\ul supra}{\fs24 note 5.}}}{\fs24 She decided that the thalidomide NDA was incomplete and refused to approve it.}{ \cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Id.}}}{\fs24 This kept thalidomide tied up just long enough, since in 1961 the drug\rquote s effect on newborn children became known.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Id.}{\fs24 There is, however, a dispute as to whether Dr. Kelsey suspected thalidomide\rquote s teratogenic effects. }{\fs24\ul See}{\fs24 Steven B. Harris, }{\fs24\ul The Right Lesson To Learn From Thalidomide}{\fs24 (1992) (visited Jan. 6, 1997) .}}}{\fs24 In 1962, President Kennedy presented Dr. Kelsey with a gold medal \emdash the Distinguished Federal Civil Service Award \emdash for her efforts.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs15\fs24\super \chftn }{\fs24 Peter van der Linden, }{\fs24\ul The Medal From The President}{\fs24 (Nov. 11, 199 4) (visited Jan. 7, 1997) (citing The Insight Team, The Sunday Times of London, }{\fs24\ul The Story of Thalidomide}{\fs24 (1979)). Dr. Kelsey still works at the FDA, where she is currently the Director of the Division of Scientific Investigations. }{\fs24\ul Disease Associations: Thalidomide To Be Used For AIDS Related Disorders Treatment}{\fs24 , AIDS Weekly Plus, Nov. 25, 1996 [hereinafter }{\fs24\ul Associations}{\fs24 ], }{\fs24\ul available}{\fs24 }{\fs24\ul in}{\fs24 1996 WL 11522693.}}}{\fs24 \par \sect }\sectd \sbknone\linex0\headery1260\footery1260\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 This resounding success established the FDA \rquote s fundamental orientation on issues involving new drugs: better extremely safe than sorry. Preventing \'93another thalidomide\'94 became the FDA\rquote s number one priority; as the current FDA Commissioner, Dr. David Kessler, put it, \'93 Back in the 1960s and 1970s, post-thalidomide, the agency\rquote s mission was to keep unsafe products off the market.\'94}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul AIDS Activism Improves Medicine}{\fs24 , The Washington Post, Oct. 16, 1992, at 3 [hereinafter }{\fs24\ul Activism}{\fs24 ], }{\fs24\ul available}{ \fs24 }{\fs24\ul in}{\fs24 .}}}{\fs24 Perhaps due to the visibility of inappropriate drug approvals, as opposed to the traditional }{\i\fs24 invisibility}{\fs24 of inappropriate failures to approve new drugs,}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{ \fs24\ul See}{\fs24 Mary J. Ruwart, }{\fs24\ul Death By Regulation}{\fs24 (visited Jan. 7, 1997) (\'93Former FDA Commissioner Alexander Schmidt noted that \lquote ... rarely, if ever, has Congress held a hearing to look into the failure of FDA to approve a new entity; but it has held hundreds of hearings alleging that the FDA has done something wrong by approving a drug....\rquote \'94); }{\fs24\ul see}{\fs24 }{ \fs24\ul also}{\fs24 Harris, }{\fs24\ul supra}{\fs24 note 14 (\'93Even if the local doctor understands the FDA\rquote s role in preventing the patient from being properly treated, \lquote Stenosis of the Government\rquote is not a medical diagnosis, and cannot be written on a death certificate.\'94).}}}{\fs24 some of the \'93protect the public at all costs\'94 attitude has carried though to the present day, with defenders of the status quo \'93constantly\'94 reminding potential reformers of the thalidomide tragedy.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{ \fs24 142 Cong. Rec. S9550-02 (1996) (citing Barbara Mikulski and Nancy Kassebaum, }{\fs24\ul The FDA Can Work Better}{\fs24 , The Washington Post, Jul. 26, 1996 [hereinafter }{\fs24\ul Work Better}{\fs24 ]), }{\fs24\ul available}{\fs24 }{\fs24\ul in}{\fs24 1996 WL 438360.}}}{\fs24 \par Public outrage provided strong support for the FDA\rquote s new approach from the beginning. Books were written on the topic,}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 Linden, }{\fs24\ul supra}{\fs24 note 15.}}}{\fs24 and the word \'93thalidomide\'94 entered our lexicon as a harsh pejorative.}{ \cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 , }{\fs24\ul e.g.}{\fs24 , Tim Richard, }{\fs24\ul Thalidomide Comes To The School House}{\fs24 (visited Jan. 7, 1997) (\'93You would think that our lawmakers would hesitate before exposing students\rquote minds to potential educational thalidomide.\'94).}}}{\fs24 The drug even made a pop culture appearance in Billy Joel\rquote s 1989 hit \'93We Didn\rquote t Start the Fire.\'94}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 Billy Joel, We Didn\rquote t Start The Fire (Columbia 1989) (\'93 [1958:] Lebanon, Charles de Gaulle, California baseball / Starkweather homicide, Children of thalidomide...\'94), }{\fs24\ul available}{\fs24 }{\fs24\ul in}{\fs24 .}}}{\fs24 Recent studies of new uses for thalidomide have suffered accordingly, due largely to \'93disbelief on the part of many people \emdash including physicians \emdash that in light of its catastrophic history, thalidomide would ever be offered t o anyone for any purpose.\'94}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 William Strain, }{ \fs24\ul Thalidomide May Be Useful Against HIV}{\fs24 , AIDS Project (Apr., 1996) (visited Jan. 7, 1997) .}}}{\fs24 \par }\pard \ql \li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 {\fs24 \par }{\b\fs24 Thalidomide And The 1962 Amendments}{\fs24 \par \sect }\sectd \sbknone\linex0\headery1260\footery1260\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 The change in the FDA\rquote s attitude towards new drugs was not the only result of the thalidomide tragedy. Just as the elixir sulfanilamide poisonings of the 1930s prompted Congress to pass the Food, Drug, and Cosmetic Act [hereinafter the Act] in 1938,}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 Food, Drug, and Cosmetic Act, ch. 675, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. \'a7\'a7 301 - 395 (1994)).}}}{\fs24 the horrors of the thalidomide babies pushed Congress to enact the so-called \'93Kefauver Amendments\'94}{ \cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 The 1962 Drug Amendments, 76 Stat. 780 (1962).}}}{\fs24 to the Act in 1962.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul The Evolution of U.S. Drug Law}{\fs24 , FDA (visited Jan. 6, 1997) [hereinafter }{\fs24\ul Evolution}{\fs24 ].}}}{\fs24 \par Senator Kefauver\rquote s motives were noble: he intended the 1962 Amendments to \'93 strengthen and broaden existing laws in the drug field so as to bring about better, safer medicine and to establish a more effective system of enforcement of the drug laws.\'94}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 Senate Report, }{\fs24\ul supra}{\fs24 note 5.}}}{\fs24 His bill was a complex piece of legislation, but its most important provision \emdash the one which would do the most to bring about \'93better, safer medicine\'94 \emdash was section nine, which authorized the FDA to deny an NDA if there was not \'93 substantial evidence\'94 the drug would have its claimed effect.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn } {\fs24 }{\fs24\ul Id.}{\fs24 ; }{\fs24\ul see}{\fs24 }{\fs24\ul also}{\fs24 21 U.S.C. \'a7 505(d) (explaining \'93Grounds for refusing application\'94).}}}{\fs24 The original Food, Drug, and Cosmetic Act had only required that new drugs be safe,}{ \cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 Senate Report, }{\fs24\ul supra}{ \fs24 note 5.}}}{\fs24 but Senator Kefauver argued that \'93the marketing of a safe but ineffective drug may well be positively injurious to the public health\'94 since \'93[w]hen an ineffective drug is prescribed, it is usually in the place of an older but effective drug.\'94}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{ \fs24 Senate Report, }{\fs24\ul supra}{\fs24 note 5.}}}{\fs24 \par \sect }\sectd \sbknone\linex0\headery1260\footery1260\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 As several commentators have noted, there is some irony in the fact that the thalidomide tragedy prompted Congress to require a showing of efficacy and not just safety before FDA could approve a new drug. Thalidomide it self was an effective drug; that is, its tranquilizing qualities were never questioned, and it was even favored over other sedatives since it didn\rquote t produce the usual \'93hangover effects.\'94}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Id.}}}{\fs24 The problem with thalidomide, of course, was it was }{\i\fs24 unsafe}{\fs24 for use by pregnant women, an issue which the original FD&C Act, in theory, adequately addressed.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 Bruce N. Kuhlik, }{\fs24\ul The Origins Of The Generic Drug Scandal And Proposed Amendments To The Food, Drug, and Cosmetic Act}{\fs24 , 45 Food, Drug, and Cosm. L.J. 385, 389 (1990), }{\fs24\ul available}{\fs24 }{\fs24\ul in}{\fs24 WL jlr database.}}}{\fs24 In fact, the introduction of the Kefauver Amendments in Congress predated public knowledge of thalidomide\rquote s dangerousness.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 Harris, }{ \fs24\ul supra}{\fs24 note 14.}}}{\fs24 \par \sect }\sectd \sbknone\linex0\headery1260\footery1260\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 One provision of the 1962 Amendments di d directly address part of the existing law which could have \emdash but turned out not to have \emdash been a problem in the FDA\rquote s consideration of thalidomide. The statute previously dictated that an NDA would automatically be approved in sixty days unless it was specifically disapproved or unless its effective date were postponed up to a maximum of 180 days.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 Senate Report, }{\fs24\ul supra}{\fs24 note 5.}}}{ \fs24 Congress, citing the need \'93to give the physicians of the FDA adequate time to appraise the safety and effectiveness of drugs,\'94}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Id.}}}{\fs24 in section 6 of the bill extended the first deadline to ninety days and abolished the second.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Id.}}}{\fs24 Current law provides that the Secretary of Health and Human Services has 180 days from the filing of an NDA application to approve the application, convince the applicant to voluntarily del ay it, or give the applicant an opportunity for a hearing within the next four months, after which the Secretary\rquote s decision is due within three months.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 21 U.S.C. \'a7 355(c)(1) (1994).}}}{\fs24 In practice, this provision gave the FDA tremendous leverage over drug manufacturers. A company which refused to cooperate and voluntarily delay its NDA might find that NDA denied, perhaps on the grounds that the company developed insufficient information to justify approval, or its other drugs delayed in the approval process. In the drug approval proce ss, time really is money, and a small company whose \'93burn rate\'94 is hovering around one-half million dollars per month cannot afford to make an enemy of its regulator. \par }\pard \ql \li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 {\fs24 \par }{\b\fs24 Dissatisfaction With The FDA: The New Procedures \par \sect }\sectd \sbknone\linex0\headery1260\footery1260\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 Despite the public support behind the 1 962 Amendments, criticism soon began to tear at the edifice of the Food, Drug, and Cosmetic Act. The critics attacked on three fronts. First, as best articulated by Professor Peltzman, the 1962 Amendments resulted in the so-called \'93drug lag.\'94}{ \cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 Peter Barton Hutt and Richard A. Merrill, }{\fs24\ul Food and Drug Law}{\fs24 580-582 (1991) (quoting }{\fs24\ul Hearings Before the Subcomm. on Monopoly of the Senate Small Business Comm.}{\fs24 , 93d Cong., 1}{\fs24\super st}{\fs24 Sess. (1973) (testimony of Sam Peltzman)).}}}{\fs24 Professor Peltzman argued that the Amendments, as of 1973, effectively prevented the development of twenty-five new chemical compounds per year and resulted in a slowing pace of drug development generally.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Id.}}}{\fs24 Unsurprisingly, mandating that the FDA give proposed new drugs another layer of review slowed their approval. Second, the efficacy requirement of Kefauver\rquote s Amendments resulted in increased drug prices. Higher approval hurdles approximately doubled the research and development costs a company could expect to i ncur, and the Amendments acted as a barrier to market entry, weakening competition and allowing prices to rise in the drug industry.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Id.}}}{\fs24 Third, the sick objected that whether or not to use a drug is a personal choice, one that ought not be denied them so lon g as a drug was safe: \'93Each person needs to decide for themselves, in consultation with their physician ... which risks they are willing to take.\'94}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 Ruwart, }{\fs24\ul supra}{\fs24 note 17.}}}{\fs24 \par These criticisms did not fall on a deaf ear at Congress or at the FDA, and new, expedited and expanded proce dures were employed to remedy the perceived problems. The FDA established a formal classification system for NDA and Investigational New Drug, or IND, applications which categorized proposals based primarily on their therapeutic potential.}{ \cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 Dixie Farley, }{\fs24\ul Benefit Vs. Risk: How FDA Approves New Drugs}{\fs24 , FDA (visited Jan. 22, 1997) .}}}{\fs24 The guideline s also took other factors into account, such as whether the proposal concerned an orphan drug (see below).}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Drug Review Priorities}{\fs24 , FDA (visited Jan. 22, 1997) .}}}{\fs24 Then, in 1987, the FDA established a new category, Type AA, for potential AIDS therapies; type AA drugs receive the FDA\rquote s highest priority in the drug review process.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Expanded Access And Expedited Approval Of New Therapies Related To HIV/AIDS}{\fs24 , FDA (visited Jan. 6, 1997) [hereinafter }{\fs24\ul HIV/AIDS}{\fs24 ].}}}{\fs24 \par In 1983, Congress passed the Orphan Drug Act}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 Orphan Drug Act, 96 Stat. 2049 (1983).}}}{\fs24 to provide incentives for manufacturers to develop orphans - drugs for treating rare diseases.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 See }{\fs24\ul Evolution}{\fs24 , }{\fs24\ul supra}{\fs24 note 25.}}}{\fs24 The law permits manufacturers advantageous tax deductions and exclusive marketing rights for new orphan drugs.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Id.}}}{\fs24 \par \sect }\sectd \sbknone\linex0\headery1260\footery1260\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 The FDA has also set up programs under its \'93compassionate use\'94 framework to allow access to unapproved drugs on a case-by-case basis for patients whose serious illnesses have not responded to other therapies.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 Ken Flieger, }{\fs24\ul FDA Finds New Ways To Speed Treatments To Patients}{\fs24 , FDA (1995) (visite d Jan. 22, 1997) ; John S. James, }{\fs24\ul Thalidomide For Wasting Syndrome: Progress Toward Compromise}{\fs24 , AIDS Treatment News (Nov. 3, 1995) (visited Jan. 7, 1997) .}}}{\fs24 The FDA will invoke the primary compassionate use mechanism, the Treatment IND, if the requested drug is reasonably safe, if there are adequate protections of the patient such as informed consent, and if the doctor administering the drug keeps records as to its effect on the pat ient.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Hearings Before the Senate Comm. on Labor and Human Resources}{\fs24 , 104th Cong., 2d Sess. (Jul. 30, 1996) (testimony of Jerold Mande) [hereinafter Mande].}}}{\fs24 The FDA significantly expanded and revised the Treatment IND program in 1987.}{ \cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 Flieger, }{\fs24\ul supra}{\fs24 note 47.}}}{\fs24 A related mechanism, the \'93parallel track\'94 policy, gives patients who are unable to participate in clinical studies access to untested drugs.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Id.}}}{\fs24 \par The FDA has also instituted expedited review and accelerated approval for new drugs. Expedited review, begun in 1988, allows the FDA to assist manufacturers in setting up trials and to waive the phase III study.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 Mande, }{\fs24\ul supra}{\fs24 note 48.}}}{\fs24 Under accelerated approval, begun in 1992, the FDA may allow promising drugs to reach the market before their complete effectiveness is demonstrated.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Id.}{\fs24 ; }{\fs24\ul see}{\fs24 }{\fs24\ul also}{\fs24 Flieger, }{\fs24\ul supra}{\fs24 note 47.}}}{\fs24 \par }\pard \ql \li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 {\fs24 \par }{\b\fs24 The New Uses Of Thalidomide Under Expanded And Accelerated FDA Procedures}{\fs24 \par \sect }\sectd \sbknone\linex0\headery1260\footery1260\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 After thalidomide\rquote s fall from grace, few people imagined that it would ever be prescribed again. The surprising truth, however, is that thalidomide has been in nearly constant use since scientists discovered its teratogenic effects over thirty years ago.}{ \cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 Denny Smith, }{\fs24\ul Thalidomide And HIV: Several Possible Uses}{\fs24 (Apr. 21, 1995) (visited Jan. 6, 1997) .}}}{\fs24 This began after an Israeli doctor, treating a patient with Hansen\rquote s disease, or leprosy, administered thalidomide in an attempt to sedate his patient.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs15\fs24\super \chftn }{\fs24 Wendy Maritz, }{\fs24\ul Thalidomide - Hope For HIV And TB Sufferers}{\fs24 , Strategic Health Review (Nov. 28, 1996) (visited Jan. 6, 1997) .}}}{\fs24 The doctor found that not only did the medication calm the patient, it also helped to fight the disease.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Id.}}}{\fs24 Leprosy patients are the primary consumers of thalidomide today,}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 Carol Blaney, }{\fs24\ul Second Thoughts About Thalidomide}{\fs24 , Medical Sciences Bulletin (visited Jan. 6, 1997) .}}}{\fs24 and the drug is available through the U.S. Public Health Service as part of a compassionate use protocol.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 }{\fs24\ul Banned}{\fs24 , }{\fs24\ul supra}{\fs24 note 10.}}}{\fs24 Celgene, one of the corporations investigating new uses for thalidomide, received Orphan Drug status for its use of thalidomide as a leprosy treatment in 1993}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Thalidomide Now Approved By FDA For A Fourth Application}{\fs24 , Doctor\rquote s Guide (Mar. 20, 1996) (visited Jan. 12, 1997) [hereinafter }{\fs24\ul Fourth}{\fs24 ].}}}{\fs24 and is expected to submit an NDA for that indication in early 1997.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul FDA Application: Celgene Seeks O.K. To Use Thalidomide In Leprosy Cases}{\fs24 , Chicago Tribune, Dec. 26, 1996, at 7 [hereinafter }{\fs24\ul Application}{\fs24 ], }{\fs24\ul available}{\fs24 }{\fs24\ul in}{\fs24 WL chitrib database.}}}{\fs24 \par \sect }\sectd \sbknone\linex0\headery1260\footery1260\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 Researchers, interested in thalidomide \rquote s unexplained success against leprosy, began to investigate the drug.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 Blaney, }{\fs24\ul supra}{\fs24 note 56.}}}{\fs24 They knew that leprosy is the result of a bacterial infection and that some leprosy pat ients suffer from a skin condition known as erythema nodosum leprosum, or ENL, if the disease interferes with their immune system.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 Lowell, }{\fs24\ul supra}{\fs24 note 2.}}}{\fs24 Studies indicated that thalidomide, a drug with no antimicrobial effects (i.e. thalidomide couldn\rquote t fight the leprosy bacte ria itself) was very effective in treating ENL, so scientists reasoned that thalidomide acted directly on the immune system.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Id.}}}{\fs24 Further experiments showed that thalidomide reduced the immune system\rquote s production and release of a certain hormone-like protein \emdash tumor necrosis factor, or TNF \emdash which acts as an intercellular messenger.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Id.}}}{\fs24 In normal concentrations TNF helps the body fight pathogens, but certain chronic conditions cause the body to overproduce it, leading to a number of unpleasant effects.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 Mark Bower, }{\fs24\ul Thalidomide}{\fs24 , Project Inform (last modified Jan. 20, 1996) .}}}{\fs24 This was confirmed by one AIDS study in which researchers administered TNF itself to patients and found it significantly aggravated their symptoms.}{ \cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 Lowell, }{\fs24\ul supra}{\fs24 note 2.}}}{\fs24 Thalidomide\rquote s ability to inhibit the body\rquote s use of TNF, like other TNF inhibitors, thus generally doesn\rquote t attack the disease directly; instead it \'93 attack[s] an underlying immune abnormality that occurs because of the disease ... mak[ing] the disease easier to deal with in a more direct fashion.\'94}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 Blaney, }{\fs24\ul supra}{\fs24 note 56.}}}{\fs24 In short, thalidomide prevents the immune system of a person suffering from a chronic illness like leprosy from actually harming the person. \par \sect }\sectd \sbknone\linex0\headery1260\footery1260\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 \sect }\sectd \sbknone\linex0\headery1260\footery1260\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 Understanding the role of TNF in leprosy was not the most significant finding of the researchers whose work is described above. Leprosy is, after all, a rare,}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 Slightly over 2,000 new leprosy cases were reported in the United States between 1984 and 1993. }{ \fs24\ul See}{\fs24 }{\fs24\ul Application}{\fs24 , }{\fs24\ul supra}{\fs24 note 59.}}}{\fs24 though terrible, disease. Instead, the real insight was the role thalidomide might play against other chronic diseases in which the body\rquote s TNF overproduction causes serious and long-term harm: \'93Once the mechanism [of action] in leprosy was established, we looked at other diseases associated with high levels of TNF.\'94}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 Katie Rodgers, }{\fs24\ul Thalidomide\rquote s Effect On AIDS And TB Under Scrutiny}{\fs24 , Drug Topics, Mar. 7, 1994, at 24, }{\fs24\ul available}{\fs24 }{\fs24\ul in}{\fs24 1994 WL 2885995.}}}{\fs24 This second-stage research has involved a large number of afflictions. Diabetes research indicates that TNF may have an impact on a diabetic\rquote s insulin absorption and use, as well as on glucose uptake, and researchers at Andrulis,}{ \cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 Andrulis\rquote web site is located at .}}}{\fs24 another company researching new uses for thalidomide, have conducted a phase II trial of the drug.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 Katie Rodgers, }{\fs24\ul Diabetes Care: New Research, New Hope}{\fs24 , Drug Topics, Jun. 12, 1995, at 62, }{\fs24\ul available}{\fs24 }{\fs24\ul in}{\fs24 1995 WL 8066442.}}}{\fs24 Andrulis researchers are further investigating whether the devastating neurological damage associated with Alzheimer\rquote s disease can be mitigated by thalidomide.}{ \cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Thalidomide Studied For Multiple Sclerosis}{ \fs24 , Drug News & Perspectives, Nov. 28, 1995 [hereinafter }{\fs24\ul MS}{\fs24 ], }{\fs24\ul available}{\fs24 }{\fs24\ul in}{\fs24 WL drugnews database.}}}{\fs24 The company holds a patent for the use of thalidomide in the treatment of Alzheimers and other neurological disorders.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Andrulis Announces Collaboration, Patent Using Thalidomide For Alzheimer\rquote s}{\fs24 , Drug News & Perspectives, Sep. 5, 1995, }{\fs24\ul available} {\fs24 }{\fs24\ul in}{\fs24 WL drugnews database.}}}{\fs24 Celgene}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 Celgene\rquote s web site is located at .}}}{\fs24 is also investigating thalidomide\rquote s potential as a brain cancer therapy.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Thalidomide, EntreMed Clinical Data}{\fs24 , R&D Focus Drug News, Dec. 9, 1996, }{\fs24\ul available}{\fs24 }{\fs24\ul in}{\fs24 1996 WL 13640914.}}}{\fs24 Still other researchers a re looking at uses for thalidomide in the treatment of bacterial meningitis, rheumatoid arthritis, multiple sclerosis, tuberculosis, and a variety of other diseases.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 , }{\fs24\ul e.g.}{\fs24 , Rodgers, }{\fs24\ul supra}{\fs24 note 68; }{\fs24\ul MS}{\fs24 , }{\fs24\ul supra}{\fs24 note 71.}}}{\fs24 \par At least judging by the amount of attention it has garnered, however, the most exciting area of thalidomide research involves HIV and AIDS. While ordinarily characterized as an \'93immune deficiency,\'94 a term which seems to indicate that the body \rquote s immune system is incapable of reacting to disease, HIV also causes an \'93autoaggressive\'94 reaction, leading to the overproduction of TNF.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 Smith, }{\fs24\ul supra}{\fs24 note 53.}}}{\fs24 As with other diseases, too much TNF aggravates the symptoms of AIDS, which include: prurigo nodularis, itchy bumps on the skin;}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Prurigo Nodularis: Thalidomide}{\fs24 (last modified Jan. 26, 1996) .}}}{\fs24 diarrhea;}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 Edward King, }{\fs24\ul Thalidomide And AIDS} {\fs24 (visited Jan. 6, 1997) ; }{\fs24\ul Thalidomide Now Available To Treat AIDS Weight Loss}{\fs24 , Medical Tribune (Jun. 6, 1996) (visited Jan. 6, 1997) .}}}{\fs24 ulcers;}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 King, }{\fs24\ul supra}{\fs24 note 78; Lowell, }{\fs24\ul supra}{\fs24 note 2. Andrulis plans to file an NDA for this indication in early 1997. }{\fs24\ul See}{\fs24 }{\fs24\ul Associations}{\fs24 , }{\fs24\ul supra}{\fs24 note 15.}}}{\fs24 and cachexia, a severe weight loss condition also known as \'93wasting.\'94}{ \cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 Lowell, }{\fs24\ul supra}{\fs24 note 2; }{\fs24\ul Thalidomide Submitted for NDAs For Use In Leprosy And AIDS Cachexia}{\fs24 , Doctor\rquote s Guide (Nov. 11, 1996) (visited Jan. 12, 1997) .}}}{\fs24 Thalidomide currently is being tested as a therapy to all of those symptoms. \par \sect }\sectd \sbknone\linex0\headery1260\footery1260\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 Most importantly, unlike thalidomide research for other diseases, AIDS-related research has also uncovered evidence that thalidomide may actually help retard the development of the disease itself. Experiments have shown that TNF can both activate latent HIV viruses}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 Lowell, }{\fs24\ul supra}{\fs24 note 2.}}}{\fs24 and enhance HIV replication.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 Smith, }{\fs24\ul supra}{\fs24 note 53.}}}{\fs24 It is thus possible that a TNF inhibitor such as thalidomide may actually reduce a patient\rquote s \'93viral burden.\'94}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 Lowell, }{\fs24\ul supra}{\fs24 note 2.}}}{\fs24 \par \sect }\sectd \sbknone\linex0\headery1260\footery1260\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 Perhaps unsurprisi ngly, given the constant pressure applied by AIDS activists to the FDA,}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 }{\fs24\ul Activism}{\fs24 , }{\fs24\ul supra}{\fs24 note 16.}}}{\fs24 AIDS-related indications of thalidomide have been the beneficiary of the full range of expedited and expanded FDA procedures. Celgene has received Orphan Drug status for thalidomide\rquote s use against both cachexia and mouth ulcers,}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 }{\fs24\ul Fourth}{\fs24 , }{\fs24\ul supra}{\fs24 note 58.}}}{\fs24 and Andrulis won an Orphan Drug designation for thalidomide\rquote s use against a different type of mouth sore.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Treatment: Thalidomide Approved As Treatment For AIDS-Associated Ulcers}{\fs24 , AIDS Weekly, Jun. 12, 1995 [hereinafter }{\fs24\ul Ulcers}{\fs24 ], }{ \fs24\ul available}{\fs24 }{\fs24\ul in}{\fs24 1995 WL 2242284.}}}{\fs24 Treatment INDs and parallel tracking are available to sufferers of both ulcers and cachexia.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 Ivy Fleischer Kupec, }{\fs24\ul Thalidomide Update}{\fs24 , FDA (Feb. 26, 1996) (visited Jan. 6, 1997) .}}}{\fs24 The FDA also has invoked its expedited review by assisting the corporations in designing and implementing clinical trials,}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Id.}}}{\fs24 and by allowing phases II and III of the required studies to be combined.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 }{\fs24\ul Ulcers}{\fs24 , }{\fs24\ul supra}{\fs24 note 86; }{\fs24\ul Cachexia (Treatment): Pivotal Trial Completed For Thalidomide In AIDS Patients}{\fs24 , AIDS Weekly Plus, Oct. 21, 1996, }{ \fs24\ul available}{\fs24 }{\fs24\ul in}{\fs24 1996 WL 11522467; Rodgers, }{\fs24\ul supra}{\fs24 note 68.}}}{\fs24 The devotion of the FDA\rquote s time and resources seems to have paid off: Celgene plans to apply for an NDA for thalidomide\rquote s use against cachexia early this year.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Celgene To Ask FDA Approval For Thalidomide In AIDS Use}{\fs24 , Nando (Jul. 9, 1996) (visited Jan. 7, 1997) .}}}{\fs24 \par In the rush to test thalidomide as a treatment for all of those diseases and symptoms, the drug\rquote s most obvious lesson \emdash the potential for devastating birth defects \emdash has not been forgotten.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 At least not in this country; Brazil, however, already has another thalidomide generation. }{\fs24\ul See}{\fs24 }{\fs24\ul Associations}{\fs24 , }{\fs24\ul supra}{\fs24 note 15.}}}{\fs24 An FDA advisory committee held two days of hearings on this subject in November, 1996,}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Thalidomide Hearings}{\fs24 , Drug Topics, Oct. 21, 1996, at 22, }{\fs24\ul available}{ \fs24 }{\fs24\ul in}{\fs24 1996 WL 11132593.}}}{\fs24 where experts advised that the FDA consider mandating two forms of birth controls for every pre-menopausal non-sterile woman involved in any thalidomide study.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 }{\fs24\ul Associations}{\fs24 , }{\fs24\ul supra}{\fs24 note 15.}}} {\fs24 Some researchers, taking no chances, have completely barred pregnant or nursing women from participating in their studies.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 }{\fs24\ul Prurigo Nodularis: Thalidomide}{\fs24 , }{\fs24\ul supra}{\fs24 note 77.}}}{\fs24 This has not set well with some AIDS interest groups, who argue that \'93[p]eople facing serious health concerns deserve to make their own informed treatment decisions.\'94}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 Smith, }{\fs24\ul supra}{\fs24 note 53.}}}{\fs24 Given the horror of the previous generation of thalidomide babies, however, they are unlikely to prevail. \par }\pard \ql \li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 {\fs24 \par }{\b\fs24 Current Events}{\fs24 \par \sect }\sectd \sbknone\linex0\headery1260\footery1260\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 The interrelationship between thalidomide and the evolution of the FDA did not stop at the FDA\rquote s recent procedural innovations. Arguments still swirl around the controversial drug and the FDA\rquote s handling of it and similar drugs. But the attacks of the FDA\rquote s critics are not new; in fact, they are the same criticisms which led the FDA to implement its new procedures only a few years ago. \par The alleged \'93drug lag\'94 is again at the heart of the debate. Citing the now-familiar proposition that \'93[p]atients can be harmed by delay in approving safe and effective new medicines just as they can by the approval of unsafe new medicines,\'94}{ \cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 }{\fs24\ul Work Better}{\fs24 , }{ \fs24\ul supra}{\fs24 note 18.}}}{\fs24 reformers have accused the FDA of adhering to its thalidomide-centered approach to drug approval.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 141 Cong. Rec. E1273-02 (1996) (quoting James P. Driscoll, }{\fs24\ul The FDA Can Work Better}{\fs24 , The Los Angeles Times, Jun. 15, 1996), }{\fs24\ul available}{\fs24 }{\fs24\ul in}{\fs24 1996 WL 438360.}}}{\fs24 One particularly harsh critic even maintains that the FDA\rquote s glacial review of beta-blockers resulted in the death of hundreds of thousands by cardiac arrhythmia.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 Harris, }{\fs24\ul supra}{\fs24 note 14.}}}{\fs24 Critics also attack the drug review process as being too costly, averaging nearly $350M per drug.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul The Access to Medical Treatment Act: Hearings on S. 1035 Before the Senate Comm. on Labor and Human Resources}{\fs24 , 104}{\fs24\super th}{\fs24 Cong. (1996) (opening statement of Senator Kassebaum, Committee Chair) [hereinafter Kassebaum], }{\fs24\ul available}{\fs24 }{\fs24\ul in}{\fs24 1996 WL 10830240.}}}{\fs24 Finally, critics argue that a chronically and terminally ill person\rquote s decision to take a drug should rest between that person and their doctor alone.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 { \cs15\fs24\super \chftn }{\fs24 141 Cong. Rec. E1424-01 (1995) (statement of Rep. Peter A. Defazio), }{\fs24\ul available}{\fs24 }{\fs24\ul in}{\fs24 1996 WL 411624. This sentiment also underlies the dispute in }{\fs24\ul Quill v. Vacco}{\fs24 , one of the most important cases heard by the Supreme Court in 1997. }{\fs24\ul See}{\fs24 }{\fs24\ul Interview: Dr. Timothy Quill Discusses Doctor-Assisted Suicide}{\fs24 , CBS This Morning, Jan. 8, 1997, }{\fs24\ul available}{\fs24 }{\fs24\ul in}{ \fs24 1997 WL 5621064.}}}{\fs24 They reason that efficacy is irrelevant for a new drug with the potential of treating patients with diseases like AIDS, since with the drug sufferers might get better, but without the drug they wil l surely die; so why not let them make their own treatment decisions? \par \sect }\sectd \sbknone\linex0\headery1260\footery1260\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 \sect }\sectd \sbknone\linex0\headery1260\footery1260\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 The FDA takes strong issue with these accusations. Dr. Kessler put it bluntly: \'93The FDA is a world-wide leader when it comes to reviewing and approving new drugs rapidly and efficiently,\'94 so \'93 [i]t is time to put to rest the incorrect perception that American patients generally suffer from a so-called drug lag.\'94}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Kessler Denies FDA\rquote s Time Lag In Reviewing And Approving New Drugs}{\fs24 , Pharmaceutical Business News, Dec. 20, 1995, }{\fs24\ul available}{ \fs24 }{\fs24\ul in}{\fs24 1995 WL 9599578.}}}{\fs24 The FDA published a report in 1995, entitled \'93Timely Access to New Drugs in the 1990s: An International Comparison,\'94 which d emonstrates that, on average, the FDA approves drugs at least as fast as, if not faster than, its counterparts in other countries.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 }{\fs24\ul HIV/AIDS}{\fs24 , }{\fs24\ul supra}{\fs24 note 43.}}}{\fs24 The FDA also points out that AIDS-related pharmaceuticals are approved particularly quickly: of the eight antiretrovirals approved as of June 1996, the longest took six months.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Id.}}}{\fs24 Finally, the FDA notes that 1996 was its best year on record for drug approvals, as one hundred and thirty-one new drugs were approved, a sixty percent increase over 1995.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 Donald C. McLearn, }{\fs24\ul FDA Approvals In 1996 Set New Records}{\fs24 , FDA (Jan. 14, 1997) (visited Jan. 22, 1997) .}}}{\fs24 Dr. Kessler, speaking to the Food and Drug Law Institute, noted that the FDA approved forty-six New Molecular Entities (NMEs}{ \cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 NMEs are \'93 products containing an active substance that had never before been approved for marketing in any form in the United States.\'94 }{\fs24\ul Id.}{\fs24 FDA considers them a particularly good symbol of its efficiency in getting new drugs to patients. David Kessler, Remarks to the Food and Drug Law Institute (1996), }{\fs24\ul available}{\fs24 }{\fs24\ul in}{\fs24 .}}}{\fs24 These groups, who feel it is \'93patronizing\'94 for the FDA to tell AIDS-sufferers that they \'93can\rquote t take control of their own therapy,\'94}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 }{\fs24\ul Illicit Clubs}{\fs24 , }{\fs24\ul supra}{\fs24 note 108.}}}{\fs24 have set up their own compassionate use programs, participation in which generally requires a doctor\rquote s prescription and a patient\rquote s informed consent.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul FDA And Underground Thalidomide}{\fs24 , GMHC Treatment Issues (visited Jan. 6, 1997) .}}}{\fs24 The FDA repeatedly warned the clubs to stop supplying thalidomide,}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 Lowell, }{\fs24\ul supra}{\fs24 note 2.}}}{\fs24 but the clubs refused until a meeting between them, the FDA, and Celgene, in which they agreed to stop supplying the drug when the FDA made it widely available.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 James, }{\fs24\ul supra}{\fs24 note 47.}}}{\fs24 \par \sect }\sectd \sbknone\linex0\headery1260\footery1260\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 Whatever advances the FDA\rquote s expedited and expanded procedures represent, AIDS patients have continued to demand access to thalidomide.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 }{\fs24\ul Associations}{\fs24 , }{\fs24\ul supra}{\fs24 note 15.}}}{\fs24 Responding to such pressure, Congress has jumped into the fray with two pieces of proposed legislation: The Access to Medical Treatment Act [hereinafter the Access Act] and the Food and Drug Ad ministration Performance and Accountability Act of 1995 [hereinafter the Performance Act]. \par \sect }\sectd \sbknone\linex0\headery1260\footery1260\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 The Access Act,}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 S. 1035, 104}{\fs24\super th}{\fs24 Cong. (1995), }{\fs24\ul available}{\fs24 }{\fs24\ul in}{\fs24 WL cong-billtxt database; H.R. 2019, 104}{\fs24\super th}{\fs24 Cong. (1995), }{\fs24\ul available}{\fs24 }{\fs24\ul in}{\fs24 WL cong-billtxt database.}}}{\fs24 sponsored by Senate Minority Leader Tom Daschle and cosponsored by at least sixteen other senators,}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Access to Medical Treatment Act}{\fs24 , Natural Health Village (visited Jan. 12, 1997) .}}}{ \fs24 would allow patients access to an unapproved drug if there is no evidence that it is unsafe, if the manufacturer is licensed, and if informed consent is obtained.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Bill to Increase Alternative Medicine Access Has Many Supporters and Many in Doubt}{\fs24 , Health Legislation & Regulation, Jul. 31, 1996, }{\fs24\ul available}{\fs24 }{\fs24\ul in}{\fs24 1996 WL 11279285.}}}{\fs24 Essentially, the Access Act amounts to a repeal of the efficacy provisions of the 1962 Amendments, at least so far as certain drugs and patients are concerned. Senator Daschle, testifying before the Senate Labor & Human Resources Committee, said that \'93People should have the right to choose from among a full range of medical treatment options \emdash particularly people who suffer from chronic and potentially fatal conditions that do not respond to conventional treatments.\'94}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Medical Treatment: He arings on S. 1035 Before the Senate Comm. on Labor and Human Resources}{\fs24 , 104}{\fs24\super th}{\fs24 Cong. (1996) (statement of Senator Daschle), }{\fs24\ul available}{\fs24 }{\fs24\ul in}{\fs24 1996 WL 10830241.}}}{\fs24 Jerold Mande, Commissioner Kessler\rquote s Executive Assistant, delivered the FDA\rquote s response to the Committee.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 Mande, }{\fs24\ul supra}{\fs24 note 48.}}}{\fs24 Mande pointed to the FDA\rquote s recent treatment of thalidomide as evidence of the FDA \rquote s \'93flexibility and open mindedness\'94 and explained the various ways in which the FDA is able to speed approval and access to promising new drugs.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Id.}}}{\fs24 Mande also repeated the FDA\rquote s position on unapproved alternative therapies: allowing access to unapproved drugs exposes vulnerable patients to unscrupulous snake-oil salesmen and may encourage such patients to substitute ineffective therapies for efficacious ones.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Id.}}}{\fs24 Senator Kassebaum, the Committee Chair, stated the dilemma succinctly: \'93The fundame ntal question before us today is how to achieve [the] balance between freedom of choice, on the one hand, and a reasonable assurance of safety and effectiveness, on the other.\'94}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul See}{\fs24 Kassebaum, }{\fs24\ul supra}{\fs24 note 99.}}}{\fs24 \par \sect }\sectd \sbknone\linex0\headery1260\footery1260\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 The Performance Act, sponsored by Senator Kassebaum, is an attempt to answer that question. Her bill would \'93substantially shorten and make more efficient new product development and FDA review times without compromising either safety or effectiveness. \'94}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Id.}}}{\fs24 The Performance Act would establish agency performance standards, shorten new drug approval timetables, and require the FDA to assist companies by helping to design test trials and by telling them what standards will be used to evaluate new drugs.}{ \cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 Liz Skinner, }{\fs24\ul The FDA: It\rquote s Broke}{ \fs24 , Warfield\rquote s Business Record, Apr. 29, 1996, }{\fs24\ul available}{\fs24 }{\fs24\ul in}{\fs24 1996 WL 8797809.}}}{\fs24 In short, Senator Kassebaum wants the best of both words: fast and efficient yet fu ll and complete drug review. Dr. Kessler, testifying on the bill, said that while he shared her goals, he did not believe that the FDA could meet the bill\rquote s requirements without additional resources.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 }{\fs24\ul Labor Changes In FDA: Hearings on S. 1477 Before the Senate Comm. on Labor and Human Resources}{\fs24 , 104}{\fs24\super th}{\fs24 Cong. (1996) (statement of FDA Commissioner Kessler), }{\fs24\ul available}{\fs24 }{\fs24\ul in}{\fs24 1996 WL 7135603.} }}{\fs24 Senator Kennedy, speaking on the floor of the Senate, predicted that the Performance Act would place the FDA in the grips of industry, leading to crises similar to Britain\rquote s mad-cow disease disaster.}{\cs15\fs24\super \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs15\fs24\super \chftn }{\fs24 142 Cong. Rec. S3203-01 (1996) (statement of Senator Kennedy).}}}{\fs24 \par }\pard \ql \li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 {\fs24 \par }{\b\fs24 Conclusion}{\fs24 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 {\fs24 The exact resolution of the debate between FDA review and patient autonomy is, at this stage, unclear. Regardless, it appears certain that thalidomide\rquote s unique status \emdash first as the impetus for the empowering of the FDA in 1962, now as a major factor pushing for a stripping away much of that power \emdash will continue for the foreseeable future. \par }}