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Drug Makers Ask Supreme Court to Review Abortion Pill Mail-Order Ruling
Pharmaceutical companies producing mifepristone have petitioned the U.S. Supreme Court to pause a federal appeals court ruling that temporarily blocks the drug's distribution by mail. The Fifth Circuit's Friday decision reinstated an in-person requirement for obtaining the abortion pill, stemming from a lawsuit by Louisiana.
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The U.S. Court of Appeals for the Fifth Circuit issued a ruling on Friday that temporarily blocks a Food and Drug Administration regulation allowing mifepristone to be prescribed via telemedicine and distributed by mail. The unanimous panel concluded that Louisiana is likely to prevail in its challenge, citing the regulation's impact on state abortion laws and potential medical complications.
The decision applies nationwide and remains in effect as the case proceeds. Danco Laboratories, which produces the brand-name version of mifepristone, and GenBioPro, the generic manufacturer, filed emergency applications with the Supreme Court on Saturday seeking to stay the appeals court's order.
They argued that the ruling causes irreparable harm to patients, providers, and the drug distribution system. The FDA has not yet filed a response to the Supreme Court.
Background on the Regulation The FDA first approved mifepristone in 2000 for terminating pregnancies up to seven weeks, later extending it to 10 weeks in 2016. Initially, the drug required in-person dispensing. In 2021, amid the COVID-19 pandemic, the FDA temporarily allowed mail-order access, making it permanent in 2023.
Louisiana's lawsuit claims the 2023 regulation facilitates circumvention of state abortion bans, creating sovereign and financial injuries. The state cited two cases where women experienced complications from mifepristone obtained out-of-state, with costs borne by Louisiana.
The Fifth Circuit found these arguments sufficient for standing, contrasting with a prior Supreme Court dismissal of a similar challenge in 2024 for lack of standing. The appeals court referenced a specific incident involving Rosalie Markezitch, who alleged coercion into using mail-order mifepristone from California.
Louisiana argues that in-person requirements would have prevented such outcomes. Abortion is illegal in Louisiana except for limited maternal health exceptions, and the state classified mifepristone as a controlled substance in 2024.
