May 15, 2026 - By Laurie Sobel - On Thursday, May 14th, the U.S. Supreme Court blocked a lower court order in Louisiana v. FDA that would have restricted the nationwide distribution of mifepristone. The Court’s action leaves current FDA rules in place, allowing mifepristone-part of a two-drug regimen used in medication abortion – to be prescribed via telehealth and dispensed by mail or at retail pharmacies while the litigation continues pending a final decision by the Supreme Court. Justice Alito and Thomas dissented from the Court’s decision. The case now returns to the 5th Circuit Court of Appeals for further consideration.
The Court’s order responds to a ruling by the U.S. Court of Appeals for the Fifth Circuit, which ordered reinstatement of earlier restrictions requiring in-person dispensing. In Louisiana v FDA, Louisiana argues that the FDA’s 2023 Risk Evaluation and Mitigation Strategy (REMS) changes exceeded the agency’s authority and violated the 1873 Comstock Act, which they contend prohibits mailing abortion medications.
The case stems from a 2025 lawsuit brought by Louisiana alleging the FDA violated the Administrative Procedure Act in updating mifepristone’s REMS. Those updates removed the in-person dispensing requirement, expanding access through telehealth and pharmacy distribution. Louisiana argues these changes undermine its ability to enforce its abortion ban and has caused financial harm by increasing state spending on emergency care for patients who obtained mifepristone by mail. It’s not clear whether the Supreme Court agrees with the lower courts that Louisiana has standing to bring this case. In 2024 in a similar case, the Supreme Court ruled in Alliance for Hippocratic Medicine v. FDA, that a group of doctors, associations and organizations that oppose abortion lacked legal standing to challenge the FDA’s approval of mifepristone but did not reach the merits of their claims.
Earlier this year, a federal district court paused the case to allow the FDA to conduct an internal safety review of mifepristone and its updated dispensing rules. After Louisiana appealed that decision, the Fifth Circuit ordered a rollback of those rules pending appeal, prompting emergency appeals from manufacturers, Danco Laboratories and GenBioPro. Notably, while the Trump administration defended the FDA’s authority in lower courts, it did not file briefs before the Supreme Court in this case. After a temporary administrative stay by Justice Samuel Alito, the full Court has now blocked the Fifth Circuit’s order and returned the case for further proceedings.
In addition to ongoing litigation, last September the Trump administration FDA, after requests from anti-abortion organizations and state attorneys general, initiated an internal review of mifepristone’s safety. This adds uncertainty as the agency could revise dispensing rules independently of the courts. With the FDA commissioner’s resignation this week and no permanent leader in place, the timeline for completing the review remains unclear.
Mifepristone was first approved by the FDA more than 25 years ago with in-person dispensing requirements. In 2023, after extensive evidence repeatedly affirmed the drug’s safety, the FDA removed the in-person dispensing requirement, allowing prescribing via telehealth and dispensing by mail or through retail pharmacies. In the wake of the Dobbs decision overturning the federal right to abortion, this option provides access to medication abortion, particularly for patients in states where the provision of abortion is heavily restricted, as well as for those residing in rural areas in states where services remain legal but where there are few providers. Telehealth abortions have been increasing as a share of all abortions – 27% in the first half of 2025. Mailing mifepristone enabled clinicians to provide abortion medication to tens of thousands patients across state lines, supported by state shield laws protecting providers from out-of-state prosecution.
Source: KFF
