Drug Makers Seek Supreme Court Review of Abortion Pill Mail-Order Block

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.

General Liz Murrill stated that the ruling protects women and babies by countering the FDA's policy. Marjorie Dannenfelser, head of Susan B. Anthony Pro-Life America, described it as a victory against a reckless mail-order regime. The decision creates a circuit split, as the Ninth Circuit has taken a different stance on standing in related cases.

Mifepristone, used with misoprostol, blocks progesterone to terminate pregnancies and is also prescribed for miscarriages and Cushing syndrome. The drug has been used by more than 6 million patients in the U.S., according to Danco. Studies cited in the sources contest claims of its safety, noting adverse effects on some women.

This case follows a 2024 Supreme Court ruling in FDA v. Alliance for Hippocratic Medicine, where the court unanimously dismissed a challenge due to lack of standing. The panel, consisting of judges appointed by former President George W. Bush and President Donald Trump, noted the regulation enables out-of-state prescribers to defy Louisiana law.

Critics argue the standing claims are speculative and could broaden state challenges to federal regulations. The Supreme Court's potential intervention could address the nationwide impact, including a split with the Ninth Circuit on standing. A lower court had paused the case earlier this month pending an FDA review under the Trump administration.

The Fifth Circuit's stay overrides that pause.

“The resulting chaos for patients, providers, pharmacies, and the drug-regulatory system is a quintessential irreparable harm that underscores the need for emergency relief from this Court.”

The ruling curbs access in states with abortion bans, where medication abortion is the most common method. The case originated in Louisiana, with appellate jurisdiction over Mississippi and Texas.