State of Louisiana v. FDA

── State of Louisiana v. FDA ── Court: Court of Appeals for the Fifth Circuit Date: May 01, 2026 Category: United States Civil Case: 26-30203 Document: 119-1 Page: 1 Date Filed: 05/01/2026 United States Court of Appeals for the Fifth Circuit _____________ No. 26-30203 _____________ State of Louisiana, by & through its Attorney General, Liz Murrill; Rosalie Markezich, Plaintiffs—Appellants, versus Food & Drug Administration; Marty Makary, Commissioner, U.S. Food and Drug Administration; Richard Pazdur, in his official capacity as Director, Center for Drug Evaluation & Research, U S Food & Drug Administration; United States Department of Health and Human Services; Robert F. Kennedy, Jr., Secretary, U.S. Department of Health and Human Services, Defendants—Appellees, versus Danco Laboratories, L.L.C.; GenBioPro, Incorporated, Intervenors—Appellees. ________________________________ Appeal from the United States District Court for the Western District of Louisiana USDC No. 6:25-CV-1491 ________________________________ Case: 26-30203 Document: 119-1 Page: 2 Date Filed: 05/01/2026 No. 26-30203 Before Southwick, Duncan, and Engelhardt, Circuit Judges. Stuart Kyle Duncan, Circuit Judge: In Dobbs v. Jackson Women’s Health Organization, 597 U.S. 215 (2022), the Supreme Court returned the regulation of abortion to the states. In response, the Biden Administration directed federal agencies to “expand access to . . . medication abortion.” Exec. Order No. 14076, 87 Fed. Reg. 42053 (July 8, 2022). The next year, the Food and Drug Administration (FDA) formally altered its safety guidelines for the abortion drug mifepristone. Under the new regulation, the drug could now be prescribed online and dispensed through the mail, without any need for an in-person visit to a doctor. In 2025, Louisiana challenged the new regulation in federal court under the Administrative Procedure Act (APA). It argued that FDA’s justifications for remotely dispensing mifepristone were based on flawed or nonexistent data. It also documented how the new regulation had resulted in numerous illegal abortions in Louisiana and in Louisiana paying thousands in Medicaid bills for women harmed by mifepristone. Louisiana sought a stay of the regulation while the litigation proceeded. In response, FDA conceded it had failed to adequately study whether remotely prescribing mifepristone is safe. But the agency resisted staying the regulation, arguing it was in the midst of a comprehensive review of mifepristone protocols. The agency, however, could not say when that review might be complete and admitted it was still collecting data. The district court agreed that Louisiana was likely to win its challenge to the mifepristone regulation and was suffering irreparable harm from it. Nonetheless, the court declined to stay the regulation based on its balancing of the equities and the public interest. Louisiana appealed to our court and sought a stay pending appeal under 5 U.S.C. § 705. 2 Case: 26-30203 Document: 119-1 Page: 3 Date Filed: 05/01/2026 No. 26-30203 We grant the stay. I We briefly describe (A) FDA’s actions with respect to mifepristone, (B) prior challenges to those actions, and (C) the present suit. A FDA determines whether drugs are safe and effective before they can be marketed in the United States. See Federal Food, Drug, and Cosmetic Act, ch. 675, 52 Stat. 1040 (1938) (FDCA); FDA v. Al