Appeals Court Pauses FDA Mail-Order Mifepristone Permissions in Louisiana Case

The U.S. Court of Appeals for the 5th Circuit unanimously granted Louisiana's request for a stay that pauses the Food and Drug Administration's permissions for mail-order distribution of mifepristone. The ruling addresses claims in a lawsuit filed by the state and plaintiff Rosalie Markezich.

Danco Laboratories, the manufacturer of mifepristone, argued that its financial interests in continued sales should factor into the decision. The court stated that Danco’s potential financial losses pale beside Louisiana’s sovereign interest in its laws protecting the unborn and the public’s interest in not exposing women to unsafe medical procedures.

The 5th Circuit found that Louisiana showed irreparable harm through daily costs to Medicaid for emergency care and through the undermining of state laws. The panel noted that those costs are ongoing and sufficient to meet the irreparable harm standard.

The U.S. Supreme Court temporarily halted the 5th Circuit’s block for two days to allow both parties to brief the court. The underlying case remains ongoing.

Mifepristone is used in chemical abortions, the most common method of ending pregnancy in the U.S. Reported side effects include bleeding, dizziness, headache, vomiting, and severe complications such as hemorrhage or infection. One analysis of insurance data indicated that more than one in 10 women experience a serious adverse event after taking mifepristone.

Louisiana presented evidence that the risk of life-threatening effects is at least 22 times higher than FDA and manufacturer claims when used beyond the recommended 10 weeks. The state also documented financial burdens from taxpayer-funded treatment of women who required emergency care after unsupervised use.

Danco Laboratories stated that it is required to report complications to the FDA.

Additional Developments Sen.

Josh Hawley introduced legislation to ban mifepristone and provide remedies for survivors. Bill Cassidy, Steve Daines, Lindsey Graham, Cindy Hyde-Smith, and James Lankford sent a letter to Danco Laboratories expressing concerns about compliance with safety requirements for online prescribing.

U.S. Health and Human Services Secretary Robert F. Kennedy Jr. and Commissioner of Food and Drugs Marty Makary pledged in 2025 to review safety data on the drug. A Wall Street Journal report this week stated that Makary indicated a study cannot be completed until a new data-monitoring system is operational.

Polling shows a majority of likely voters want the FDA to protect women from risks associated with the drug, and seven in 10 favor reinstating in-person doctor visits as a requirement.