Health Law Daily Wrap Up, DRUGS AND BIOLOGICS—U.S.: Supreme Court extends stay preserving mail access to mifepristone through May 14, (May 12, 2026)

By Sheila Lynch-Afryl, J.D., M.A.

The Court initially stayed the Fifth Circuit’s decision through May 11.

After receiving the federal government’s response and numerous amicus briefs, the U.S. Supreme Court extended its stay preserving mail access to mifepristone for three days, through 5 p.m. on Thursday, May 14. The Court’s May 4 order initially stayed the Fifth Circuit’s decision—which stayed the FDA’s 2023 removal of the in-person dispensing requirement from mifepristone’s Risk Evaluation and Mitigation Strategy (REMS) pending appeal—through May 11. On May 14 the Court could allow the administrative stay to expire, leaving the Fifth Circuit’s decision in place, but it’s more likely to accept the case (Danco Laboratories, LLC v. Louisiana, No. 25A1207 (U.S. May 11, 2026); GenBioPro, Inc. v. Louisiana, No. 25A1208 (U.S. May 11, 2026)).

This case stems from a lawsuit filed by Louisiana and a private plaintiff, who challenged under the Administrative Procedure Act (APA) the FDA’s removal of the in-person dispensing requirement in 2023. The district court allowed Danco Laboratories, LLC, the manufacturer of Mifiprex, and GenBioPro, Inc., a manufacturer of generic mifepristone, to intervene but declined to preliminarily stay the 2023 REMS. Instead, the court stayed the case to allow the FDA to complete its review of the mifepristone REMS. However, the Fifth Circuit granted a stay of the 2023 REMS pending appeal, finding that Louisiana had standing and was likely to succeed on the merits. Danco and GenBioPro separately filed applications for stay before the Supreme Court.

In its response, Louisiana opposed a stay of the Fifth Circuit’s decision but said that if the “Court nonetheless were inclined to grant a stay, Plaintiffs would acquiesce in certiorari before judgment and oral argument before the summer recess.” While the FDA notably did not submit a brief, former FDA commissioners filed an amicus brief highlighting how the FDA’s “close examination of mifepristone’s safety profile” was “consistent with sound science.” Two sets of states also filed amicus briefs, one set supporting the Fifth Circuit’s stay and the other opposing it.

The FDA’s decisions pertaining to mifepristone were also before the Supreme Court in 2024. The Fifth Circuit had affirmed the Northern District of Texas’s decision to stay the 2016 REMS amendments and the FDA’s 2021 non-enforcement decision to allow access by mail. However, the Supreme Court ultimately concluded that the plaintiff doctors and associations lacked standing to challenge these actions.

The case is Nos. 25A1207 and 25A1208.

Judge: Alito, S.

Attorneys: John Patrick Elwood (Arnold & Porter Kaye Scholer LLP) for GenBioPro, Inc. Jessica Lynn Ellsworth (Hogan Lovells US, LLP) for Danco Laboratories, L.L.C. Jorge Benjamin Aguinaga, Louisiana Department of Justice, for The State of Louisiana.

Companies: Danco Laboratories, L.L.C.; GenBioPro, Inc.

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