Never Waste a Crisis: The Past, Present, and Future of FDA Reform.

A core mission of the US Food and Drug Administration is to advance public health through regulatory decision-making, demanding both scientific expertise and political judgment. Since its inception, FDA has undergone frequent reform intended to better position the agency to serve its mission, with attention to evidentiary standards, patient autonomy and protection, innovation and access, transparency, and independence. Situated within the executive branch, it is reasonable for FDA's priorities and approach to change from administration to administration. 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. At stake are scientific rigor and public trust in FDA's decisions. Yet this crisis may offer an opportunity to rebuild and reenvision FDA for the future. We propose 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 from unreasonable policy changes.