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Health and the 2024 US Election
June 18, 2024

Checks and Balances on FDA鈥檚 Authority

Author Affiliations
  • 1Perelman School of Medicine and Carey Law School, University of Pennsylvania, Philadelphia
  • 2Center for Science in the Public Interest, Washington, DC
  • 3Harvard Law School, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard University, Cambridge, Massachusetts
JAMA. 2024;332(9):705-706. doi:10.1001/jama.2024.11987

In March 2024, the US Supreme Court heard arguments in Food and Drug Administration (FDA) v Alliance for Hippocratic Medicine (AHM). The case, decided in FDA鈥檚 favor in June, involved a challenge to a series of FDA decisions that loosened restrictions on mifepristone the agency deemed unnecessary to the safety of patients pursuing medication abortion. One of the central issues in the case was whether the antiabortion physicians who sued FDA had legal 鈥渟tanding鈥 to do so. Standing refers to whether a plaintiff has or will imminently suffer a concrete injury to a legal interest caused by the defendant's actions that could be redressed by judicial intervention. Addressing the government鈥檚 assertion that AHM lacked standing because its members had not used or prescribed mifepristone, Justice Clarence Thomas asked the US solicitor general during oral argument: 鈥淸C]ould you give us an example of who would have standing to challenge鈥hese FDA actions?鈥1 Justice Samuel Alito pressed harder, asking, 鈥淪o your argument is that it doesn鈥檛 matter if FDA flagrantly violated the law,鈥ndangered the health of women, it鈥檚 just too bad, nobody can sue in court?鈥he American people have no remedy for that?鈥1

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