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\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 \snext0 Normal;}{\*\cs10 \additive Default Paragraph Font;}{\*\cs15 \additive footnote reference;}{\*\cs16 \additive \b\ul\cf11 Hypertext;}}{\info{\title Political Science and the FDA}
{\author Beth Ann Vida}{\operator Chad and Sarah Ludington}{\creatim\yr2002\mo7\dy8\hr12\min49}{\revtim\yr2002\mo7\dy8\hr12\min49}{\version2}{\edmins0}{\nofpages42}{\nofwords6122}{\nofchars34898}{\*\company Covington & Burling}{\nofcharsws42857}
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{\pntxtb (}{\pntxta )}}\pard\plain \qc \li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 Political Science and the FDA}{\fs24 
\par Clinton Hermes}{\fs24 
\par }\pard \qc \li0\ri0\nowidctlpar\faauto\rin0\lin0\itap0 {\fs24 Food and Drug Law
\par Professor Peter Barton Hutt
\par Winter 2001
\par \sect }\sectd \pgnrestart\linex0\headery1440\footery1440\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 {\field{\*\fldinst {\fs24 PAGE }}{\fldrslt {\fs24\lang1024\langfe1024\noproof 1}}}{\fs24 
\par }\pard \ql \li0\ri0\nowidctlpar\faauto\rin0\lin0\itap0 {\fs24 
\par }}\pard\plain \ql \fi-720\li720\ri0\sl480\slmult1\nowidctlpar\tx-1440\faauto\rin0\lin720\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\b\fs24 I.\tab Introduction}{\fs24 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 {\fs24 Politics has been characterized as the struggle for \'93who gets what, when, and how,\'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 }{\i\fs24 See, e.g.}{\fs24 , }{\scaps\fs24 Harold D. Lasswell, Politics \endash  Who Gets What, When, How}{\fs24 
 (1958).}}}{\fs24  and political science is the study of how that struggle is conducted and resolved.  Since there is so much to \'93get\'94 when it comes to the industries regulated by the Food and Drug Administration (\'93FDA\'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 
FDA-regulated products account for twenty-five cents of ever consumer dollar spent in the United States.  }{\i\fs24 See}{\fs24  Food and Drug Administration, }{\i\fs24 About the U.S. Food and Drug Administration}{\fs24  (visited January 13, 2001) <}{
\cs16\fs24\cf1 http://www.fda.gov/opacom/hpview.html}{\cs16\b\fs24\cf1 >}{\cs16\fs24\cf1 .}}}{\fs24  it is somewhat surprising that relatively little study of FDA has been undertaken by political scientis
ts.  In describing what political scientists can add to the study of regulatory policy apart from the contributions of economists, lawyers, sociologists, and journalists, renowned political scientist Morris Fiorina noted that while these other professiona
l
s typically study behavior undertaken within the constraints imposed by government officials, political scientists ask why the constraints are imposed in the first place and consider externally-imposed constraints as only one factor in determining why a g
overnment or a governmental unit behaves the way it does.}{\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 }{
\i\fs24 See }{\fs24 Morris P. Fiorina, }{\i\fs24 Group Concentration and the Delegation of Legislative Authority}{\fs24 , }{\i\fs24 in}{\fs24  }{\scaps\fs24 Regulatory Policy and the Social Sciences}{\fs24  173, 173-74 (Roger G. Noll ed., 1985).}}}{\fs24 
  This essay collects and analyzes the important political science works on FDA, with an eye both to serving as a springboard for future research on FDA decision-making and to drawing conclusions from extant research.
\par \sect }\sectd \sbknone\linex0\headery1440\footery1440\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 
Both of these goals require a brief discussion of \'93explanatory frameworks;\'94 the future researcher will appreciate a conceptual categorization of the political science literature, and any analysis of existing studies should at least make
 explicit which framework those studies implicitly adopt.  Social scientists have devised many sets of explanatory frameworks for analyzing government decision-making, and a good beginning reference point is Theodore R. Marmor\rquote s }{\i\fs24 
Commentary, or the Notes and Asides of an FDA Amateur and Professional Political Scientist Specializing in Battles over the Modern Welfare State}{\fs24 .}{\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 82 }{\scaps\fs24 Va. L. Rev. }{\fs24 1867 (1996).}}}{\fs24   Marmor defines explanatory frameworks (or 
\'93conceptual models\'94) as the \'93intellectual orientation and conceptual categories the analyst b
rings to complex political and organizational phenomena:  how problems are framed, what unit of analysis is presumed, what focal notions, and what patterns of inference,\'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 }{\i\fs24 Id. }{\fs24 at 1870.}}}{\fs24 
 and he rightly criticizes other writers on FDA for failing to be precise about their own explanatory frameworks.
\par \sect }\sectd \sbknone\linex0\headery1440\footery1440\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 
Basing his discussion on a well-known work by Graham Allison,}{\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 }{
\scaps\fs24 Graham T. Allison, Essence of Decision:  Explaining the Cuban Missile Crisis}{\fs24  (1971).}{ }}}{\fs24  Marmor describes three such frameworks:  the \'93rational (or unitary) actor model,\'94 the \'93organizational process model,\'94
 and the \'93bureaucratic politics model.\'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 Marmor, }{
\i\fs24 supra}{\fs24  note 4, at 1870-71.  It should be emphasized that this set of explanatory frameworks is not the only set that has been formulated, but it is one of the best known.}}}{\fs24   The }{\i\fs24 rational actor model}{\fs24 
, as its name might imply, views FDA as merely a representative of the government.}{\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 This idea has also been expressed by the \'93principle-agent model\'94 of bureaucratic functioning.  For a survey of the literature adopting this view, see }{\scaps\fs24 
B. Dan Wood & Richard W. Waterman, Bureaucratic Dynamics}{\fs24  22-26 (1994).}}}{\fs24   Under this model, when FDA takes some action or stance, it does so because the government as a whole has made a strategic choice that this action or st
ance was the best under the circumstances.  Particularly relevant to this sort of analysis are the policy reasons behind certain regulations, enforcement mechanisms, and approval patterns.  The }{\i\fs24 organizational process model}{\fs24 
 directs its attention to the laws
 and habits that form the processes a unit or sub-unit of government (here, FDA) follows.  While the rational actor model might explain an FDA regulation by focusing on the reasons why such a regulation might objectively be a good idea, the organizational
 process model pays more attention to \'93what reasons made sense to a particular organization with its distinctive habits, routine channels of information, and crucial internal history.\'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 }{\i\fs24 Id.}{\fs24  at 1871.}}}{\fs24   Finally, the }{\i\fs24 bureaucratic politics model}{\fs24 
 emphasizes the interaction of individual actors in \'93bargaining games.\'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 }{\i\fs24 Id.}}}{\fs24   This model explains a given FDA action \'93as the momentary resultant (or vector) of individuals, interests, and interactions.\'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 }{\i\fs24 Id.}{\fs24  at 1872.}}}{\fs24 
\par \sect }\sectd \sbknone\linex0\headery1440\footery1440\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 
Before the political science literature is discussed using these explanatory framewor
ks, a few cautionary notes are warranted.  First, the frameworks are not mutually exclusive.  A scholar can analyze FDA decision-making using more than one.  This is because the frameworks are not competing explanations of how FDA works; rather, they are 
simply different ways of sifting through a nearly infinite pool of data to determine what is important.  Therefore, this essay can at most suggest which framework is the most useful vis-\'e0-vis FDA; it cannot say which is \'93right.\'94
  Second, all conceptual mode
ls blur at the edges.  Political scientists are sometimes not explicit about what they believe is important in the picture they present, and they include different sorts of facts that are primary for different frameworks.  Moreover, even if they attempted
 
to confine their descriptions to a single model, the models themselves would often not oblige.  For example, historical information, depending on its presentation, can suggest either a unitary government view (as it has been categorized here) or an organi
zational habits and routines view; likewise, information about FDA\rquote 
s incentives can be relevant both to the latter view and to the bureaucratic politics model.  Finally, a few works fit so awkwardly into any one of these models that they are categorized separately below.
\par }\pard \ql \li0\ri0\nowidctlpar\faauto\rin0\lin0\itap0 {\fs24 
\par }\pard \ql \fi-720\li720\ri0\nowidctlpar\tx-1440\faauto\rin0\lin720\itap0 {\b\fs24 II.\tab The Rational Actor Model
\par }\pard \ql \li0\ri0\nowidctlpar\faauto\rin0\lin0\itap0 {\fs24 
\par \sect }\sectd \sbknone\linex0\headery1440\footery1440\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 
Political science works that rely heavily on history to explain why certain decisions were made about how to regulate food or drugs, and why the system is as it is now, generally assume a monolithic decision-maker \endash  the government \endash 
 responding to outside events and reacting as any rational actor put in the government\rquote s place would act.  Thus in her book }{\i\fs24 Strategic Uses of Public Policy}{\fs24 , Donna Wood describes the \'93public outrage\'94
 hypothesis of FDA regulation.}{\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 }{\scaps\fs24 
Donna J. Wood, Strategic Uses of Public Policy:  Business and Government in the Progressive Era}{\fs24  6-9 (1986).  Despite this book\rquote s broad title, the entire work is on the regulation of }{\i\fs24 food and drugs}{\fs24  in the progressive era. }
}}{\fs24   This hypothesis explains food and drug law as a response to various events that bring problems to the government\rquote s attention.  For example, Wood evaluates the impact of Upton Sinclair\rquote s }{\i\fs24 The Jungle}{\fs24  (1905):  \'93
Theodore Roosevelt . . . sent his own blue-ribbon investigatory team to confirm Sinclair\rquote s fictional account, and the Meat Inspection Act raced through Congress and was signed by the President on June 30, 1906.\'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 }{\i\fs24 Id.}{\fs24 
 at 6.  Wood questions, however, the commonly-held notion that the Pure Food Act of 1906 (although it became law the same day) was also spurred on by }{\i\fs24 The Jungle}{\fs24 
.  She advances other reasons (consistent with the rational actor model) for its passage.  }{\i\fs24 Id.}{\fs24  at 6-7.}}}{\fs24   Likewise, the 1938 Food, Drug, and Cosmetic Act (\'93FDCA\'94) was a governmental response to the E
lixir Sulfanilamide deaths, and the 1962 amendments to that act were passed because of the phocomelia-causing drug 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 }{\i\fs24 Id.}{\fs24  at 7.}}}{\fs24   Political economist Robert Higgs runs through the same crisis-response list, although he calls this process \'93punctuated politics\'94
 instead of the \'93public outrage\'94 hypothesis.}{\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 
Robert Higgs, }{\i\fs24 Introduction}{\fs24  to }{\scaps\fs24 Hazardous to our Health?  FDA Regulation of Health Care Products}{\fs24  1, 2-3 (Robert Higgs ed., 1995).}}}{\fs24 
\par Peter Temin\rquote s }{\i\fs24 Taking Your Medicine}{\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 }{\scaps\fs24 
Peter Temin, Taking Your Medicine: Drug Regulation in the United States}{\fs24  (1980).}}}{\fs24  is a more general history than Wood\rquote 
s, and it is unique in the way he uses the history of food and drug regulation in conjunction with a psycho-social model of politics to understand FDA decision-making.  In his model Temin posits three decision-making methods.}{\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 }{\i\fs24 Id.}{\fs24 \~at 163-66.}}}{\fs24   First, the \'93instrumental\'94
 method is characterized by the definition of goals and the rational assessment of various strategies to meet those goals.  The \'93customary\'94 method, on the other hand, uses habit or tradition as the guidepost.  Finally, the \'93command\'94
 method describes the situation where the decision-maker abdicates the decision to another entity.  Furthermore, the model used by the decision-maker changes depending on the context.  To use Temin\rquote 
s own example, a perfectly healthy person maintains health (i.e., eats, sleeps, etc.) using the \'93customary\'94 method; if that person becomes mildly ill, he or she might use the \'93instrumental\'94 method in deciding what to do 
(i.e., consciously deciding whether to take a pill, stay in bed, etc.); and if that person should become seriously ill, he or she might use the \'93command\'94 method by abdicating health decisions to a doctor. 
\par \sect }\sectd \sbknone\linex0\headery1440\footery1440\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 Temin\rquote 
s model also describes three institutional structures in which decisions are made using the three decision-making methods.}{\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 }{\i\fs24 Id.}{\fs24  at 177-79.}}}{\fs24   A \'93hierarchy\'94
 exists when decision-making entities are arranged in clear power relationships where one entity gives orders and another follows them.  A \'93market\'94 exists when people or firms come together to bargain for mutually-agreeable exchanges.  A \'93
community\'94 exists when entities interact \'93informally or continually on more or less equal footing.\'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 }{\i\fs24 Id. }{\fs24 at 177.}}}{\fs24   
\par While any of the above modes of behavior can fit into any institutional str
ucture, some fits are uncomfortable.  For example, command decision-making fits rather poorly in a community relationship (where customary behavior works much better), and instrumental decision-making fits more comfortably in a market structure than it do
es in a hierarchy.}{\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 }{\i\fs24 Id.}{\fs24  at 180.}}}{\fs24 
  Temin asserts that tensions created when the institutional structure and the decision-making model do not mesh result in pressures to change the institutional structure, not the mode of behavior.}{\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 }{\i\fs24 Id.}{\fs24  at 179.}}}{\fs24   So, when personal characteristics comb
ine with unanticipated changes in the outside world to alter the average person\rquote s decision-making method, the institutional structure is pushed to transform into a structure more compatible with the behavioral mode.  
\par \sect }\sectd \sbknone\linex0\headery1440\footery1440\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 After articulating his model, Temin u
ses it to explain the history of congressional and FDA regulation he provides in the rest of the book.  For example, Temin states that \'93the Depression and the war induced a desire for more directed behavior.\'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 }{\i\fs24 Id.}{\fs24  at 198.}}}{\fs24   The increasing pace of drug discoveries (incl
uding sulfa drugs in the 1930s and antibiotics after the war) made expert guidance more necessary.  Thus, according to Temin, the 1938 FDCA was designed to establish a hierarchic structure to accommodate the growing culture of command-model decision-makin
g.}{\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 }{\i\fs24 Id.}{\fs24  at 199.}}}{\fs24 
  Temin uses his model to explicate other FDA regulatory actions and to try to determine how FDA will react to future changes.  In particular, Temin makes an important contribution to the \'93drug lag\'94
 debate by shedding light on the conflicting behavior-model assumptions underlying both sides, and he attempts to use the model to anticipate how FDA \endash  or Congress \endash 
 will respond to growing pressure (borne of increasingly instrumental consumer behavior with regard to drug selection) to speed 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 }{\i\fs24 Id.}{\fs24  at 206-15.  }}}{\fs24 
\par The
 historical works by Wood, Higgs, and Temin do not adopt the rational actor viewpoint in its purest form.  That role is fulfilled best by legislative and regulatory preambles, law casebooks, judicial decisions, or anything else that states the goals of re
g
ulation and how the current regulatory scheme achieves those goals, all of which are easy for the researcher to find.  While the rational actor model does not preclude disharmony within the government (if it did, it would be uselessly naive), it largely t
r
eats such disharmony as peripheral to the main thrust of governmental unity.  Wood and Higgs at points both ascribe importance to that disharmony.  And while Temin pays relatively less attention to disunity than the others, his model makes FDA regulation 
a
s much a product of collective psychological urges than one of rational means-ends reasoning.  Nevertheless, these historical works display a greater tendency to view food, drug, and cosmetic regulation as the product of a single-minded government reactin
g to various influences than the rest of the pieces described in this essay.
\par }\pard \ql \li0\ri0\nowidctlpar\faauto\rin0\lin0\itap0 {\fs24 
\par }\pard \ql \fi-720\li720\ri0\nowidctlpar\tx-1440\faauto\rin0\lin720\itap0 {\b\fs24 III.\tab The Organizational Process Model
\par }\pard \ql \li0\ri0\nowidctlpar\faauto\rin0\lin0\itap0 {\b\fs24 
\par \sect }\sectd \sbknone\linex0\headery1440\footery1440\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 
Most general theories of agency behavior adopt the organizational process model as their construct.  Some political scientists focus on the extent to which Congress is able to control agency behavior,}{\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 }{\i\fs24 See generally}{\fs24  Barry Weingast & Mark Moran, }{\i\fs24 Bureaucratic Discretion or Co
ngressional Control: Regulatory Policymaking by the Federal Trade Commission}{\fs24 , 91 }{\scaps\fs24 J. Pol. Econ. }{\fs24 
765 (1983) (arguing that agencies are motivated primarily by the preferences of the congressional committees that oversee them because of the rewards and sanctions those committees are capable of dispensing to the agencies); Terry Moe, }{\i\fs24 
Control and Feedback in Economic Regulation: The Case of the NLRB}{\fs24 , 28 }{\scaps\fs24 Am. J. Pol. Sci}{\fs24 . 1094 (1985) (arguing that institutional culture and superior expertise make agencies relatively independent from congressional control).}}
}{\fs24  while others pay more attention to agency responsiveness to non-governmental pressures.}{\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 Perhaps the most important of this branch of theories is the \'93capture\'94 theory advanced by George Stigler in }{\i\fs24 The Theory of Economic Regulation}{\fs24 
, }{\scaps\fs24 2 Bell J. Econ. & Mgmt. Sci. }{\fs24 2 (1971).}}}{\fs24   Since these theories explain FDA decision-making in terms of FDA\rquote s organization-level response to certa
in incentive structures imposed by various entities, and since they seem applicable regardless of personality changes at FDA, they are included in this classification.  Two political scientists in particular \endash 
 Professors Mary Olson at Yale University and Dan Carpenter at the University of Michigan \endash  are doing fascinating empirical analyses of FDA decision-making at the organizational level. 
\par One of Olson\rquote s earliest works, complaining that \'93few studies have attempted to test among the competing theories of agency behavior,\'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 }{\scaps\fs24 Mary Olson, Regulatory Agency Discretion Among Competing Industries: Inside FDA}{\fs24 
 2 (Center for American Politics and Public Policy Occasional Paper Series No. 94-4, 1994).}}}{\fs24 
 tests for determinants of FDA approval decisions in three different industries:  brand-name drugs, generic drugs, and medical devices.  The determinants for which she tests include agency budget, congressional preferences, and several mea
sures of both industry interests and consumer interests.  Her results suggest that different theories of agency behavior are \'93correct,\'94 depending on the type of product for which approval is sought.
\par \sect }\sectd \sbknone\linex0\headery1440\footery1440\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 
First, the coefficients on the FDA budget variables in all three approval categories are statistically significant, meaning that the size of FDA\rquote 
s budget affects how quickly all three regulated articles are approved.  Interestingly, the only positive coefficient for FDA\rquote s budget is in the category of generic dr
ug applications; specifically, a one percent increase in agency budget would lead to a 1.01 percent increase in the number of generic drug approvals in any given 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 }{\i\fs24 Id.}{\fs24  at 29 tbl.2a.}}}{\fs24 
  Budget constraints will not, therefore, slow the approval rate for brand-name drugs or medical devices.  Olson implies that the Pharmaceutical Manufacturers Association may have discovered this relationship earlier, explaining their attempt to limit FDA
\rquote s budget (to stifle generic drug approval) after the 1984 Drug Price Competition and Patent Term Restoration 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 }{\i\fs24 Id.}{\fs24  at 19.}}}{\fs24   
\par \sect }\sectd \sbknone\linex0\headery1440\footery1440\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 
Olson shows that congressional preferences and the public interest both affect FDA approval speed.  Olson uses the ADA}{\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 group Americans for Democratic Action (\'93ADA\'94) issues scores for all congressio
nal members based on roll calls, rating their ideology on a scale from 0 (very conservative) to 100 (very liberal).  ADA scores are widely used as a simple proxy for the political preferences of members of Congress.}}}{\fs24 
 scores of House and Senate oversight committee members to measure their preferences for more or less restr
ictive regulations for the three categories of medical technology.  The higher the ADA score for the median Senate oversight committee member, the more quickly generic drugs are approved.}{\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 }{\i\fs24 Id.}{\fs24  at 29 tbl.2a.}}}{\fs24   The same is true for House committee members and brand-name drug a
pproval.  As the median Senate oversight committee member\rquote s ADA score increases, medical devices are approved more slowly.}{\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 }{\i\fs24 Id.}}}{\fs24   As for the public interest, the death rate for brand-name drugs directly affects their approval rate, and the pharmaceutical price 
index affects the approval rate of generic 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 }{\i\fs24 Id.}}}
{\fs24 
\par \sect }\sectd \sbknone\linex0\headery1440\footery1440\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 Olson has also examined determinants of FDA
\rquote s choice of enforcement tools.}{\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 }{\i\fs24 See}{\fs24 
 Mary Olson, }{\i\fs24 Substitution in Regulatory Agencies: FDA Enforcement Alternatives}{\fs24 , 12}{\scaps\fs24  J.L. Econ. & Org. 376}{\fs24  (1996). }}}{\fs24 
  Her findings demonstrate what common sense would instruct.  For example, budget restrictions and increasing applications for product approval both result in less FDA monitoring of regulated industries and the use of \'93cheaper\'94
 enforcement tools in place of more resource-intensive 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 }{
\i\fs24 Id.}{\fs24  at 404.}}}{\fs24   Although her findings are not startling, her explanation for them is intriguing and reflects a clear organizational-process orientation.  Olson maintains that \'93
changes in FDA enforcement strategies occurred because the }{\i\fs24 political benefits}{\fs24  of pursuing high monitoring and legalistic enforcement actions diminished over time as firms\rquote , consumers\rquote , and co
ngressional preferences for more and faster FDA approvals increased.\'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 }{\i\fs24 Id.}{\fs24  at 404-05 (emphasis added).}}}{\fs24   The reason for the selection of less expensive enforcement tools, then, is not that FDA simply has less money and more work; rather, FDA changed its primary enforcement tools as a resp
onse to signals from Congress}{\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 \'93Signals\'94
 from Congress are often the most powerful mechanism for political control of an agency.  }{\i\fs24 See, e.g.}{\fs24 , Daniel P. Carpenter, }{\i\fs24  Adaptive Signal Processing, Hierarchy, and Budgetary Control in Federal Regulation}{\fs24 , 90 }{
\scaps\fs24 Am. Pol. Sci. Rev. }{\fs24 283 (1996) (arguing, without specific reference to FDA, that presidents and congressmen achieve budgetary control over a
gencies not by manipulating aggregate resource constraints but by transmitting powerful signals through budget shifts; moreover, bureaucratic hierarchy increases agency response time in processing those signals, limiting efficacy of budget manipulation as
 a control tool). }}}{\fs24  and from industry that greater political benefits would attach to certain enforcement patterns than to others.  Likewise, Olson explains regulatory tightening in response to periodic scandals not as a rational response to a n
ew problem brought to light (as do others mentioned above), but instead as FDA\rquote s response to increasing political benefits to stricter enforcement.
\par The determinants registered different effects on different FDA enforcement tools.  For example, the number of FDA inspections dropped as a result of budget cuts, but the number of FDA seizures did not.}{\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 }{\i\fs24 Id.}{\fs24  at 405.}}}{\fs24 
  Olson would posit that there must be some reason that a reduction in budget does not constitute a sufficient political incentive for FDA to reduce seizures.  Mo
re precisely, to understand agency behavior, Olson states that we must understand the internal trade-offs that result in various actions:  when FDA\rquote 
s budget is cut, what trade-offs result in a reduction in inspections but not in seizures, or an decrease in generic drug approvals but not in brand-name drug approvals?}{\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 }{\i\fs24 Id.}}}{\fs24 
\par \sect }\sectd \sbknone\linex0\headery1440\footery1440\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 
A separate study by Olson concentrates on the relationship between Congress and FDA, and more specifically on Congress\rquote  ability to constrain FDA action.}{\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 Mary Olson, }{\i\fs24 Explaining Regulatory Behavior in FDA: Political Control vs. Agency Discretion}{
\fs24 , }{\i\fs24 in }{\scaps\fs24 7 Advances in the Study of Entrepreneurship, Innovation and Economic Growth}{\fs24  71 (Gary Libecap ed., 1996).  }}}{\fs24   There are two general approaches to c
ongressional control of an agency:  ex post monitoring and ex ante administrative or procedural constraints.  Olson\rquote s study suggests that the ex ante constraints imposed by the 1962 Amendments to the FDCA limit the }{\i\fs24 direction}{\fs24 
, but not the }{\i\fs24 magnitude}{\fs24 , of agency \'93drift\'94 from congressional preferences over time.}{\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 }{\i\fs24 Id.}{\fs24  at 73.}}}{\fs24 
  FDA is effectively prevented from becoming more lenient with respect to new drug approval, but its position is not static; FDA decisions exhibit, instead, a policy shift in the direction of increased stringency.}{\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 }{\i\fs24 Id.}}}{\fs24 
  By way of contrast, FDA has fewer legislative constraints on its generic drug approval process, and there has consequently been a greater fluctuation in generic drug approval between leniency and stringency.}{\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 }{\i\fs24 Id.}}}{\fs24   Since there are fewer ex ante con
straints imposed by Congress with regard to generic drug approval, FDA is more open to political pressure (which includes ex post congressional oversight) and has more discretion to respond to that pressure.
\par Institutional culture contributes to the magnitude of FDA\rquote s drift toward stringency.}{\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 }{\i\fs24 Id.}{\fs24  at 105.}}}{\fs24 
  The professional concerns of scientists and doctors result in a preference by FDA for maintaining standards versus increasing speed.  As Olson puts it, \'93an agency staffed with doctors who are bound to the Hippocratic 
Oath will probably operate very differently than an agency staffed with lawyers or economists.\'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 }{\i\fs24 Id. }{\fs24 at 79.}}}{\fs24   Since the composition of FDA is predetermined by Congress, and since in drafting FDA\rquote 
s mandate Congress chose to focus solely on safety and efficacy instead of cost effectiveness or other non-scientific concerns, Congress\rquote  ex ante control of FDA has given that agency only one direction to move when resources are constrained.
\par \sect }\sectd \sbknone\linex0\headery1440\footery1440\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 
Congress is finding ex post oversight to be a more and more convenient way of maintain
ing political control over FDA, since any changes in the legislative status quo are practically difficult to bring about and since the informational asymmetry between Congress and FDA is at an all-time high.  But congressional oversight tends to be ineffe
ctive compared to ex ante control because the worst that can happen to FDA for deviating from congressional preferences is that its budget can be cut.}{\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 }{\i\fs24 See id.}{\fs24  at 102-03.}}}{\fs24   And as Olson has shown in other works,}{\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 }{\i\fs24 See supra}{\fs24  notes 29 and 38}{\b\fs24  }{\fs24 and accompanying text.}}}{
\fs24  such \'93agency starving\'94 only impacts some kinds of FDA behavior.  So, Olson points out, \'93
if politicians want the agency to be more responsive to industry interests, then politicians need to shift the balance of interest reflected in agency process\'94 (ex ante instead of ex post), as they did with the introduction of user fees in 1992.}{
\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 Olson, }{\i\fs24 Explaining Regulatory Behavior in FDA}{
\fs24 , }{\i\fs24 supra}{\fs24  note 40, at 106.}}}{\fs24 
\par Some of Professor Olson\rquote s more recent research suggests that congressional oversight does have important consequences, regardless of its effectiveness as a mechanism of ex post political control over 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 }{\i\fs24 See}{\fs24  Mary K. Olson, }{\i\fs24 
Agency Rulemaking, Political Influences, Regulation, and Industry Compliance}{\fs24 , 15 }{\scaps\fs24 J.L. Econ. & Org. 573}{\fs24  (1999).}}}{\fs24   While it should come as no surpris
e that heightened FDA inspection activity increases industry compliance with food and drug laws,}{\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 Specifically, a ten percent increase in aggregate inspections produces a 7.9 percent reduction in the number of firms violating FDA regulations.  }{\i\fs24 See id.}{
\fs24  at 589.}}}{\fs24  expanded congressional oversight of FDA also appears to increase industry compliance.  This is for two reasons.  First, increased congressional oversight sign
als to the industry that Congress wants food and drug safety laws to be strictly enforced.  The second reason is indirect:  greater congressional oversight leads to greater FDA inspection levels.  A ten percent increase in oversight hearings results in a 
two percent increase in FDA inspections.}{\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 }{\i\fs24 Id.}{\fs24 
 at 593.}}}{\fs24   This implies that the reduction in oversight of FDA in the early 1980s contributed to industry non-compliance, and that improved compliance in the late 1980s and early 1990s resulted at least in part from increased
 congressional oversight of FDA.
\par \sect }\sectd \sbknone\linex0\headery1440\footery1440\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 
Olson wrote one piece that indicates that the characteristics of firms regulated by FDA can serve as signals to FDA about product quality, and that FDA acts on those heuristics.}{\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 Mary Olson, }{\i\fs24 Firm Characteristics and the Speed of FDA Approval}{\fs24 , 6 }{\scaps\fs24 
J. Econ. & Mgmt. Strategy}{\fs24  377 (1997).  Olson had also argued that more specialized firms receive quicker approval, but a later work showed that this effect disappeared with the enactment of the Prescription Drug User Fee Act of 1992.  }{\i\fs24 
See}{\fs24  Mary Olson, }{\i\fs24 Regulatory Reform and Bureaucratic Responsiveness to Firms:  The Impact of User Fees in FDA}{\fs24 , 9 }{\scaps\fs24 J. Econ. & Mgmt. Strategy}{\fs24  363 (2000).  }}}{\fs24   So, all things being equal, firms with goo
d safety records can get products approved more quickly.  Professor Dan Carpenter takes this proposition a step further:  even large (and therefore familiar) firms that have historically }{\i\fs24 below-average}{\fs24 
 safety records can often get quicker approval than unknown firms.}{\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 Daniel P. Carpenter, Protection Without Capture:  Product Approval by a Politically Responsive, Bayesian Regulator 30 (2000) (working paper, on file with author at the Department of Political Science, University of Michigan).}}}{\fs24 
  This is because, as Carpenter\rquote s formal modeling shows, familiarity advantages are distinct from the firm-specific quality differentials from which FDA learns.
\par \sect }\sectd \sbknone\linex0\headery1440\footery1440\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 
Carpenter demonstrates that large firms receive regulatory \'93protection\'94 even withou
t being captured by the industry (that is, even if the regulatory action is for the benefit of consumers and not the regulated industry).  There are several reasons why a Bayesian FDA facing a stopping problem}{\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 
Political scientists refer to a decision about when to take a costly action that will be costly to undo as a \'93stopping problem.\'94  FDA faces the problem of \'93stopping\'94
 drug review only when the payoff of approval (including the avoidance of additional political costs of waiting, as with the AIDS drugs in the late 1980s) exceeds both the utility losses (including FDA\rquote s fiercely-
guarded reputation) associated with the potential danger of the drug }{\i\fs24 and the value of waiting for more information}{\fs24 
.  FDA will not, therefore, simply approve the drug when its apparent danger is less than the apparent payoff of approval, since valuable new 
information about the drug may be just around the corner.  According to Carpenter, it is this aspect of FDA decision-making that differentiates product approval from more standard problems of administrative choice.}}}{\fs24 
 would act to benefit larger, more established firms.}{\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 }{\i\fs24 
See id.}{\fs24  at 2-3.}}}{\fs24   First, larger firms have more products already on the market, so FDA will have less uncertainty about the firm\rquote 
s ability to make any safe products at all.  Second, larger firms have the capital to fill market gaps more quickly, and FDA is likely 
to respond more quickly to the heightened consumer pressure associated with a breakthrough drug.  Finally, larger firms are benefitted indirectly by FDA\rquote 
s slowness in making stopping decisions.  Larger firms have the funds to wait out a long approval process, while small companies may not, effectively protecting large firms from market entry by small ones. 
\par Carpenter\rquote s findings cast some doubt on the capture theory of agency behavior, at least as applied to FDA.  As Carpenter explains, \'93commonly adduced evi
dence for capture and rent-seeking is observationally equivalent to evidence for other models of regulation.\'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 }{\i\fs24 Id.}{\fs24  (from abstract).}}}{\fs24   In other words, while FDA actions that benefit large firms may indicate that FDA has been captured by the firms\rquote 
 superior money and organization, they may also indicate that FDA is simply a Bayesian regulator facing a stopping problem with incomplete information.  Since uncaptured (or \'93neutral\'94) agencies can thus unintentionally \'93
bequeath systematic advantages to large firms,\'94 political insulation of an agency may not, as some capture theory adherents claim, create a level playing field for firms of all sizes.}{\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 }{\i\fs24 Id.}{\fs24  at 31.}}}{\fs24 
\par \sect }\sectd \sbknone\linex0\headery1440\footery1440\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 
Carpenter focuses more on the central question of the stopping problem \endash  namely, when to decide \endash  in another work.}{\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 
Daniel P. Carpenter, Bureaucratic Choice as a Stopping Problem:  A Theoretical and Empirical Analysis of FDA Drug Review (April 1999) (paper prepared for the Midwest Political Science Association Meetings) (on file with author).}}}{\fs24 
  Indeed, as of the writing of this essay, Carpenter is the only political scientist not to view FDA decision-making as a static choice among several different policy options.  This is surprising because, as Carpenter says, \'93
the political debate over FDA drug approval concerns not }{\i\fs24 whether}{\fs24  the agency rejects or approves too many new drugs, but}{\i\fs24  how long}{\fs24  it takes for safe and efficacious drugs to get approved.\'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 }{\i\fs24 Id.}{\fs24  at 2 (emphasis in original).}}}{\fs24   Carpenter\rquote 
s empirical findings are consistent with his speculations in }{\i\fs24 Protection Without Capture}{\fs24  about why larger firms are disproportionately benefitted by FDA regulation.  
\par In particular, FDA is least likely to approve a drug precisely when Carpenter\rquote s model suggests that the value of waiting for more information is the greatest:  when the drug is first submitted.}{\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 }{\i\fs24 Id.}{\fs24  at 35.}}}{\fs24   FDA i
s not necessarily inefficient, then, even if it is slow; its decisions simply account for the value of waiting.  Second, FDA review times seem to be shortest when it is reviewing the first drug submitted for a particular disease, since political demand (g
enerated by organized consumer groups and media coverage of a disease) for the drug is strongest when no alternative exists.}{\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 }{\i\fs24 Id.}{\fs24  at 5.}}}{\fs24   The payoff for early approval is greater, the costs of waiting are lower, and the benefits of waiting are the same relative to lat
er drugs.
\par \sect }\sectd \sbknone\linex0\headery1440\footery1440\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 
Carpenter has also researched what influences the waiting costs that FDA takes into consideration when deciding when to decide.}{\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 
Daniel P. Carpenter, Groups, the Media, and Agency Waiting Costs:  The Political Economy of FDA Drug Approval (April 2000) (paper prepared for the Midwest Political Science Association Meetings) (on file with author).}}}{\fs24   He demonstrates that \'93
political influence in FDA drug approval occurs less through ideological and partisan shifts in the agency\rquote s oversight institutions (the presidency, Congress and its committees), and more through organized interests.\'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 }{\i\fs24 Id.}{\fs24  at 2.}}}{\fs24 
  Indeed, oversight committee ideology and partisanship are not correlated to a statistically significant degree with FDA review times.}{\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 }{\i\fs24 Id.}{\fs24  at 19-20.  Carpenter\rquote 
s results on ideology and partisanship are fascinating.  Although the results are statistically insignificant, a more liberal House oversight committee and a majority-Democrat Senate are both associated with }{\i\fs24 quicker}{\fs24 
 approvals. On the other hand, perhaps more in line with expectations, approvals are slower under a more liberal Senate oversight committee, a Democrat-controlled House, and Democratic presidents.}}}{\fs24 
  On the other hand, increased media coverage of a particular disease (as measured by the four-year moving average of }{\i\fs24 Washington Post}{\fs24 
 stories mentioning the disease) is highly correlated with reduced approval time for a drug relating to that 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 }{\i\fs24 Id.}{\fs24  at 21.  This confirms the speculations of journalists and historians.  }{\i\fs24 See, e.g.}{\fs24 , }{\scaps\fs24 Herbert Burkholz, FDA Follies}{\fs24 
 113 (1994).}}}{\fs24   Finally, disease-specific activists can increase FDA\rquote 
s political waiting costs.  But it is the centralization, and not the number, of such groups that counts; one group with substantial wealth is more effective than many groups with fewer 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 }{\i\fs24 Id. }{\fs24 at 24.}}}{\fs24   In sum, influences on FDA\rquote 
s waiting costs seem to be disease-specific and not systematic.
\par \sect }\sectd \sbknone\linex0\headery1440\footery1440\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 
As of the writing of this essay, Professor Carpenter, along with Professor Michael Ting, is in the process of formalizing an additional dimension to his model of FDA\rquote s stopping problem.}{\cs15\fs24\super \chftn {\footnote \pard\plain 
\ql \li0\ri0\nowidctlpar\brdrt\brdrs\brdrw15\brdrcf8 \brdrl\brdrs\brdrw15\brdrcf8 \brdrb\brdrs\brdrw15\brdrcf8 \brdrr\brdrs\brdrw15\brdrcf8 \faauto\rin0\lin0\rtlgutter\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 {\*\shppict
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\par }\pard \ql \fi720\li0\ri0\nowidctlpar\faauto\rin0\lin0\itap0 {\cs15\fs24\super \chftn }{\fs24 
Daniel Carpenter & Michael M. Ting, Product Approval with Endogenous Submissions (October 25, 2000) (working paper, on file with author).  It should be noted that formal modeling of the type done here is not for the faint of heart.  For example, \'93
comments\'94 such as these are typical:
\par }\pard \ql \li0\ri0\nowidctlpar\faauto\rin0\lin0\itap0 {\fs24 
\par 
\par 
\par 
\par 
\par }\pard \ql \li0\ri0\sa240\nowidctlpar\faauto\rin0\lin0\itap0 {\fs24 Researchers who plan to empirically test this new model, or other of Carpenter\rquote s or Olson\rquote s models with new data, should therefore have a 
solid background in at least propositional and predicate calculus. }}}{\fs24 
  Specifically, Carpenter and Ting are studying the strategic interaction between FDA and firms submitting drug applications to FDA.  This is important because a complete model of FDA decision-making requires an understanding of how firm
s will react to FDA\rquote s decision-making strategy, and how FDA will react to their reaction, and so on.
\par According to the model, once a firm has a product it thinks will be profitable, the firm must choose how much of a delay (and, therefore, how much more tes
ting) to impose on itself before seeking FDA approval.  The firm does not begin the process of deciding whether to submit or delay, under this model, until it is satisfied with its own knowledge of how safe and effective the product is.  Once FDA approval
 is sought, the model assumes the firm\rquote s knowledge of its own product\rquote s safety/efficacy level.  FDA must then decide how much additional delay and testing is needed before \'93stopping\'94
 the process and approving or rejecting the submission.  Self-delaying is c
ostly for a firm, but the longer it delays (and the more testing it does), the less likely FDA is to impose additional delay and investigation costs on the firm, and the more likely FDA is to rely on the firm\rquote 
s signals (true or false) about the quality of its product.  Ultimately, FDA would like to know what the firm knows \endash  the product\rquote s true safety/efficacy level \endash 
 but acquiring such knowledge is very costly for FDA.  This balancing act is what Carpenter and Ting formalize in their model.   
\par \sect }\sectd \sbknone\linex0\headery1440\footery1440\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 As implied above, Carpenter and Ting\rquote 
s model assumes that there are at least some products that firms would like to sell but that FDA would not approve.  If the interests of the two parties were coextensive, there would be no need for a firm to try to \'93convince\'94 FDA t
hat its product is safe and effective; the two would simply collaborate to discover the truth.  In this respect, Carpenter and Ting\rquote 
s model is comparable to regulatory models advanced by other scholars.  For example, an agency may overestimate its budgetary needs to Congress to get more money, but if it overestimates too much, it risks being audited and getting even less money.}{
\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 }{\i\fs24 See}{\fs24  Jeffrey S. Banks, }{\i\fs24 
Agency Budgets, Cost Information, and Auditing}{\fs24 , 33 }{\scaps\fs24 Am. J. Pol. Sci. 670 (1989).}}}{\fs24   The agency finds equilibrium \endash  and makes its decision \endash 
 at the point where the risk of being audited with a higher estimate outwe
ighs the possible benefit of getting more money.  Likewise, the firm submitting an application to FDA decides to submit at the very point when the costs imposed by any additional delay outweigh the possible additional benefits of signaling to FDA that suf
ficient testing has been done.  FDA decides when to decide based, in part, on those signals.
\par A useful non-empirical examination of FDA\rquote s decision-making incentives from an organizational approach is David Leo Weimer\rquote s }{\i\fs24 Organizational Incentives:  Safe \endash  and Available \endash  Drugs}{\fs24 .}{\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 }{\i\fs24 In}{\fs24  }{\scaps\fs24 
Reforming Social Regulation: Alternative Public Policy Strategies}{\fs24  19 (LeRoy Graymer & Frederick Thompson eds., 1982).  }}}{\fs24 
  While FDA might ideally outlaw only products that no fully-informed person would use, FDA has perfect information about neither the products nor the preferences or benefit-risk ratios of all the sub-populations of people it protects.}{\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 }{\i\fs24 See id.}{\fs24  at 36-39.}}}{\fs24  
 Given this lack of information, all FDA decisions must weigh in general terms the costs of keeping a product off the market against the benefits and risks of letting it on the market.  Since FDA suffers much greater political punishment for letting a dan
gerous product on the market than for keeping a useful one off, the equation is tilted toward conservatism.}{\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 }{\i\fs24 See, e.g.}{\fs24 ,}{\i\fs24  id. }{\fs24 at 21.}}}{\fs24   Much of the rest of Weimer\rquote s chapter explains in greater detail the incentives underlying FDA
\rquote s conservatism, the costs of FDA\rquote s inflexibility, and possible solutions to the problem.
\par }\pard \ql \li0\ri0\nowidctlpar\faauto\rin0\lin0\itap0 {\fs24 
\par }\pard \ql \fi-720\li720\ri0\nowidctlpar\tx-1440\faauto\rin0\lin720\itap0 {\b\fs24 IV.\tab The Bureaucratic Politics Model
\par }\pard \ql \li0\ri0\nowidctlpar\faauto\rin0\lin0\itap0 {\b\fs24 
\par \sect }\sectd \sbknone\linex0\headery1440\footery1440\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 
This section will introduce the small number of works that pay special attention to the individuals who come together to cause a particular outcome, instead of to organizational or 
governmental incentives and rationality.  This section will also briefly describe one more study by Professor Olson which, although it does not describe FDA decision-making per se, empirically analyzes the individual-level politics involved in the passage
 of the 1984 Drug Price Competition Act (\'93DPCA\'94) and the Patent Term Restoration Act (\'93PTRA\'94).  It is a useful piece for any researcher interested in the politics of pharmaceutical regulation in general and not specifically in FDA.
\par Herbert Kaufman\rquote s }{\i\fs24 The Administrative Behavior of Federal Bureau Chiefs}{\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 }{\scaps\fs24 Herbert Kaufman, The Administrative Behavior of Federal Bureau Chiefs}{\fs24  (1981).  Another valuable, but considerably older, account of the power of bureau chiefs is }{\scaps\fs24 Arthur W. Ma
cmahon & John D. Millett, Federal Administrators:  A Biographical Approach to the Problem of Departmental Management}{\fs24  (1939).}}}{\fs24 
 asserts the importance of federal bureau chiefs in bureaucratic decision-making, and he incorporates six specific leadership positions into his study (FDA commissioner among them).  Beyond making the concededl
y easy argument that bureau chiefs are important, though, Kaufman undertakes to describe how they run their agencies.  Kaufman discusses how bureau chiefs acquire, evaluate, and use information, how they handle other governmental actors, how and when they
 
delegate tasks, how and when they develop routines, how they shape the current and future operations of their agencies, and what personality qualities bureau chiefs need to succeed.  There is no chapter devoted specifically to FDA, but examples of FDA com
missioners\rquote  actions are woven throughout the book to illustrate the propositions Kaufman advances about bureau chiefs in general or to carve out exceptions to those propositions.}{\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 }{\i\fs24 See, e.g.}{\fs24 , }{\i\fs24 id.}{\fs24 
 at 162-63.  For example, one such proposition is that bureau chiefs generally desire more power and autonomy.  But 
that is not always the case.  As Kaufman explains, FDA Commissioner Donald Kennedy opposed the recommendation of the National Academy of Sciences to give FDA discretion to calculate the costs and benefits of various food additives and to devise an appropr
iate strategy for each additive.  Otherwise, the FDA commissioner would be the target of political pressure on all sides of debates on each additive.}}}{\fs24 
\par \sect }\sectd \sbknone\linex0\headery1440\footery1440\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 
The importance of the particular FDA commissioner to FDA decision-making is emphasized in a study by B. Dan Wood and Richard W. Waterman.}{\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 }{\scaps\fs24 B. Dan Wood & Richard W. Waterman, }{\i\fs24 supra }{\fs24 note 8, at 27-76.  The study was first published in B. Dan Wood & Richard W. Waterman,}{\i\fs24 
 The Dynamics of Political Control of the Bureaucracy}{\fs24 , 85 }{\scaps\fs24 Am. Pol. Sci. Rev}{\fs24 . 801 (1991).}}}{\fs24   Wood and Waterman examined the tenure of Arthur Hayes as FDA\rquote 
s commissioner.  Hayes was appointed in April 1981 by Health and Human Services (\'93HHS\'94) Secretary Richard Schweiker as part of an effort by President Reagan\rquote 
s Task Force on Regulatory Relief to speed up the new drug approval process.  As expected, FDA approved more new drugs in 1981 than it had in any year since the 1962 Amendments.}{\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 }{\i\fs24 See}{\fs24  }{\i\fs24 id}{\fs24 . at 55.}}}{\fs24   But while there was strong political support for r
educing drug approval time and cost, there was no evidence of any political support for slackening FDA\rquote s enforcement functions.}{\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 }{\i\fs24 See id.}}}{\fs24   Wood and Waterman examine whether Hayes brought such a slackening about, regardless of the lack of an executive mandate to do so.
\par \sect }\sectd \sbknone\linex0\headery1440\footery1440\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 Despite a gradual increase in FDA\rquote 
s budget throughout the early 1980s, food and drug establishment inspections declined consistently until they reached 60.22 percent below the pre-Hayes level.}{\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 }{\i\fs24 Id.}{\fs24  at 56.}}}{\fs24   Product seizures declined 43.9 percent in the first quar
ter Hayes served as FDA commissioner and remained at that level throughout the 1980s; legal actions (defined here as the sum of all prosecutions and injunctions obtained by FDA) declined by 49.6 percent in the same quarter and also remained at that level.
}{\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 }{\i\fs24 Id. }{\fs24 at 57.}}}{\fs24 
  Given these data, Wood and Waterman \'93posit a straightforward case of top agency leadership manipulating the activities of an agency.\'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 }{\i\fs24 Id.}{\fs24  at 55.}}}{\fs24   Wood and Waterman empirically establish what Kaufman deduces by observation:  the person in the FDA commissioner\rquote s, or
 HHS secretary\rquote s, seat is an important determinant of how FDA behaves.
\par Rita Campbell\rquote s }{\i\fs24 Drug Lag}{\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 }{\scaps\fs24 
Rita Ricardo Campbell, Drug Lag:  Federal Government Decision Making}{\fs24  (1976)}}}{\fs24  is perhaps the clearest example of a political science analysis of FDA using the bureaucratic politics framework.  }{\i\fs24 Drug Lag}{\fs24 
 is not a comprehensive study of FDA decision-making.  Instead, it is an account of how the various personalities inside FDA (and personalities outside FDA that had an impact on FDA) reacted to the \'93drug lag\'94
 debate, written by one of the founding members of the National Advisory Drug Committee.  Any researcher wishing to examine a microcosm of FDA decision-making from the bureaucratic politics or psychological point of view should not miss this book.
\par \sect }\sectd \sbknone\linex0\headery1440\footery1440\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 Finally, part of Mary Olson\rquote 
s Ph.D. dissertation,}{\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 Mary K.
 Olson, The Effects of Drug Regulation and the Scope for Political Influence (1991) (unpublished Ph.D. dissertation, Stanford University) (on file with University Microfilms International).  }}}{\fs24  and a later article}{\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 Mary K. Olson, }{\i\fs24 Political Influence and Regulatory Policy: The 1
984 Drug Legislation}{\fs24 , 32 }{\scaps\fs24 Econ. Inquiry 363}{\fs24  (1994).  }}}{\fs24  building on it, study why regulatory reform proposals prior to the 1984 DPCA and PTRA were stalled, and why the 1984 legislation was actually enacted.  Olson
\rquote s results demonstrate that the political preferences (represented by ADA scores and campaign contributions) of key congressional 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 
Particularly the House Subcommittee on Health and the Environment, of which Henry Waxman was chair, and the Senate Committee on Labor and Human Resources, of which Orrin Hatch was chair.}}}{\fs24 
 members favored the status quo over any proposed bills before 1984, and that changes in House committee and subcommittee membership combined with a change in party control of the Senate to create a mix of political preferences that i
nstead favored reform over the status quo.  Olson explains that \'93as membership and preferences on these committees change over time, the set of policies which can be supported by a majority on the committee will also change.\'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 }{\i\fs24 Id.}{\fs24  at 381.}}}{\fs24   Olson\rquote s results also show th
at, while the wishes of a subcommittee chair (particularly, in this case, Henry Waxman) can be stymied by the other subcommittee members, the chair (in addition to being able to prevent bills from reaching the floor) can influence the composition of the s
ubcommittee over time, bringing the subcommittee more in line with his or her preferences.
\par }\pard \ql \li0\ri0\nowidctlpar\faauto\rin0\lin0\itap0 {\fs24 
\par }\pard \ql \fi-720\li720\ri0\nowidctlpar\tx-1440\faauto\rin0\lin720\itap0 {\b\fs24 V.\tab Miscellaneous Works
\par }\pard \ql \li0\ri0\nowidctlpar\faauto\rin0\lin0\itap0 {\b\fs24 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 {\fs24 Three political science pieces would fit so awkwardly into any one of the three models that to force them to do so would be more misleading t
han helpful.  These works explore the operations of FDA using more than one framework, and would be useful references no matter what lens the future researcher uses to examine FDA.
\par \sect }\sectd \sbknone\linex0\headery1440\footery1440\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 Paul Quirk\rquote 
s chapter on FDA in James Q. Wilson\rquote s }{\i\fs24 The Politics of Regulation}{\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 Paul J. Quirk, }{\i\fs24 Food and Drug Administration}{\fs24 , }{\i\fs24 in }{\scaps\fs24 The Politics of Regulation 191}{\fs24  (James Q. Wilson ed., 1980).  }}}{\fs24 
 is perhaps the single most indispensable political science piece on FDA, and certainly one of the most cited.  In this chapter, Quirk analyzes the politics of drug legislation in 1906, 1938, and 1962, claiming that the enactment of these laws depended o
n the overall political climate and was not necessarily intended to benefit the industry, even though the industry supported 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 }{\i\fs24 Id. }{\fs24 at 201.  }}}{\fs24   Quirk\rquote 
s telling of the history of drug legislation is notable in that it is centered on politics and not on policy; individuals are vital to Quirk\rquote 
s account.  Despite the politics orientation, however, Quirk includes discussion of the policy dilemmas inherent in drug regulation.
\par Quirk reviews internal (especially personnel) factors that account for FDA behavior.  For example, Quirk explains that since FDA medical officers \'93do little creative research; instead, they evaluate research submitted by drug companies,\'94
 FDA often has trouble recruiting top minds.}{\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 }{\i\fs24 Id.}{\fs24 
 at 207.}}}{\fs24   Salary and working conditions at FDA are also not comparable to what physicians can get in private practice.  Managerial problems plagued the Bureau of Drugs in the late 1960s and early 1970s, and internal conflict has hindered FDA
\rquote s drug approval policy.}{\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 }{\i\fs24 Id.}{\fs24  at 207-08.}}
}{\fs24   If FDA is slow or inefficient, then, it is partly because of the people there and not because of the agency\rquote s incentives or the laws governing FDA.
\par \sect }\sectd \sbknone\linex0\headery1440\footery1440\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 
Quirk also discusses in some detail several external factors that influence FDA decision-making, such as industry lobbying, consumer groups, public opinion, and congressional oversight.  Quirk even tells one tale (calling it the \'93
exception that proves the rule\'94) of attempted political intervention on behalf of a drug:  when FDA declared the combination antibiotic Panalba ineffective, the Upjohn Company convinced HEW Secretary Robe
rt Finch to order FDA to grant Upjohn a hearing, but Finch\rquote s order was quickly reversed by the House Committee on Government Operations.}{\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 }{\i\fs24 Id.}{\fs24  at 212.}}}{\fs24   Presaging the Wood and Waterman study, Quirk also points to presidential influence through high-level FDA appointments.}{
\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 }{\i\fs24 Id.}{\fs24  at 217.}}}{\fs24 
  Finally, Quirk remarks that the balance of all these external influences \'93
fluctuates with events, with the rise and decline of social movements and political organizations, with experience of the impact of previous regulatory decisions, and with broad changes of public attitude.\'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 }{\i\fs24 Id.}{\fs24  at 218.}}}{\fs24 
\par \sect }\sectd \sbknone\linex0\headery1440\footery1440\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 Stephen Ceccoli\rquote s Ph.D. dissertation}
{\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 
Stephen J. Ceccoli, The Politics of New Drug Approvals in the United States and Great Britain (1998) (unpublished Ph.D. dissertation, Washington University) (on file with the Harvard Law School Library).  }}}{\fs24 
 offers a fascinating comparative political science approach to drug regulation in the United States.  Much of the dissertation adopts a rational actor view of American drug regulation.  
Chapter 2, for example, is aimed at showing that the differences between American and British political institutions themselves explain variation in the political responsiveness of the drug regulatory agencies as well as in the attitudes of regulatory off
icials.  Nevertheless, an organizational process framework is evident in Ceccoli\rquote s discussion of FDA\rquote 
s recent shift away from its single-minded protection of the consumer to its dual role of consumer protection and promotion of new medical treatments through quick drug approval; FDA\rquote s \'93regulatory shift\'94
 was due to pressures from the anti-regulatory Reagan and Bush administrations, consumer groups (particularly AIDS groups), and the pharmaceutical 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 }{\i\fs24 Id}{\fs24 . at 248-57.}}}{\fs24   Making the categorization of this work particularl
y difficult is that Ceccoli consistently uses four factors in his analysis of regulatory behavior:  history and path dependence (the effect of the past and of routine on current practice), the degree of goal consensus or controversy (i.e., the clarity of 
the legislative mandate), the level of political support the agency gets, and nature of the relationship between the regulated industries and the agency.  For the future researcher, Ceccoli\rquote 
s dissertation also contains an excellent bibliography of government documents related to the study of FDA.
\par A general work that serves as a good introduction to theories of regulatory politics in general and to FDA behavior in particular is Sidney Shapiro and Joseph Tomain\rquote s}{\scaps\fs24  }{\i\fs24 Regulatory Law and Policy}{\fs24 .}{\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 }{\scaps\fs24 Sidney A. Shapiro & Joseph P. Tomain, Regulatory Law and Policy}{
\fs24  (1998).}}}{\fs24   It is structured like a casebook in that it contains excerpts from other sources followed by notes and questions.  Chapter 3, \'93Regulation and Politics,\'94
 provides a strong theoretical anchor for political science research on agency decision-making.  Chapter 11 contains a cas
e study of FDA, including history, policy justifications for current drug law, and passages from scholarly debates on whether FDA should allow very ill people to access drugs even if FDA has not approved them.  The notes and questions to the case study pr
ovide a good discussion of the policy debates involved in new drug approval.
\par }\pard \ql \li0\ri0\nowidctlpar\faauto\rin0\lin0\itap0 {\fs24 
\par }\pard \ql \fi-720\li720\ri0\nowidctlpar\tx-1440\faauto\rin0\lin720\itap0 {\b\fs24 VI.\tab Conclusion
\par }\pard \ql \li0\ri0\nowidctlpar\faauto\rin0\lin0\itap0 {\b\fs24 
\par \sect }\sectd \sbknone\linex0\headery1440\footery1440\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 
The current state of the political science literature on FDA is easy to describe because it has few internal conflicts.  Not surprisingly, FDA decision-making is 
influenced by a number of factors, including congressional preferences (as manifested by, among other things, oversight activity and budget manipulation), presidential preferences, personalities in FDA, agency incentives, and, in some circumstances, FDA
\rquote s budget itself.  The weight of various factors depends on which industry is being affected and what type of decision \endash  i.e., when a decision is made or what the decision itself was \endash 
 is being examined.  The real use of a political science analysis of FDA is
 in understanding which factors tend to matter most in a particular situation, and how they will bring their influence to bear, and why.  The ultimate goal is the ability to predict what will happen given a specific set of circumstances; that is why polit
ical science has even the smallest of claims to the term \'93science.\'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 inability to make consistently }{\i\fs24 accurate}{\fs24  predictions does not undermine the pursuit\rquote s status as a science; astrophysics has historically had this problem, and meteorology still does.}}}{\fs24 

\par As should be clear from this essay, the political science literature on FDA exhibits a great variety.  Nevertheless, it has notable gaps.  First, nearly all of the empirical work and the v
ast majority of the work in general focuses primarily on drug regulation.  The field would benefit tremendously from a study of FDA decision-making regarding other FDA-regulated industries such as food, cosmetics, or animal feed.  Second, while political 
s
cience works using the rational actor model or the organizational process model are relatively easy to come by, fewer FDA-specific works adopt the bureaucratic politics model, and even fewer examine FDA politics at the individual level beyond the post of 
F
DA commissioner.  This is, at least in part, due to the informational problems associated with describing the decision-making process using that framework:  not only must such a description be intensely fact-specific and therefore limited both in scope an
d
 in broader application, but the relevant facts are also very difficult to discover for anyone but FDA insiders.  While the organizational process model might be the most convenient analytical lens through which to examine FDA, the study of FDA decision-m
aking could use more carefully researched, individual-level accounts of important FDA decisions.
\par \sect }\sectd \sbknone\linex0\headery1440\footery1440\sectdefaultcl \pard\plain \ql \fi720\li0\ri0\sl480\slmult1\nowidctlpar\faauto\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 
The future researcher can take some comfort in the bibliographical completeness of this essay as of the time it was written, but he or she should remember that it is \'93complete\'94
 only to the extent that it covers the limited category of political science research (defined narrowly) specifically on FDA.  There are numerous political science works on health care regulation or on the bureaucracy in general, and there
 are literally thousands of books and articles not mentioned here that touch on some aspect of FDA.  Economics, history, law, psychology, biochemistry, and other disciplines can, of course, contribute to the study of how FDA decides \'93
who gets what, when, and how,\'94 or of \'93how goals [are] determined, conflict resolved or managed, standards set, and policy enforced.\'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 Wilson, }{\i\fs24 supra}{\fs24  note 85, at xi.}}}{\fs24   While there is \endash  and ought to be \endash 
 a porous barrier between disciplines that examine a common target, some segregation, however debatable the dividing line, is necessary lest any survey span the entire web of human knowledge.
\par }}