Pharmaceutical manufacturer Danco Laboratories filed an application with the U.S. Supreme Court on Saturday requesting a stay of a recent appeals court order that temporarily prevents mifepristone from being dispensed through the mail. The appeals court action, handed down unanimously by a three-judge conservative panel on Friday, curtails nationwide mail-order access to the drug and is especially consequential in states where abortion has been banned.
The case originated with a lawsuit brought by the Republican-led state of Louisiana. The state argued the U.S. Food and Drug Administration disregarded the potential for serious adverse events, including sepsis and hemorrhaging, when it adopted a 2023 regulation allowing mifepristone to be mailed rather than requiring in-person dispensing. The appeals panel concluded Louisiana was likely to prevail in its legal challenge and issued a temporary ruling accordingly.
In its filing to the Supreme Court, Danco said the appeals court decision "injects immediate confusion and upheaval into highly time-sensitive medical decisions - and it forces Danco, FDA, certified Mifeprex providers, patients, and pharmacies all to guess at what is allowed and what is not." The company has emphasized the operational and clinical uncertainty the order creates while asking the high court to halt the appeals ruling while the litigation proceeds.
This temporary appellate decision is the first to substantially restrict access to mifepristone in a sequence of lawsuits that contest the drug’s initial approval in 2000 and subsequent rule changes intended to widen access. The 2023 FDA regulation removed the requirement that mifepristone be dispensed only in person, permitting certified providers to prescribe and pharmacies to ship the drug to patients.
Research cited from the University of Southern California was referenced in the litigation record showing that in states where abortion is legal and telehealth prescribing is permitted, fewer than 2% of abortion drug prescriptions are filled in person. That statistic was used to illustrate how the 2023 rule had already shifted most dispensing away from in-person pick-up toward remote fulfillment.
Both GenBioPro and Danco Laboratories have intervened in Louisiana’s lawsuit to defend the FDA regulation. Danco’s brand-name version of mifepristone, Mifeprex, is noted as the company’s sole product.
The matter has drawn multiple parallel legal challenges. In 2024 the Supreme Court considered a separate challenge to the mail-order rule brought by medical groups and individual doctors, but the justices held those plaintiffs lacked legal standing to pursue their claims. That case was later taken over by the states of Missouri, Kansas and Idaho and remains pending.
Earlier developments in the lower courts are also relevant to the current posture. U.S. District Judge David Joseph issued a decision on April 7 that paused Louisiana’s lawsuit pending a safety review of mifepristone by the executive branch. Media reporting referenced in court filings indicates that review by the administration of President Donald Trump has been delayed until after the November midterm elections. In his April ruling Judge Joseph denied Louisiana’s request to block the 2023 rule immediately but agreed with the state that the rule was likely unlawful, signaling he expected to rule in Louisiana’s favor when the case resumes.
Summary
Danco Laboratories has asked the U.S. Supreme Court to stay an appeals court order that temporarily prevents mifepristone from being dispensed through the mail. The appeals ruling, issued unanimously by a conservative three-judge panel, found Louisiana likely to succeed in arguing the FDA unlawfully adopted a 2023 rule permitting mail-order dispensing. Danco and GenBioPro have intervened in the case to defend the FDA regulation. Related legal challenges remain pending, including a separate case taken over by Missouri, Kansas and Idaho after the Supreme Court found earlier plaintiffs lacked standing. A district court earlier paused Louisiana’s suit pending an executive-branch safety review that has been reported to be delayed until after the November midterm elections.
Key points
- The appeals court’s temporary order blocks mail-order dispensing of mifepristone and narrows access nationwide, particularly in states that ban abortion - impacting pharmaceutical manufacturers and pharmacies.
- Danco and GenBioPro have intervened in defense of the FDA’s 2023 regulation that eliminated the in-person dispensing requirement - a regulatory and legal battleground for the pharmaceutical and telehealth sectors.
- Ongoing litigation includes a separate Supreme Court matter now pursued by Missouri, Kansas and Idaho, and a district court action paused pending an executive safety review that has been reported to be delayed.
Risks and uncertainties
- Supreme Court disposition - The high court’s decision on Danco’s stay application or on other pending matters could alter nationwide access to mail-ordered mifepristone, creating regulatory and market uncertainty in the pharmaceutical and pharmacy sectors.
- Pending executive safety review timing - The district court paused proceedings pending a safety review reported to be delayed until after the November midterm elections, prolonging legal uncertainty and operational disruption for makers and dispensers of the drug.
- Multiple overlapping lawsuits - Parallel challenges at different judicial levels, including the case taken over by Missouri, Kansas and Idaho, create an uncertain legal landscape for manufacturers, telehealth providers, and pharmacies that rely on the 2023 FDA rule.