Overview

• Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary told 22 Republican attorneys general in a Sept. 19 letter that the FDA is conducting its own review of mifepristone’s safety, efficacy and dispensing conditions.
• The agencies referenced an Ethics and Public Policy Center analysis claiming roughly 11% serious adverse events, a report that is not peer‑reviewed and has been criticized by medical experts and the Society of Family Planning for methodological flaws and opaque data.
• HHS said the review includes evaluating the current Risk Evaluation and Mitigation Strategy for mifepristone to determine whether modifications are needed to ensure it is safely dispensed.
• Abortion‑rights groups condemned the effort as political and warned it could lead to measures such as reinstating in‑person prescribing that would curtail telehealth and mail‑order access.
• FDA data show about five deaths per 1 million users since 2000, and CNN’s analysis notes the drug’s risk profile compares favorably with common medications; medication abortion accounts for more than half of U.S. abortions.