Overview

• FDA Commissioner Marty Makary formally committed to a postmarketing safety review of mifepristone after receiving a letter from Sen. Josh Hawley.
• An April study by the Ethics and Public Policy Center reported that 11 percent of medication abortions resulted in serious adverse events, a claim that prompted Hawley’s request.
• Medical experts have criticized the EPPC report for lacking peer review and methodological transparency and cite over 100 studies showing serious complications occur in fewer than 1 percent of cases.
• Health and Human Services Secretary Robert F. Kennedy Jr. also directed the FDA earlier this month to conduct a complete review of mifepristone regulations.
• The agency’s decision could reshape access to medication abortions nationwide, as mifepristone is used in roughly two-thirds of U.S. abortions and faces multiple legal challenges.