Robert F. Kennedy Jr., Health and Human Services (HHS) Secretary, announced a new FDA review of mifepristone, a key medication used in abortions, following pressure from Republican states and attorneys general.
Mifepristone, typically paired with misoprostol, is the primary drug for medication abortion in the U.S., making up nearly two-thirds of all abortions nationally.
The big picture: Medication abortion remains critical in states where abortion is banned or heavily restricted, facilitated largely by telehealth appointments and shield laws allowing cross-state mailing of abortion pills.
- Republicans and anti-abortion advocates pushed the Trump administration to reconsider FDA rules governing mifepristone’s safety and distribution.
- The new review aims to assess the drug’s real-world safety and efficacy, responding to concerns raised by 22 Republican attorneys general.
- Kennedy and FDA Commissioner Marty Makary stated they would “thoroughly investigate” conditions for safe dispensing of mifepristone to ensure women’s health protection.
Go deeper: The review is partly based on a conservative think-tank study by the Ethics and Public Policy Center, which reported an 11% rate of serious adverse events – far higher than the FDA’s stated 0.5% based on clinical trials.
- Kennedy described the study as “alarming” and expressed openness to changing the medication label, but no immediate policy changes have been committed.
- Mifepristone works by blocking progesterone, essential for pregnancy continuation, and was FDA-approved in 2000 for use up to seven weeks gestation, later extended to 10 weeks; the WHO supports use up to 12 weeks.
- The FDA approved a generic form of mifepristone in 2019.
- Data from the CDC shows medication abortions increased from 19% in 2011 to 57% in 2022.
