Overview
- Sen. Bill Cassidy led 16 colleagues in a letter to FDA Commissioner Marty Makary seeking documents and answers on the agency’s decision to clear Evita Solutions’ generic mifepristone.
- The letter asks whether the FDA extended the statutory review timeline and why the generic was cleared before the agency completed its safety review of mifepristone.
- Evita Solutions filed its application in October 2021, and the FDA approved the bioequivalent generic on Sept. 30, 2025, allowing the telehealth provider to begin production.
- HHS officials say the department has very limited discretion on generic approvals and is conducting a study of reported adverse effects, adding that it will respond directly to the senators.
- Anti-abortion groups praised the oversight push as they cite contested analyses reporting higher complication rates and raise concerns tied to the removal of in‑person screening requirements.