State of Florida et al. v. Food and Drug Administration et al.

Docket No.
7:25-cv-00126
District Court
Texas Northern

Goal

  • Block enforcement of an agency action
  • Declaration that agency action is unlawful
  • Vacate agency action

Litigation Content

Why this Matters

The states allege that the Food and Drug Administration’s (FDA’s) approval of mifepristone as safe and effective and the agency’s subsequent changes to the regulation of this medication violate the Administrative Procedure Act; the Food, Drug, and Cosmetic Act; the Comstock Act; and the Pediatric Research Equity Act. Ensuring access to FDA-approved medication abortion enables patients to receive reproductive health care.

Potential Impact

Preventing women from accessing effective medication for abortion services will jeopardize their health and safety. Additionally, preventing the FDA from making clinical and scientific determinations will endanger the agency’s ability to ensure individuals have access to safe and effective drugs.

Litigation Information

Current Status

Briefing is ongoing