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Never Waste a Crisis: The Past, Present, and Future of FDA Reform
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DOI：10.1215/03616878-12262664.png)
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Abstract
En 中文
A core mission of the US Food and Drug Administration (FDA) is to advance public health through regulatory decision-making, demanding both scientific expertise and political judgment. Since its inception, the FDA has undergone frequent reform intended to better position the agency to fulfill its mission with attention to evidentiary standards, patient autonomy and protection, innovation and access, transparency, and independence. The FDA is situated within the executive branch, so it is reasonable for the agency's priorities and approach to change with administrations. However, the scope, number, and magnitude of changes in the second Trump administration have been extraordinary, including tremendous loss of expert staff and leadership, proposals for rushed reviews and approvals based on little evidence, expert panels lacking public input and conflict-of-interest vetting, and political interference in lieu of established science and procedures. Scientific rigor and public trust in the FDA's decisions are at stake. Yet this crisis may offer an opportunity to rebuild and reenvision the FDA for the future. This article proposes that developing a core set of principles and associated metrics can shape rebuilding and reform by providing a framework for guiding FDA policy choices, a shared evaluative structure for assessing agency actions, and parameters for differentiating reasonable policy changes from unreasonable ones.
Keywords:
FDA
public health
pharmaceutical policy
Journal
J
IF:
2.8
Papers:
2.5K
Citations:
1.4K
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Cited Papers