The Mifepristone Litigation: Untangling the Implications of the Fifth Circuit's Decision for Abortion Access and the US Food and Drug Administration

In August 2023, a federal appeals court issued an opinion in Alliance for Hippocratic Medicine v FDA, a case wherein a group of antiabortion medical organizations and physicians have challenged U.S. Food and Drug Administration (FDA) approval and regulation of mifepristone. This opinion contained some good news for the FDA, drug makers, and patients: the appeals court declined to halt the marketing of mifepristone altogether (as the trial court judge would have). But the court also decided that the FDA's 2016 and 2021 actions expanding the indication for mifepristone, lowering the drug's dose, and loosening restrictions on its distribution and use were likely unlawful, and it thus affirmed the trial court's order staying these actions. In this article, we explain key aspects of the opinion to health care professionals and consider the ways in which the appeals court's reasoning and conclusions, if followed by the Supreme Court, could undermine abortion access and public health going forward.

Automated summary

This article discusses the opinion issued by the federal appeals court in the case of Alliance for Hippocratic Medicine v FDA, and its impact on the approval and regulation of mifepristone. The appeals court did not completely halt the marketing of mifepristone, but it deemed the FDA's actions in 2016 and 2021 potentially unlawful and affirmed the order to stay these actions.