UPDATE: Shortly after this alert was revealed, the Supreme Courtroom granted an administrative keep of the Fifth Circuit’s order. Because of this, whereas the Supreme Courtroom opinions Danco’s and GenBioPro’s emergency requests that the Fifth Circuit’s keep be vacated, mifepristone is accessible below the 2023 REMS, which allows allotting of mifepristone on to sufferers by sure pharmacies, together with by sure mail-order pharmacies. We’ll proceed to observe this litigation and can present additional updates as they’re out there.
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On Could 1, 2026, the Fifth Circuit Courtroom of Appeals (the “Fifth Circuit”) issued an opinion within the ongoing litigation relating to the U.S. Meals & Drug Administration’s (“FDA”) regulation of mifepristone, a drug authorized to be used in medically induced abortions and routinely used “off-label” to deal with early miscarriages. Ruling in favor of the State of Louisiana, the Fifth Circuit issued a keep of 2023 laws by the FDA, which permitted mifepristone to be distributed by sure pharmacies, together with sure mail-order pharmacies. Defendant drug producers Danco and GenBioPro have every submitted emergency purposes to the Supreme Courtroom of america (the “Supreme Courtroom”) requesting that the Fifth Circuit’s keep be vacated and that the order be administratively stayed whereas the Supreme Courtroom considers the emergency purposes.
Background
In 2000, the FDA authorized mifepristone for the medical termination of being pregnant topic to plenty of restrictions, together with, amongst others, that: (i) mifepristone might be used for termination of being pregnant solely by seven weeks’ gestation; (ii) solely physicians might prescribe mifepristone; and (iii) allotting and administration of mifepristone and of a associated drug, misoprostol, and a follow-up appointment, should every happen at separate, in-person physician’s-office visits. These restrictions have been later included within the first Danger Analysis and Mitigation Technique (“REMS”) for mifepristone, which was authorized by the FDA in 2011.
In 2016, the FDA amended the mifepristone REMS by: (i) allowing use of mifepristone for termination of being pregnant by ten weeks’ gestation; (ii) permitting non-physician prescribers to prescribe mifepristone; and (iii) eradicating the necessities that misoprostol administration and the follow-up go to happen in individual (the “2016 REMS”). In 2019, the FDA authorized a generic model of mifepristone.
Extra not too long ago, in 2021, the FDA introduced that, because of the COVID-19 pandemic, it could not implement the in-person allotting requirement for mifepristone. The FDA formalized this variation with an up to date mifepristone REMS in January 2023, which additionally expanded entry to mifepristone by permitting sure pharmacies, together with giant chains and mail-order corporations, to dispense mifepristone on to sufferers with a prescription from an authorized supplier (the “2023 REMS”).
Standing of Litigation
As these following this litigation will recall, in 2024, in separate however associated litigation, the Supreme Courtroom rejected a problem to the 2016 REMS and 2023 REMS, overturning a keep (which by no means went into impact) imposed by the Fifth Circuit. A earlier alert on that call is accessible right here. Importantly, the Supreme Courtroom’s 2024 determination was primarily based on the plaintiff states’ lack of standing and didn’t tackle the deserves of the problem.
This new lawsuit was filed in 2025 by the State of Louisiana, which argues that it has standing as a result of the 2023 REMS permits for “streams of mifepristone by mail into Louisiana for the specific function of inflicting 1000’s of abortions in Louisiana yearly,” in violation of Louisiana’s basic ban on abortion.
In April 2026, a federal District Courtroom in Louisiana granted a keep of litigation whereas the FDA completes an ongoing evaluation of the mifepristone regulation, which started in September 2025. The State of Louisiana appealed to the Fifth Circuit, which granted a keep of the 2023 REMS, that means that pharmacies, together with giant chain and mail-order corporations, could now not dispense mifepristone on to sufferers with a prescription from an authorized supplier.
Intervenor-defendant pharmaceutical corporations Danco and GenBioPro, which manufacture mifepristone, have submitted emergency purposes to the Supreme Courtroom requesting that the keep be vacated and that the order be administratively stayed because the Supreme Courtroom considers the emergency purposes.
Wanting Forward and Sensible Takeaways
In the meanwhile, and except the Supreme Courtroom intervenes, the 2023 REMS are stayed, that means that mifepristone will not be distributed on to sufferers by pharmacies – together with, however not restricted to, mail order pharmacies. In different phrases, at current, mifepristone could also be distributed to sufferers solely in sure well being care settings, by or below the supervision of an authorized prescriber.
Well being care suppliers and pharmacies ought to proceed to carefully monitor ongoing developments, together with motion by the Supreme Courtroom and state regulation actions associated to the prescribing of mifepristone, and will additional evaluation present insurance policies and procedures associated to the prescribing and allotting of mifepristone to make sure consistency with the keep and state regulation.
Corridor Render is actively monitoring the continued litigation and regulatory exercise associated to mifepristone in addition to associated state regulation points. You probably have questions relating to mifepristone or want help in reviewing and updating practices associated to mifepristone use, please contact:
Corridor Render weblog posts and articles are supposed for informational functions solely. For moral causes, Corridor Render attorneys can not—outdoors of an attorney-client relationship—reply particular questions that may be authorized recommendation.