Politics, Science, and the Future of FDA Drug Regulation: FDA’s Review of Mifepristone REMS as a Litmus Test

On September 19, 2025, US Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr and US Food and Drug Administration (FDA) Commissioner Martin Makary announced that HHS would be conducting “a study on the safety of the current [Risk Evaluation and Mitigation Strategy (REMS)]” for mifepristone to “determine whether modifications are necessary.” This announcement came in response to a letter from the attorneys general of 22 states, seeking a review of the mifepristone REMS. Secretary Kennedy and Commissioner Makary wrote that their decision was “informed by the lack of adequate consideration underlying the prior REMS approvals” and further justified their review in light of “recent studies raising concerns about the safety of mifepristone as currently administered” that the attorneys general had cited in their letter.

If the history of the FDA’s management of mifepristone’s REMS requirements is marked by caution—reliant on agency staff and experts and driven by scientific evidence rather than political interference—the current administration’s first year suggests an opposite approach.