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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. 联邦咨询委员会、专家政见和食品药物管理局的医药审批 摘要 美国联邦政府的决策者们经常听取联邦咨询委员会(Federal Advisory Committees)的政策建议。而对于咨询委员会如何影响行政决策,我们还缺乏足够的系统研究。本文分析美国联邦食品药物管理局 (FDA) 在审批药品和医疗设备入市的过程中如何采用咨询委员会的建议。我们首先采用1997年到2006年的药品和医疗设备的审批数据来估算咨询委员会对于药品审批通过率的影响。我们发现, 增加咨询委员会成员参与投票决策的比重,会提高药品审批通过的机率和缩短审批的时间。其次,基于理论和实证研究的考虑,我们探讨了食品药物管理局向咨询委员会寻求建议的决定,以及这个咨询过程可能导致的(决策)延迟。尽管我们仅有审批药品申请的数据来讨论后两个问题,我们的研究结果还是具有广泛意义的。我们的分析有助于未来更好的研究咨询委员会提供政策咨询,探讨行政拖延,以及讨论如何对行政进行政治监管。
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