US EditionFDA Commissioner Pledges to Investigate Mifepristone
- On June 4, 2025, FDA Commissioner Marty Makary announced plans to reassess the safety profile of the abortion drug mifepristone in response to new concerns highlighted by a recent study.
- This review was initiated following a study referenced by Senator Josh Hawley, conducted by a policy research organization, which reported that nearly 11% of women experienced serious complications such as sepsis, infection, or hemorrhaging after using the medication.
- Drawing from an analysis of nearly 866,000 mifepristone abortions recorded between 2017 and 2023, the study reported rates of side effects such as sepsis, infection, and hemorrhaging that greatly surpass the risks indicated on the FDA label; however, the findings have not undergone peer review.
- Makary expressed his dedication to thoroughly reviewing the data on mifepristone alongside FDA career scientists, emphasizing that the agency maintains ongoing surveillance of the drug’s safety after its approval, even as critics question the study’s methods and conclusions.
- The review could influence future regulatory decisions amid ongoing legal challenges and political debate, but its impact on drug access remains unclear at this time.
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41 Articles
The Killeen Daily Herald
RFK Jr. Calls for a Review of Abortion Pill Mifepristone
Key Takeaways
FDA Commissioner ‘Committed’ to Conducting Abortion Pill Review
Makary committed to a review of the drug in a letter responding to Sen. Josh Hawley's (R-MO) concerns about mifepristone, following a the release of a new study suggesting real-world complications from the pill are 22 times higher than what is listed on the FDA-approved drug label.
FDA to "review the latest data" on mifepristone. What could it mean for access to the abortion pill?
HHS Secretary Robert F. Kennedy Jr. asked the FDA "to review the latest data on mifepristone," but experts say concerns about the abortion pill's safety are misguided.
Thanks to These Stellar Men and a Bogus Study, the FDA Will Needlessly Investigate the Abortion Pill
A round of boos is in order for Sen. Josh Hawley (R-Mo.), who’s successfully used his platform as a United States lawmaker to publicize bogus research from a far-right organization to pressure the Food and Drug Administration into needlessly reviewing the safety of the abortion pill. Boos are always in order for Hawley, but he deserves a lot more of them this week. In April, Hawley wrote a letter to Dr. Marty Makary, the head of the FDA, alertin…
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