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Image of Federal Advisory Committees, Policy Expertise, and the Approval of Drugs and Medical Devices at the FDA

Journal Articles

Federal Advisory Committees, Policy Expertise, and the Approval of Drugs and Medical Devices at the FDA

Lavertu, Stéphane - Personal Name; Weimer, David L. - Personal Name;

Policy makers in the US federal government regularly consult advisory committees, but there is little systematic research on how committee advice influences executive branch policy making. We investigate the Food and Drug Administration's (FDA) use of advisory committees when deciding whether or not to approve pharmaceutical drugs and medical devices for marketing. Specifically, using 1997–2006 drug and device approval data, we estimate the influence of committee advice on FDA decision making. We find that an increase in the proportion of committee members voting for drug approval increases the probability of FDA approval and that an increase in the proportion of committee members voting for approval reduces the time it takes for the FDA to approve a drug or device application after committee consultation. Additionally, for theoretical and empirical reasons, our analysis explores the FDA's decision to consult advisory committees and its concern about the delay that committee consultation might introduce. Although data limitations enable us to explore these latter issues with respect to approved applications only, our study has some implications for scholarship on committee consultation, bureaucratic delay, and political control.


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Detail Information
Series Title
Journal of Public Administration Research and Theory
Call Number
-
Publisher
Oxfordshire, United Kingdom : Oxford University Press., 2011
Collation
-
Language
English
ISBN/ISSN
10531858
Classification
-
Content Type
-
Media Type
-
Carrier Type
-
Edition
Vol. 21, Number 2, April 2011.pp. 211-237
Subject(s)
United States
Federal Government
Federal Advisory Committees, Policy Expertise
Specific Detail Info
-
Statement of Responsibility
-
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Kemitraan Library
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Established in 2003, the Library of Kemitraan was originally designed to record and collect all Kemitraan and grantees publications. However, today it broadly develops and serves more sectors to expand the collection to facilitate research activities, particularly since the inception of the Knowledge and Research Management within Kemitraan.

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