States Renew Assault on FDA Approval, Challenge Access to Mifepristone

Texas and Florida launched a new legal assault on federal regulation of the abortion pill mifepristone on December 10, filing suit in a Wichita Falls, Texas federal court that seeks to curtail access to the drug after the U.S. Food and Drug Administration approved a new generic version this fall. The Republican attorneys general contend the agency has not adequately reexamined the drug since its initial approval in 2000 and that the FDA’s more recent actions were arbitrary and capricious in violation of the Administrative Procedure Act.

The complaint challenges both the original 2000 approval of mifepristone and the FDA’s September approval of a generic produced by Evita Solutions. The case is styled Florida v. U.S. Food and Drug Administration, filed in the U.S. District Court for the Northern District of Texas, and listed under case number 7:25 cv 00126. Plaintiffs seek judicial relief that could limit the agency’s regulatory authority over mifepristone and potentially constrain the availability of medication abortion in states across the country.

The filing echoes earlier litigation brought by Missouri, Kansas and Idaho, which produced a high profile earlier sweep through the federal courts. In 2024 the U.S. Supreme Court declined to unwind FDA regulation of mifepristone on standing grounds, leaving in place key regulatory decisions but not ending the separate state led challenges now advancing in lower courts. Legal experts say the new suit raises some of the same questions about judicial review of long standing agency determinations while testing procedural claims under the Administrative Procedure Act.

Mifepristone is typically used in combination with misoprostol for medication abortions and is now involved in more than 60 percent of abortions in the United States. As such, disruptions to its availability or changes to FDA labeling and distribution requirements could affect clinics, pharmacies and providers who rely on the drug, as well as patients seeking remote care or prescriptions by mail in states where that is permitted.

The FDA did not immediately respond to requests for comment. Evita Solutions said it believes all people should have access to safe, affordable, high quality reproductive healthcare. The company has been engaged in the regulatory process as it sought approval to market a lower cost generic version, an approval the states now seek to contest.

The new lawsuit arrives amid a shifting legal and political landscape for reproductive health following developments at the Supreme Court and in state legislatures. Court challenges of federal regulatory choices can be slow moving, but the potential for injunctions or rulings that alter distribution and prescribing practices makes the litigation consequential. For providers and patients the litigation represents another layer of uncertainty in access to medication abortion.

The case will proceed in the federal district court in Wichita Falls, where initial motions and scheduling orders are likely to shape how quickly the dispute reaches higher courts. Observers say the procedural posture and the plaintiffs’ ability to establish standing will be key determiners of whether this challenge ultimately results in changes to federal oversight of mifepristone.