FDA commissioner reviews safety of abortion drug mifepristone amid concerns

In the United States, on June 4, 2025, Food and Drug Administration Commissioner Marty Makary announced plans to review the safety of mifepristone, an abortion drug, following a recent study that reported alarming medical side effects. The study, conducted by the Ethics and Public Policy Center, indicated that 11% of women who used mifepristone experienced severe issues such as sepsis, infection, or hemorrhaging within 45 days post-administration. This figure was notably higher than what is currently stated on the drug's official label, as it was reported to be 22 times greater. U.S. Senator Josh Hawley, a Republican from Missouri, initially brought this study to Makary’s attention. In his communication with the FDA commissioner, Hawley expressed his concerns regarding the significant discrepancy between the actual side effects reported in the study and those identified on the mifepristone label. He urged the FDA to reinstate safety regulations for the drug immediately, implying that the existing guidelines might not sufficiently protect women who opt for medical abortions. The urgency communicated by Hawley highlights ongoing debates over reproductive health regulations and the importance of stringent oversight by the FDA. Makary, during his Senate confirmation hearing earlier in 2025, previously indicated he would oversee a review of mifepristone but had not taken action until informed about the study by Hawley. His commitment, as stated in his letter to Hawley, includes collaboration with the FDA's professional career scientists to ensure a thorough examination of the data concerning mifepristone’s safety profile. When addressing the senators, Makary mentioned that the agency is committed to consistently monitoring the post-marketing safety data associated with mifepristone, emphasizing the FDA's responsibility in safeguarding public health. The backdrop of this issue also includes a larger narrative concerning abortion access in the United States. Earlier in 2025, the Biden administration had introduced policies that permitted women to obtain abortion drugs without requiring in-person medical appointments, which some critics argue may pose safety risks. As a result, this review led by Makary may set precedent for future regulations regarding medical abortion and safety, particularly in a polarized political landscape where views on abortion rights are deeply divided. Moreover, in response to this study and the ensuing conversation, it is likely that the review will spark renewed discussions among policymakers and healthcare professionals about the safety and regulation of medical abortion drugs like mifepristone.