Texas judge pauses mifepristone lawsuit until after midterm elections; FDA allowed to finish safety review

A federal judge in Texas paused a lawsuit brought by the attorneys general of Florida and Texas that seeks to revoke the U.S. Food and Drug Administration's approval and subsequent access policies for the abortion drug mifepristone. The pause runs until at least Dec. 1, and the FDA's request for a stay was granted so it can finish an independent safety review of the medication.

The stay prevents immediate court action that could alter nationwide access to mifepristone while the FDA completes a safety review it began in June. The agency estimated that review would take about six months. The pause effectively delays any final judicial decision until after the 2026 midterm elections.

Florida and Texas filed the suit in December seeking to permanently revoke the FDA's initial 2000 approval of mifepristone and later policy changes that expanded access. The complaint cites, in part, the Comstock Act, a 150-year-old federal anti-obscenity law that historically prohibited mailing materials that could induce abortion. That statute has not been enforced for many decades but is invoked in the plaintiffs' legal theory.

Defendants and procedural developments

Danco Laboratories and GenBioPro, manufacturers/distributors of mifepristone, intervened as defendants in April. U.S. Chief District Judge Reed O'Connor denied their motion to dismiss, keeping the manufacturers in the case and allowing litigation to proceed after the stay expires.

This suit is among multiple ongoing legal challenges over mifepristone: the 5th U.S. Circuit Court of Appeals is scheduled to hear oral arguments on Sept. 9 in a separate Louisiana case that targets rules allowing the medication to be dispensed without an in-person visit. Attorneys general in Missouri, Idaho, and Kansas have also asked a federal judge in Missouri to roll back post-2016 dispensing changes, including in-person visit waivers and gestational limits.

GenBioPro's CEO Evan Masingill said the company expects the FDA's review "to not contradict the decision they made in 2023 that reaffirmed our product is safe and effective," and that GenBioPro would continue to use legal and regulatory tools to preserve access to reproductive care.

The court's decision to pause the case pushes any substantive ruling past the midterm elections and gives the FDA time to complete its review. The outcome of these coordinated lawsuits could change nationwide access to medication abortion and related telehealth dispensing rules depending on how courts rule across the different cases.