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5d ago

Texas and Florida Sue FDA to Overturn Mifepristone Approvals and Mail-Order Access

The Wichita Falls case contests FDA decisions on mifepristone as unlawful agency action.

Martin Makary, the commissioner of the FDA, during an interview in Washington, D.C., on July 18, 2025.
Boxes of the drug mifepristone sit on a shelf at the West Alabama Women’s Center in Tuscaloosa, Ala., on March 16, 2022. On Tuesday, March 26, 2024, the U.S. Supreme Court will take up a case that could impact how women get access to mifepristone, one of the two pills used in the most common type of abortion in the nation. (AP Photo/Allen G. Breed, File)
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Overview

  • Republican attorneys general Ken Paxton of Texas and James Uthmeier of Florida filed the lawsuit in federal court in Wichita Falls, seeking to void FDA decisions dating to 2000.
  • The complaint targets the original approval of mifepristone and the Sept. 30, 2025 authorization of Evita Solutions’ generic, along with later policies enabling telehealth prescribing, mail dispensing, non-physician dispensing and extended gestational limits.
  • The states allege the FDA acted arbitrarily in violation of the Administrative Procedure Act, argue mail shipment violates the Comstock Act and claim federal policies undermine their abortion restrictions.
  • The case will be assigned to a judge before an initial hearing, joining related state-led challenges in Missouri and Louisiana after the Supreme Court last year found earlier private plaintiffs lacked standing.
  • Mifepristone is used in a majority of U.S. abortions and decades of studies find it safe and effective, as telehealth provision has grown to about 27% of abortions in early 2025; advocacy groups say the suits aim to restrict access rather than address safety.