FDA approves mifepristone for medication abortion up to 49 days gestation

The FDA approves mifepristone under the brand name Mifeprex for termination of pregnancy through 49 days gestation, but places it under a Risk Evaluation and Mitigation Strategy (REMS) — a special safety program used for high-risk drugs. The REMS requires that the drug only be dispensed in person at a certified clinic, hospital, or medical office, and bars pharmacies from dispensing it. The in-person dispensing restriction becomes the central target of both subsequent expansion efforts by abortion rights advocates and preservation efforts by anti-abortion litigants. The approval comes after eight years of regulatory limbo since the French approval, demonstrating how the regulatory process itself can delay access indefinitely.