HHS Orders FDA Review of Mifepristone

Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary ordered a new FDA review of the abortion drug mifepristone in a Sept. 19 letter to 22 Republican attorneys general, saying the agency will examine 'real‑world outcomes' related to the drug’s safety and efficacy. HHS and GOP officials said the probe was prompted by requests from state attorneys general and recent studies — including one from the Ethics and Public Policy Center that HHS cited — alleging higher rates of serious adverse events than reported on the label. Officials said the review could lead to changes to the drug’s Risk Evaluation and Mitigation Strategy, including reinstating in‑person dispensing and curbing telehealth or mailing of pills. Abortion‑rights groups warn such moves would sharply reduce access in states with abortion bans, while medical groups and other experts say mifepristone has been used safely for decades and call the review politically motivated. The FDA has not announced any regulatory changes; medication abortions currently account for roughly 60–63% of U.S. abortions, making any policy shift consequential for access.