On August 16, a three-judge panel of the U.S. Court of Appeals for the Fifth Circuit ruled on the appeal in the case challenging the FDA approval of mifepristone, one of the two drugs used to cause a medication abortion. The opinion declined to invalidate the original approval of the drug, but upheld the district court’s rejection of more recent actions by the FDA to expand access to the medication.
To recap the underlying litigation, the Alliance for Hippocratic Medicine and other plaintiffs had filed for a preliminary injunction against the FDA approval in the U.S. District Court for the Northern District of Texas in November 2022, challenging the initial FDA approval in 2000 as well as the agency’s relaxation of safety restrictions in 2016 (the 2016 Changes), approval of a generic version of the drug in 2019 (the 2019 Generic Approval), and announcement in 2021 that it would exercise enforcement discretion by allowing the drug to be dispensed through the mail (the 2021 Actions). In April 2023, the district court had granted the plaintiff’s motion in part by staying the FDA approval of mifepristone and its subsequent actions. On April 21, 2023, the U.S. Supreme Court stayed the district court’s order from going into effect pending disposition of the appeal.
The Fifth Circuit decision vacated the district court’s ruling against the FDA’s approval of the drug in 2000 on the grounds that the challenge is probably barred by the statute of limitations. The decision also vacated the ruling against the 2019 Generic Approval because the plaintiffs failed to show they were injured by it. Those parts of the decision would keep mifepristone and the generic version on the market. The panel, however, affirmed the district court’s order staying the 2016 Amendments relaxing some of the initial safety restrictions and the 2021 non-enforcement decision to allow dispensing through the mail. This decision will not change anything given the Supreme Court’s April order, but it will define the arguments that will likely be presented when the case is appealed to the Supreme Court.