The maker of the leading brand of mifepristone has turned to the US Supreme Court in an urgent bid to overturn a ruling that has temporarily blocked mail-order access to the abortion pill.
Danco Laboratories lodged its application on Saturday, asking the justices to stay a decision handed down a day earlier by a conservative three-judge panel of a federal appeals court. According to Reuters, the unanimous ruling significantly curtails access to the drug nationwide, with the sharpest consequences expected to fall on states that have already outlawed abortion.
In its filing, the company painted a picture of an industry thrown into disarray. The decision, Danco told the court, “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.” Mifeprex, the brand-name form of mifepristone, is the company’s only product.
At the heart of the dispute is a lawsuit brought by Republican-led Louisiana, which argues that the US Food and Drug Administration brushed aside the risk of serious adverse events — including sepsis and haemorrhaging — when it adopted a 2023 rule permitting mifepristone to be dispensed by post. The appeals court panel concluded that Louisiana was likely to succeed in that argument.
Though temporary, the ruling carries weight. It is the first to land any real restriction on mifepristone in the face of a procession of legal challenges aimed at unwinding the drug’s original approval in 2000 and the subsequent regulations that have steadily widened access. The 2023 rule, which scrapped the requirement that the pill be handed to patients in person, has fundamentally rewired the way it reaches them. Research from the University of Southern California, cited by Reuters, found that in states where abortion remains legal and telehealth prescribing is allowed, fewer than 2 per cent of abortion drug prescriptions are now filled in person.
Danco is not fighting alone. Fellow manufacturer GenBioPro has also intervened in the Louisiana case to defend the FDA regulation. The Supreme Court itself considered a separate challenge to the mail-order rule in 2024, brought by medical groups and doctors, but threw it out on the grounds that the plaintiffs lacked the legal standing to sue. That case has since been picked up by Missouri, Kansas and Idaho, and remains live.
The procedural backdrop has grown more tangled still. On 7 April, US District Judge David Joseph paused Louisiana’s lawsuit while President Donald Trump’s administration conducted a review of the safety of mifepristone — a review that, according to media reports, has been pushed back until after November’s midterm elections. Judge Joseph stopped short of granting Louisiana’s request to block the 2023 rule outright, but made plain that he agreed the regulation was probably unlawful, telegraphing how he is likely to come down once the case is back before him.
