Overview

• Kennedy and FDA Commissioner Marty Makary told 22 Republican attorneys general the FDA will conduct its own assessment of safety, efficacy and dispensing conditions for mifepristone.
• Officials said potential changes to Risk Evaluation and Mitigation Strategy requirements are under consideration, though no regulatory actions have been announced.
• Kennedy told senators the safety review is underway with new data being collected and alleged the prior administration downplayed a safety signal without offering specifics.
• The agencies cited recent research including an EPPC analysis that reported roughly 11% serious adverse events, a non–peer-reviewed finding that conflicts with clinical literature and FDA figures near 0.5%.
• Medication abortion now accounts for a majority of U.S. abortions, with advocates warning that curbs on telehealth or mailing could sharply reduce access as some states, such as Texas, pursue enforcement against shipment of the drugs.