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December 15, 2023
Health Law Weekly

U.S. Supreme Court to Review Ruling Limiting Abortion Pill Access

  • December 15, 2023
Supreme Court building

The U.S. Supreme Court agreed December 13 to review a Fifth Circuit decision that the Food and Drug Administration (FDA) improperly lifted certain restrictions on the abortion pill mifepristone that expanded access to the drug.

The panel ruling in August had no immediate impact on the availability of mifepristone since the Supreme Court previously ordered that the status quo under existing regulations remain while the litigation played out.

The government petitioned the Court to weigh in on the consequential issue, which follows in the wake of its decision in June 2022 overturning Roe v. Wade.

The FDA approved the brand-name version of mifepristone in 2000 for medical termination of pregnancy up to seven weeks. In 2016, the FDA extended the drug’s availability through ten weeks gestation among other changes. The agency further loosened restrictions on the drug in 2021 during the COVID-19 pandemic, including allowing mifepristone to be delivered by mail. Mifepristone and a second drug misoprostol account for about half of abortions nationwide.

The Fifth Circuit partially reversed a ruling in April by U.S. District Court for the Northern District of Texas Judge Matthew J. Kacksmaryk that granted a preliminary injunction to plaintiff doctors and medical associations who argued the FDA’s fast-track approval of the drug ignored safety concerns and was politically motivated. See Alliance for Hippocratic Med. v. U.S. Food and Drug Admin., No. 2:22-CV-223-Z (N.D. Tex. Apr. 7, 2023).

The appeals court panel held that the challenge to the 2000 approval was untimely but also found that plaintiffs sufficiently demonstrated injuries for standing purposes, including requiring the physician challengers to perform or complete an abortion contrary to their sincerely held beliefs as part of treating women suffering from mifepristone complications, to challenge the FDA’s regulatory action regarding the drug in 2016 and 2021. The appeals court then concluded that the FDA likely violated the Administrative Procedure Act when it lifted certain restrictions for mifepristone. Alliance for Hippocratic Med. v. Food and Drug Admin., No. 23-10362 (5th Cir. Aug. 16, 2023).

At the time of the panel’s ruling, however, the Supreme Court had already stayed the injunction pending resolution of the appeal and disposition of any petition for writ of certiorari.

The Court also agreed to review, as a consolidation action, an appeal of the ruling by Danco Laboratories, LLC, which manufactures Mifeprex, the brand-name version of mifepristone. The Court declined, however, to consider another petition asking it decide whether the FDA's original approval of the drug should be overturned. 

Food and Drug Admin. v. Alliance for Hippocratic Med., No. 23-235, and Danco Labs., L.L.C. v. Alliance for Hippocratic Medicine, No. 236 (U.S. cert. granted Dec. 13, 2023).