FDA v. Alliance for Hippocratic Medicine and the Future of Mifepristone Access

Journal

Fertility & Sterility

Abstract

Mifepristone and misoprostol comprise the FDA-approved two-drug medical abortion regimen that is currently the primary method by which pregnant Americans access abortion. These two drugs are also often used in combination off-label for miscarriage care. On June 13, 2024, in FDA v. Alliance for Hippocratic Medicine, the Supreme Court of the United States issued a unanimous decision, holding against a conservative physicians’ organization that was seeking to increase the barriers to obtaining mifepristone or to withdraw the drug from the market altogether. Rather than reaching the merits of the dispute, the Court decided that the challengers lacked “standing” – the ability to be a proper plaintiff to bring the case -- in the first place. The organization formally withdrew its claims in November 2024. Consequently, at least for the time being, physicians will not have to rely on misoprostol alone for abortion and miscarriage care. Nevertheless, the future availability of mifepristone remains precarious; the courts or the incoming Trump administration could still inhibit or even block access to the drug. In this Commentary, we explain the Supreme Court’s decision, its impact on the longer course of the litigation, and why litigation and executive branch threats to mifepristone remain.

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