Overview

• In a letter made public Tuesday, Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary told 22 Republican attorneys general the agency will conduct its own safety and efficacy review of mifepristone and is considering changes to its Risk Evaluation and Mitigation Strategy.
• The officials have not signaled removing the drug from the market, which the FDA approved in 2000 and later made more accessible through 2016 and 2021 actions including telehealth prescribing and mailing.
• Their letter cites recent studies, including a non–peer‑reviewed analysis from the Ethics and Public Policy Center that claims nearly 11% serious adverse events, far above rates reported in clinical research and on the FDA label.
• Medication abortion now accounts for a majority of U.S. abortions, and any REMS tightening could restrict telehealth, mail delivery, or the gestational window, changes that providers say would sharply reduce access.
• Hey Jane’s CEO and Planned Parenthood cautioned that leaning on contested research risks undermining access to a well‑studied regimen widely used for abortion and miscarriage care.