The Supreme Court granted a temporary stay that allows mifepristone to continue being dispensed by mail as a legal challenge unfolds, pausing a Fifth Circuit order set to take effect on May 1, 2026 that would have reinstated an in-person dispensing requirement.
The court's action came in a brief, one-paragraph order that acceded to requests from manufacturers Danco Laboratories and GenBioPro Inc. The stay preserves existing distribution practices while the Fifth Circuit appeal proceeds and during any subsequent petition for certiorari to the Supreme Court.
Louisiana is the party pressing the challenge, targeting the Food and Drug Administration's decision made during President Joe Biden's administration to allow remote prescriptions and mailing of the abortion pill mifepristone. The Fifth Circuit had issued an order that, absent intervention, would have required patients to obtain the drug in person.
Two justices dissented from the stay. Justice Clarence Thomas issued a dissent asserting that the manufacturers were part of a "criminal enterprise" and contending they should not receive relief for lost profits tied to alleged violations of the Comstock Act, which prohibits mailing drugs intended to produce abortions. Justice Samuel Alito also dissented, writing that the litigation was part of a "scheme to undermine our decision in Dobbs v. Jackson Women’s Health Organization," referencing the 2022 ruling that overturned the constitutional right to abortion.
The FDA removed the in-person dispensing mandate for mifepristone in 2023, having earlier adopted a nonenforcement policy in 2021. Following the 2023 change, the Secretary of Health and Human Services conceded that the FDA had not sufficiently weighed patient safety when approving the revised dispensing policy and announced a study to evaluate whether the changes remain appropriate.
The stay will stay in place while the Fifth Circuit appeal is pending and throughout any period in which a certiorari petition is under consideration. According to the court's order, if the Supreme Court declines to grant certiorari, the stay will terminate automatically. If certiorari is granted, the stay will remain until the Supreme Court issues its judgment.
Key points
- The Supreme Court issued a one-paragraph stay permitting mail distribution of mifepristone while appeals continue.
- The stay responds to requests from Danco Laboratories and GenBioPro Inc. and halts a Fifth Circuit order that would have reinstated an in-person dispensing requirement effective May 1, 2026.
- Justices Clarence Thomas and Samuel Alito dissented, citing alleged criminality and a claim the case seeks to undermine Dobbs.
Risks and uncertainties
- Legal uncertainty - Outcome depends on the Fifth Circuit appeal and any Supreme Court review, creating ongoing regulatory risk for pharmaceutical distribution and health care providers.
- Regulatory review - The Secretary of Health and Human Services has signaled potential reassessment of the FDA's 2023 policy due to patient safety considerations, which could affect dispensing rules and industry compliance obligations.