US Supreme Court Restores Access to Mifepristone — For Now*

When it first approved mifepristone in 2000 under the brand name Mifeprex, the US Food and Drug Administration (FDA) imposed restrictions on the drug’s distribution under 21 C.F.R. § 314.520. Years later, the FDA Amendments Act of 2007 (FDAAA) established the Agency’s authority to require Risk Evaluation and Mitigation Strategies (REMS), a drug safety program aimed at ensuring that the benefits of a medication with “serious safety concerns” outweigh the risks. Following passage of the FDAAA, the FDA approved a REMS for mifepristone in 2011. 

The requirement of a REMS for mifepristone is itself controversial, and the FDA has gradually eased the mifepristone REMS restrictions over the last decade — most recently modifying the REMS in January 2023 to permanently remove the prior in-person dispensing requirement and adding pharmacy certification, thereby enabling dispensing by certified pharmacies and mail delivery when prescribed by certified prescribers.

In October 2025, Louisiana filed a lawsuit challenging the January 2023 REMS modification, alleging violations of the Administrative Procedure Act, and claiming that the 2023 REMS impedes the state’s ability to regulate abortion within its borders, and seeking a stay of the modification while its case proceeded. The district court denied the stay in April 2026, opting instead to delay further proceedings pending the FDA’s ongoing safety review of mifepristone, which was expected to conclude later in 2026. Louisiana appealed. On May 1, a Fifth Circuit panel granted the stay, temporarily reimposing the in-person dispensing requirements on mifepristone and thereby prohibiting the use of telemedicine and mail distribution nationwide, absent further relief. Notably, the Fifth Circuit gave credence to Louisiana’s contention that mail availability enables residents to obtain mifepristone despite the state’s restrictions on medical abortions, concluding that Louisiana had shown that it would be irreparably harmed without a stay.

On May 4, following emergency applications filed by Danco Laboratories and GenBioPro, the pharmaceutical companies that manufacture mifepristone, the Supreme Court issued administrative stays temporarily blocking the Fifth Circuit order until May 11, which the Supreme Court further extended until May 14. Under the Supreme Court administrative stays, mifepristone currently remains available via telemedicine and mail distribution.

Importantly, neither the Fifth Circuit order nor the Supreme Court administrative stays change the requirements for the prescribing of misoprostol. Health care providers have indicated that, if mifepristone access is restricted or banned due to this litigation, they may pivot to prescribing misoprostol‑only regimens for medication abortions.

If the Fifth Circuit order ultimately stands and is not overturned on further review, the interstate telemedicine prescribing and mailing of mifepristone would be significantly undermined, even for providers operating from states that protect abortion access. Additionally, patients — including those in states where abortion remains legal — could face new logistical obstacles, including requirements to obtain mifepristone in-person at clinics or hospitals.

Given the multiple active challenges to mifepristone’s approval and accompanying REMS by other states including Missouri and Texas, the intersection of state abortion bans with federal drug oversight, and the Supreme Court’s ongoing involvement, health care providers, pharmacies, and telemedicine platforms should closely watch this space.

The district court case is Louisiana v. FDA, No. 6:25-cv-01491 (W.D. La.) and the Fifth Circuit Court of Appeals case is Louisiana v. FDA, No. 26-30203 (5th Cir.). At the Supreme Court level, the emergency applications are docketed as Danco Laboratories, LLC v. Louisiana, No. 25A1207 (2026) and GenBioPro, Inc. v. Louisiana, No. 25A1208 (2026).

ArentFox Schiff will continue monitoring the dockets for these matters and providing substantive updates as they come. If you are interested in more information about the mifepristone approval, REMS, mailing of mifepristone or misoprostol, or any related issue, please contact ArentFox Schiff’s Reproductive Health Task Force.

* Shortly after our analysis was published, the US Supreme Court granted the emergency applications and has now stayed the Fifth Circuit Court of Appeals May 1 order pending disposition of the appeal.