Supreme Court to Act by End of Day on Mifepristone Restrictions Case

The Supreme Court is expected to take further action by the end of the day on May 11 in a case challenging FDA actions on mifepristone. A temporary administrative stay issued by Justice Samuel Alito has paused a Fifth Circuit ruling that would reinstate requirements for in-person dispensing of the drug.

That stay expires today unless the court extends it or issues a longer-term decision. The Fifth Circuit ruling addressed whether the FDA followed proper procedures under the Administrative Procedure Act when it changed the rules.

Louisiana argues the FDA's decision lacked sufficient scientific backing and violates the Comstock Act, an 1873 law restricting the mailing of abortion-related materials. The state also says it has standing to sue because it bears costs related to any medical complications.

California-based suppliers have already prepared backup plans to continue providing medication abortions if the restrictions take effect. Providers told the Los Angeles Times their supply chains are ready to switch within a day to a misoprostol-only regimen.

One co-founder of a network that mails pills said organizations began shipping the alternative drug immediately after learning of the potential change.

Mifepristone is currently used in nearly two-thirds of all U.S. abortions. After the 2022 Dobbs decision, the total number of abortions in the country slightly increased, driven largely by greater availability of the two-drug regimen through telehealth and mail-order pharmacies. The FDA removed the in-person dispensing requirement for mifepristone in 2023.

The case centers on whether states can impose stricter limits than those set by the FDA. Nine former FDA commissioners submitted an amicus brief arguing the agency had been extremely cautious in its decision and that overturning it would undermine the FDA's science-based drug approval system.

The pharmaceutical industry's main lobbying group warned that allowing the lower court ruling to stand could reduce incentives for companies to develop new drugs by creating uncertainty around regulatory decisions. More than two dozen food and drug law scholars filed briefs stating the Fifth Circuit's decision rested on critical misunderstandings of federal food and drug law and the evidence used by the FDA.

The briefs emphasized that voluntary adverse event reporting is the standard for nearly all approved drugs.

If the Supreme Court allows the in-person requirement to return, providers could still offer virtual consultations and mail misoprostol alone, which was originally approved for gastric ulcers but is also used for abortions. Health officials have noted that the misoprostol-only approach is less effective than the two-drug combination and carries a higher risk of side effects, according to the World Health Organization.

Enforcement of any new restrictions would fall to the FDA, which oversees drug manufacturers that in turn certify providers. Experts said a new Risk Evaluation and Mitigation Strategy would need to be created, and existing supplies labeled under the 2023 policy would require time before full enforcement.

The FDA and current administration have not submitted defenses in this round of the case. Other ongoing mifepristone cases have been paused pending an FDA safety review expected in the fall. That review was announced as informed by concerns over prior approvals.

"The fundamental question is: Who gets to regulate mifepristone? Can a state go further than the FDA? " — Laurie Sobel, associate director for women’s health policy at KFF, May 8, 2026 (STAT News). The Supreme Court could issue a quick decision on the shadow docket, send the case back to the Fifth Circuit, or address the merits directly.

A ruling based on the Comstock Act would more narrowly target abortion medications and could be addressed by congressional action amending the law.

The decision has prompted renewed calls for updates to the Voting Rights Act that would explicitly outlaw gerrymandering. Tennessee lawmakers recently redrew congressional maps in a way that divided the state's only majority-Black district centered on Memphis into three Republican-leaning seats.

The changes also weakened voter notice requirements. Louisiana officials moved quickly to redraw congressional maps after the Supreme Court found a prior version unconstitutional. The state's governor suspended primaries during the process.