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FDA Decisions and Public Deliberation:Challenges and Opportunities
Author(s) -
Gusmano Michael K.
Publication year - 2013
Publication title -
public administration review
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.721
H-Index - 139
eISSN - 1540-6210
pISSN - 0033-3352
DOI - 10.1111/puar.12121
Subject(s) - deliberation , legitimacy , bureaucracy , public relations , politics , food and drug administration , administration (probate law) , public administration , political science , business , process (computing) , executive branch , law , risk analysis (engineering) , computer science , operating system
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 .