Health and Human Services Secretary Robert F. Kennedy Jr. has directed the Food and Drug Administration (FDA) to conduct a full review of the abortion drug mifepristone, following the release of a study indicating the drug may pose significantly greater health risks to women than previously reported.
Speaking during a Senate Health, Education, Labor, and Pensions Committee hearing on Wednesday, Kennedy referenced a recent study from the Ethics & Public Policy Center (EPPC), which found that nearly 11% of women who took the drug experienced a serious adverse event, as reported by The New York Post.
“It’s alarming,” Kennedy told lawmakers. “I have asked Marty Makary, who is the director at FDA, to do a complete review and report back.”
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The EPPC study — described as the largest known analysis of mifepristone usage — reviewed insurance claims for 865,727 chemical abortions using mifepristone between 2017 and 2023.
The findings showed that 10.93% of women suffered from complications such as hemorrhage, infection, sepsis, or other serious medical conditions within 45 days of taking the drug.
Sen. Josh Hawley (R-Mo.) cited the study during questioning and noted the reported complication rate is 22 times higher than what is currently listed on the FDA’s label for mifepristone, which indicates a 0.5% rate for serious adverse events.
“Clearly [the study] indicates, at the very least, that the label should be changed,” Kennedy said in response to Hawley’s remarks.
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Originally approved by the FDA in 2000, mifepristone was initially authorized for use within seven weeks of pregnancy. That window was later extended to 10 weeks under former President Barack Obama.
The Biden administration further expanded access, allowing prescriptions to be issued online or through the mail — a policy upheld by the Supreme Court in a unanimous ruling last year.
The Ethics & Public Policy Center has called for the FDA to take additional steps to protect patient safety, including mandating more comprehensive reporting of adverse effects and requiring physician oversight for any use of mifepristone.
“The FDA should further investigate the harm mifepristone causes to women and, based on objective safety criteria, reconsider its approval altogether,” the EPPC stated in its findings.
Kennedy did not give a timeline for the FDA’s review, but the announcement signals a shift in the federal government’s approach to chemical abortion drug regulation under his leadership.
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