FDA v. Alliance for Hippocratic Medicine

FDA v. Alliance for Hippocratic Medicine Danco Laboratories, L.L.C. v. Alliance for Hippocratic Medicine[note 1]
Supreme Court of the United States
Argued March 26, 2024 Decided June 13, 2024
Full case name	Food and Drug Administration, et al.; v. Alliance for Hippocratic Medicine, et al.
Docket nos.	23-235 23-236
Citations	602 U.S. 367 (more)
Argument	Oral argument
Case history
Prior	All. for Hippocratic Med. v. U.S. Food & Drug Admin., 78 F.4th 210.
Questions presented
Whether respondents have Article III standing to challenge FDA's 2016 and 2021 actions. Whether FDA's 2016 and 2021 actions were arbitrary and capricious. Whether the district court properly granted preliminary relief.
Holding
Plaintiffs lack Article III standing to challenge FDA’s actions regarding the regulation of mifepristone.
Court membership
Chief Justice John Roberts Associate Justices Clarence Thomas · Samuel Alito Sonia Sotomayor · Elena Kagan Neil Gorsuch · Brett Kavanaugh Amy Coney Barrett · Ketanji Brown Jackson
Case opinions
Majority	Kavanaugh, joined by unanimous
Concurrence	Thomas

Food and Drug Administration v. Alliance for Hippocratic Medicine, 602 U.S. 367 (2024), was a United States Supreme Court case to challenge the U.S. Food and Drug Administration (FDA)'s approval of mifepristone, a drug frequently used in medical abortion procedures. The plaintiffs, led by the Alliance for Hippocratic Medicine (AHM), argued that the FDA did not properly approve the use of the drug mifepristone for pregnancy termination under Federal Food, Drug, and Cosmetic Act regulations and asked for an injunction to withdraw the drug's approval, thus removing it from the market. AHM's suit followed the Supreme Court's ruling in Dobbs v. Jackson Women's Health Organization in 2022, which reversed Roe v. Wade and asserted there was no constitutional right to abortion at the federal level, leading conservative states and groups to further restrict abortion access.

District Judge Matthew J. Kacsmaryk issued a preliminary injunction suspending the approval of mifepristone on April 7, 2023; on appeal by the government to the Fifth Circuit, the Fifth Circuit partially reverted Kacsmaryk's injunction, allowing the drug's 2000 approval to stand, but putting on hold changes to the FDA's distribution rules on the drug that were put in place in 2016, including distribution by mail. A separate Washington federal district judge also issued on April 7, 2023, a separate injunction forcing the FDA to maintain the distribution of mifepristone in 16 states and the District of Columbia. On April 13, that judge issued another order, purporting to force FDA to maintain approval regardless of the Texas or Fifth Circuit ruling.

The Supreme Court of the United States ruled unanimously on June 13, 2024 that the Alliance did not have association standing under Article III to bring a case, since neither AHM nor the groups it represented had shown injury. The decision reversed the lower court decisions, restoring mifepristone's availability under current FDA rules.
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