Reported / Citable
Background
Florida and Texas sued the FDA and federal officials under the Administrative Procedure Act, challenging the FDA’s 2000 approval of mifepristone, its 2016 changes to the drug’s risk-management restrictions, its 2021 and 2023 removal of in-person dispensing requirements, and approvals of generic mifepristone. The states alleged that the actions violated the Federal Food, Drug, and Cosmetic Act, the Pediatric Research Equity Act, and the Comstock Act.
The states alleged economic injuries from Medicaid expenditures for treatment of adverse events and enforcement costs related to mail-order abortions. They also asserted sovereign and quasi-sovereign injuries, arguing that the FDA actions interfered with their abortion restrictions. The FDA sought a stay while it reviews the challenged actions; Danco Laboratories and GenBioPro, mifepristone manufacturers that intervened in the case, moved to dismiss.
The Court’s Holding
The court denied the manufacturers’ dismissal motions. It held that Texas was not precluded by a Ninth Circuit ruling in separate litigation from establishing standing here, because Fifth Circuit precedent issued afterward supplied a materially different standing analysis. Applying that precedent, the court found that the states plausibly alleged economic and sovereign injuries sufficient for Article III standing.
The court also held that the states fell within the relevant statutes’ zones of interest, need not file redundant citizen petitions, and had plausibly alleged timely claims. It further found the claims ripe because they challenge final agency actions. With the parties agreeing that a limited pause would promote efficiency during the FDA’s substantive review, the court stayed the action until the earlier of December 1, 2026, or completion of that review.
Key Takeaways
- The court held that Florida and Texas may pursue their APA challenge to the FDA’s mifepristone-related actions.
- Alleged Medicaid costs and interference with state abortion-law enforcement were sufficient at the pleading stage to support standing.
- The case is paused, not dismissed; the parties must submit a joint status report within seven days after the stay expires.
Why It Matters
The order keeps alive a broad state challenge to longstanding FDA decisions concerning mifepristone while the agency reassesses those decisions. It also applies recent Fifth Circuit standing precedent to state claims based on health-care costs and asserted interference with state abortion restrictions.