The political economy of FDA drug review: Processing, politics, and lessons for policy
The political economy of FDA drug review: Processing, politics, and lessons for policy
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DOI：
10.1377/hlthaff.23.1.52
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发表时间：
2004-01-01
期刊：
影响因子：
9.7
通讯作者：
Carpenter, DP
中科院分区：
文献类型：
--
作者：
Carpenter, DP
美国食品和药物管理局（FDA）的药物审查与其他监管机构的许多决策具有结构上的相似性：高不确定性、低可逆性、避免可观察到的错误，以及引起利益相关方游说的高政治风险。本文探讨了在信息处理过程中，将FDA药物审查视为一种政治塑造的做法所应吸取的政策教训。我认为，监管机构面临的激励措施限制了药物审查加速的程度，同样的激励措施可能使私有化计划出现问题，政治压力可能在确定优先药物方面发挥有益的作用。
U.S. Food and Drug Administration (FDA) drug review bears a structural similarity to many decisions made by other regulatory agencies: high uncertainty, low reversibility, avoidance of observable error, and high political stakes that induce lobbying by interested parties. This paper explores the policy lessons to be learned from viewing FDA drug review as a politically shaped exercise in information processing. I argue that the incentives facing regulators induce limits on the degree to which drug review can be accelerated, that the same incentives could render privatization initiatives problematic, and that political pressures could play a useful role in identifying priority drugs.