• FDA Commissioner Marty Makary agrees to review the safety of mifepristone.
• The review follows pressure from Senator Josh Hawley and a report claiming high adverse event rates related to the drug.
• Major medical organizations have emphasized mifepristone's safety, citing over 100 studies.

The Food and Drug Administration (FDA) is set to conduct a safety review of mifepristone, the abortion pill, following a letter from Commissioner Marty Makary to Senator Josh Hawley (R-Mo.). In this letter, Makary stated that the FDA "continues to closely monitor the postmarketing safety data on mifepristone for the medical termination of early pregnancy" and expressed his commitment to involving professional career scientists in the review process, according to The Hill.

This announcement comes amidst ongoing political tension and pressure from Hawley, who has criticized the FDA's previous reluctance to act on mifepristone's safety. The impetus for this review appears to be linked to a controversial report from the Ethics and Public Policy Center, which claims that nearly 11% of women may experience serious adverse events associated with mifepristone abortions, a claim heavily disputed for lacking scientific rigor, according to HuffPost and CBS News.

Experts, including Dr. Angel Foster and Dr. Céline Gounder, have raised concerns about the validity of the EPPC findings, noting that significant numbers reported in the study are misleading. "Adverse events" such as normal bleeding experienced during medication abortions should not be classified as complications unless they require significant medical intervention. The report's methodology and its lack of peer review further underscore its questionable validity, according to HuffPost and CBS News.

The FDA has reassured the public that mifepristone was initially approved in 2000 after extensive safety evaluations and that periodic reviews since then have shown no new concerns, reinforcing its status as a safe option for medication abortion for over 5 million patients, according to HuffPost and CBS News.

Despite these reassurances, the political landscape surrounding mifepristone remains severed, as it has been subjected to various legal challenges aimed at restricting access, especially after the reversal of Roe v. Wade. In 2024, the Supreme Court dismissed a case targeting mifepristone's availability, affirming that the FDA had acted lawfully in its approval and regulation processes, according to The Hill and CBS News.