Health Law Daily Wrap Up, DRUGS AND BIOLOGICS—U.S.: Supreme Court maintains status quo on mifepristone access pending appeal, (May 15, 2026)

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

Justices Thomas and Alito dissented.

The U.S. Supreme Court has preserved mail access to mifepristone pending appeal. The Court’s order pauses a May 1 decision by the Fifth Circuit that stayed the FDA’s 2023 removal of the in-person dispensing requirement from mifepristone’s Risk Evaluation and Mitigation Strategy (REMS) pending appeal. Justices Thomas and Alito dissented, with Alito calling the order “unreasoned” because it undermines the Court’s decision in Dobbs v. Jackson Women’s Health Organization, 597 U. S. 215 (2022). This case will surely end up back before the Court in the future (Danco Laboratories, LLC v. Louisiana, No. 25A1207 (U.S. May 14, 2026); GenBioPro, Inc. v. Louisiana, No. 25A1208 (May 14, 2026)).

In October, Louisiana and a private plaintiff filed a lawsuit challenging under the Administrative Procedure Act the FDA’s 2023 removal of the in-person dispensing requirement. After the district court stayed the case to allow the FDA to complete its review of the mifepristone REMS, the Fifth Circuit granted a stay of the 2023 REMS pending appeal. Mifepristone manufacturers Danco Laboratories and GenBioPro, Inc. each filed applications for stay before the Supreme Court, and the Court administratively stayed the Fifth Circuit’s decision through May 14.

Justice Alito, dissenting from the Court’s May 14 order, argued, “What is at stake is the perpetration of a scheme to undermine our decision in Dobbs…, which restored the right of each State to decide how to regulate abortions within its borders.” Some states, like Louisiana, chose to make abortion illegal, but “Louisiana’s efforts have been thwarted by certain medical providers, private organizations, and States that abhor laws like Louisiana’s and seek to undermine their enforcement.” He also pointed out that shield laws have hindered the state’s ability to sue or prosecute those that mail the medication from other states. This “scheme,” he argued, would not have been possible without the FDA’s 2021 and 2023 removal of the in-person dispensing requirement.

In his brief dissent, Justice Thomas argued that the mailing of mifepristone, as permitted by the 2023 REMS, violates the Comstock Act (18 U.S.C. §§ 1461, 1462). The manufacturers, therefore, “are not entitled to a stay of an adverse court order based on lost profits from their criminal enterprise.”

The case is No. 25A1207 and No. 25A1208.

Judge: Alito, S.

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

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

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