FDA Decisions and Public Deliberation:Challenges and Opportunities

• 成果类型: Article
• 署名作者: Gusmano, Michael K.
• 刊物名称: PUBLIC ADMINISTRATION REVIEW
• ISSN/ISSBN: 0033-3352
• DOI: 10.1111/puar.12121
• 发表日期: 2013
• 页码: S115-S126
• 关键词: health technology-assessment; DELIBERATIVE DEMOCRACY; DRUG; disclosure; deadlines; food

摘要

The responsiveness of the bureaucracy to political control is a long-standing issue for scholars in public administration. The legitimacy of decisions made by the bureaucracy often depends on the technical merits of these decisions, but deliberative decision making involving a broad array of relevant stakeholders offers another potential source of legitimacy for executive agencies. In this article, the author examines efforts to expand the role of the public in decision making at the U.S. Food and Drug Administration (FDA). The claim that patients and consumers should have a voice in FDA decisions is important, but it does not tell us how much influence they should have or what decisions require their input. Calls for creating a deliberative process for regulatory decision making are ubiquitous, but they are not likely to succeed unless agencies pay close attention to the challenge of doing this well.