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

• 成果类型: Article
• 署名作者: Lavertu, Stephane; Weimer, David L.
• 署名单位: University of Colorado System; University of Colorado Boulder; University of Wisconsin System; University of Wisconsin Madison
• 刊物名称: JOURNAL OF PUBLIC ADMINISTRATION RESEARCH AND THEORY
• ISSN/ISSBN: 1053-1858
• DOI: 10.1093/jopart/muq046
• 发表日期: 2011
• 页码: 211-237
• 关键词: politics; performance; science

摘要

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.