Overview
- In September, the FDA approved Evita Solutions’ generic mifepristone, a key drug used in medication abortions.
- Sen. Josh Hawley and Sen. Bill Cassidy, joined by SBA Pro-Life America, publicly demanded explanations and tighter safeguards after saying their letter’s Oct. 30 response deadline passed without an agency reply.
- HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Martin Makary have pledged to review real‑world safety data, and Kennedy says federal law requires approval of generics that prove bioequivalence.
- Critics cite an Ethics & Public Policy Center analysis of 865,000 cases that reports higher rates of serious complications than the FDA label, a conclusion disputed by other reviewers.
- Republican lawmakers are urging reinstatement of in‑person dispensing rules as debates continue over telehealth and mail distribution, with Cassidy signaling plans to question FDA officials about the decision.