FDA Administrator maintaining no intentions for alterations in abortion pill policy, persisting with safety evaluation process.
In the realm of reproductive healthcare, the Food and Drug Administration (FDA) is currently conducting a safety review of the abortion pill, mifepristone. The review comes in response to ongoing data, with the recent controversy surrounding a report by the Ethics and Public Policy Center (EPPC) that has been criticized for its methodological flaws.
Mifepristone, a medication designed to end a pregnancy in the first 10 weeks, has been a subject of debate due to the EPPC report, which suggests a higher rate of serious health complications than previously established. However, experts and medical organizations, including the American College of Obstetricians and Gynecologists, warn that relying on such politicized data could severely hinder access to a medication abortion method shown to be safe and effective.
Commissioner Marty Makary of the FDA has stated that he has no preconceived plans to modify policies surrounding mifepristone. This stance was reiterated during the Semafor World Economy Summit in April, and he continues to uphold it as of late July 2025. Makary emphasizes the importance of "gold standard science" and data-driven decisions, maintaining an open-minded approach while listening to differing opinions.
The FDA and biotech leaders uphold that mifepristone is a highly studied medication, with over 100 peer-reviewed studies supporting its safety and efficacy, comparable in risk to commonly prescribed antibiotics and NSAIDs. The ongoing safety review by the FDA is a requirement from prior administrations, and Makary has stated that the FDA would not hesitate to act if the data suggested there was a safety issue with mifepristone.
Senator Josh Hawley, R-Mo., expressed safety concerns about mifepristone in an April 28 letter to Commissioner Marty Makary, urging him to take action to restore critical safeguards on the use of mifepristone. The U.S. Supreme Court will take up a case that could impact how women get access to mifepristone on Tuesday, March 26, 2024.
The FDA and Senator Hawley were contacted for comment by our website Digital, but no response was received at the time of publication.
Mifepristone, along with Misoprostol, are the two drugs used in a medication abortion. As the FDA continues its safety review, experts urge the FDA to rely on rigorous, peer-reviewed science rather than politicized data to ensure that safe and effective reproductive healthcare options remain accessible.
References:
- Guttmacher Institute. (2022). Mifepristone: What you need to know. https://www.guttmacher.org/fact-sheet/mifepristone
- American College of Obstetricians and Gynecologists. (2022). Abortion: Comprehensive clinical guidance. https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2022/08/medication-abortion-comprehensive-clinical-guidance
- Makary, M. (2022). FDA commissioner: No plans to restrict access to abortion pill mifepristone. CNN. https://www.cnn.com/2022/04/27/politics/fda-mifepristone-abortion-pill-marty-makary/index.html
Adam Sabes is a writer for our website Digital and can be reached at [email protected] and on Twitter @asabes10.
- The Food and Drug Administration (FDA) is currently reviewing the safety of the abortion pill, mifepristone, amidst ongoing data and a controversial report by the Ethics and Public Policy Center (EPPC).
- Mifepristone, a medication used in medication abortions, has been under scrutiny due to the EPPC report, which suggests a higher rate of serious health complications compared to previously established data.
- Commissioner Marty Makary of the FDA has stated that he has no preconceived plans to modify policies surrounding mifepristone and continues to uphold an open-minded approach, emphasizing the importance of "gold standard science" and data-driven decisions.
- The FDA and Senator Josh Hawley, R-Mo., have expressed differing opinions regarding the safety of mifepristone, with Senator Hawley expressing concerns and urging the FDA to take action.
- Experts urge the FDA to rely on rigorous, peer-reviewed science and refrain from political influences to ensure that safe and effective reproductive healthcare, such as medication abortion methods like mifepristone, remain accessible.
