Health and Human Services Secretary Robert F. Kennedy Jr. has requested that the Food and Drug Administration conduct a full review of the abortion pill mifepristone, citing recent data that raise serious safety concerns. The announcement came during a Senate hearing Wednesday, where Kennedy responded to questions from Sen. Josh Hawley (R-MO) about new findings on the drug’s risks.
Kennedy acknowledged he was aware of the alarming statistics indicating that mifepristone is far more dangerous than previously reported. “It’s alarming,” Kennedy told lawmakers. “Clearly, it indicates that at the very least the label should be changed.” He confirmed he had asked FDA Director Dr. Marty Makary to launch a comprehensive review and report back with findings. He did not provide a specific timeline for completion.
The decision follows recent analyses showing that more than 1 in 10 women who took mifepristone in 2023 experienced a “serious adverse event,” including hemorrhaging, emergency room visits, and potentially life-threatening complications like sepsis. That figure is 22 times higher than the FDA’s current label, which lists the risk of serious complications at less than 0.5%.
Another recent analysis found that over 5% of women required a second procedure after the abortion pill failed to complete the abortion—posing additional physical and emotional risks. Mifepristone is typically followed by a second drug, misoprostol, in a two-pill regimen intended to terminate and expel the pregnancy. However, failures in the process can leave fetal tissue behind, leading to further medical issues.
These new safety concerns are amplified by the FDA’s 2021 decision to remove the requirement for in-person medical visits before receiving abortion pills, instead allowing online prescriptions and mail delivery. Critics argue that this change, made under the banner of access and convenience, removed essential safeguards and increased the likelihood of complications going undetected until it’s too late.
Pro-life advocates have welcomed Kennedy’s call for accountability. “We applaud Robert F. Kennedy Jr. for his swift directive to FDA for a thorough study of the dangerous chemical abortion pill,” said Doug Truax, founder of the Foundation for the Restoration of America. “The health and safety of women is at risk and we can’t allow ideology to trump science.”
RFK Jr.’s evolving stance on abortion has been under the microscope since he took the helm of HHS. While he has described abortion as a “tragedy,” he has also maintained that it’s a “complex” issue and has previously stated he does not support the state dictating decisions to women. That tension was on display in a past interview where he told a commentator, “I understand that position, and I don’t agree with it,” when pressed about the moral implications of abortion.
Kennedy also appeared before the House to defend the Trump administration’s proposed budget cuts to HHS, stating that while the reductions would be “painful,” they would help reduce federal spending without compromising critical services.
The growing body of evidence around mifepristone’s safety profile places new pressure on the FDA to respond with integrity, rather than political expediency. If this review is conducted thoroughly and transparently, it could mark a critical shift toward reclaiming medical oversight and protecting vulnerable women from the consequences of underregulated chemical abortion methods.
