NEJM March 11, 2023
C. Joseph Ross Daval, J.D., Liam Bendicksen, B.A., and Aaron S. Kesselheim, M.D., J.D., M.P.H.

The legal foundation on which the authority of the Food and Drug Administration (FDA) rests is shifting. Since 1984, the FDA has conducted its oversight of prescription drugs, medical devices, and other products with deference from courts enshrined by a landmark Supreme Court case, Chevron U.S.A. v. Natural Resources Defense Council. But mounting judicial skepticism of agency authority, which reached a new height in the 2022 case West Virginia v. Environmental Protection Agency (EPA), has weakened this norm and now threatens to upend it. Congress and the FDA may have to adapt with more frequent, narrow regulation to continue to defend the quality and reliability of medical products.

To accomplish complex, ongoing tasks, Congress has often delegated power to regulatory...

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