In Purcell v. Kennedy, (D HI, Oct. 30, 2025), a Hawaii federal district court, in a 79-page opinion, held that the FDA must re-evaluate the “Risk Evaluation and Mitigation Strategy” which it has imposed for the use of mifepristone. The court said in part:
… [T]he court concludes that the Agency violated the APA by failing to provide a reasoned explanation for its restrictive treatment of the drug, which was compounded by its decision to limit the scope of information it considered when evaluating the REMS. More specifically, the Agency neglected to consider certain required statutory factors and generally failed to sufficiently explain the logic behind any reasoning it did provide, rendering the 2023 REMS Decision arbitrary and capricious.
The court ordered the FDA to reconsider its restrictions. ACLU issued a press release announcing the decision. [Thanks to Thomas Rutledge for the lead.]