Overview

• HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary told 22 Republican attorneys general the FDA is conducting its own assessment of mifepristone’s safety, efficacy and dispensing conditions using real-world data.
• FDA data show about five deaths per 1 million users since 2000 and major medical groups describe the medication as safe, while a non–peer-reviewed Ethics & Public Policy Center analysis cited by critics has been widely faulted by researchers.
• Mifepristone remains under an FDA REMS “closed system” that requires certified prescribers and pharmacies, and access expanded in recent years through telehealth and mail dispensing.
• The review follows renewed political pressure and comes shortly after the FDA cleared another generic version in September, with opponents urging restrictions on telemedicine and mail-order distribution.
• Ohio’s 2024 data report medication abortion in more than 46% of cases with 196 complications and no deaths, and legal experts note that the federal review is ongoing and policy has not changed.