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# Court Finds Mifepristone REMS ‘Unlawful’
- URL: https://www.fdaweb.com/court-finds-mifepristone-rems-unlawful/
- Published: 2025-10-30T12:00:00.000Z
- Updated: 2026-09-14T15:25:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160140

A U.S. District Court in Hawaii [ruled 10/20 ](https://assets.aclu.org/live/uploads/2017/10/2025.10.30-Purcell-v.-Kennedy-Opinion.pdf?ref=fdaweb.com)that FDA acted unlawfully by imposing certain restrictions on mifepristone. The court found the FDA failed to provide a reasoned explanation for its restrictive regulation of the medication. The case centered on an agency-mandated Risk Evaluation and Mitigation Strategy (REMS), which subjects the drug to stricter regulations than many other medications. These include special certification requirements for prescribers and pharmacies.

The lawsuit was filed by the American Civil Liberties Union on behalf of a Hawaii doctor and several health care associations. They argued that the REMS restrictions were medically unnecessary and disproportionately impacted patients in rural areas or with low income. While the court found FDA's rationale to be unlawful, the ruling does not immediately eliminate all current restrictions on mifepristone. The matter has been remanded to FDA to reconsider the mifepristone REMS.