Judge: FDA mifepristone limits unlawful; no change yet
U.S. District Judge Jill Otake in Hawaii ruled Oct. 30 that the FDA violated the Administrative Procedure Act by failing to adequately justify its 2023 decision to keep special REMS restrictions on mifepristone, used for abortion and miscarriage care. The court ordered FDA to reconsider evidence it allegedly disregarded, but left current restrictions in place for now; the ACLU brought the case and says the limits burden access, while DOJ did not immediately comment.
📌 Key Facts
- Ruling: FDA’s 2023 mifepristone REMS maintained without a reasoned explanation, violating the APA
- Current restrictions include prescriber/pharmacy certification and a required counseling form; the in‑person pickup rule was previously removed and mailing is allowed
- Order instructs FDA to reconsider relevant evidence; restrictions remain pending further agency action