A federal appeals court on Friday suspended a Biden-era regulation that allowed the abortion drug mifepristone to be prescribed online and dispensed through the mail. The ruling immediately halts telemedicine abortion pill prescriptions nationwide while litigation continues.
The unanimous three-judge panel of the US Court of Appeals for the Fifth Circuit stayed the Food and Drug Administration’s 2023 Risk Evaluation and Mitigation Strategy (REMS), siding with Louisiana in a challenge that stems from the Supreme Court’s 2022 Dobbs decision returning abortion regulation to the states.
Mifepristone now accounts for more than 60 percent of abortions in the United States, making the ruling’s nationwide reach significant for abortion access even in states where the procedure remains legal.
The court found Louisiana was likely to succeed in its argument that the FDA acted arbitrarily and capriciously when it removed mifepristone’s in-person dispensing requirement, citing the agency’s own concession that its review was marred by “procedural deficits” and a “lack of adequate consideration.”
Central to the court’s reasoning was a procedural circularity: the FDA had previously eliminated the requirement that mifepristone’s adverse events be reported to its safety database, then cited the resulting absence of reports as evidence the drug was safe to dispense remotely.
When mifepristone was first approved in 2000, patients were eligible only after three in-person visits to a physician. The 2023 regulation formalized a pandemic-era policy allowing the drug to be prescribed remotely and sent through the mail.
Louisiana filed its challenge under the Administrative Procedure Act in October 2025, arguing the FDA’s justifications relied on flawed or absent data. The state documented nearly 1,000 of what it described as illegal abortions per month facilitated by the regulation and roughly $92,000 in Medicaid costs tied to emergency care for two women who suffered complications from out-of-state mifepristone.
The FDA acknowledged in court that it had failed to adequately study whether remote prescribing is safe and launched a comprehensive review in September 2025. The court noted the agency had offered no completion date and was still collecting data.
Similar challenges to the 2023 REMS are pending in other federal courts. The Fifth Circuit acknowledged the risk of conflicting rulings but said that did not excuse it from deciding the case.
