The Trump administration is officially reviewing the safety of abortion drug mifepristone after pressure from Republican lawmakers.
The Food and Drug Administration is initiating the review of mifepristone’s safety months after Health and Human Services Secretary Robert F. Kennedy Jr. promised to undertake the investigation in response to a bombshell study which found that the commonly used abortion drug is much less safe than advertised.
Kennedy and Makary told Republican Attorneys General in a letter that the FDA is conducting “its own review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy of the drug,” according to multiple reports.
“The concerns you have raised in your letter merit close examination. This Administration will ensure that women’s health is properly protected by thoroughly investigating the circumstances under which mifepristone can be safely dispensed,” Kennedy and FDA Commissioner Marky Makary wrote to the GOP AGs.
NR has reached out to HHS for comment.
Makary told Senator Josh Hawley (R., Mo.) in June that the FDA would review the safety of mifepristone but declined to comment on specifics because of ongoing litigation. His commitment to review mifepristone was a shift from his declaration in April that he would not take action on mifepristone for the time being.
“This FDA review of the abortion drug is long promised and much needed. Almost 70% of abortions in America are chemical abortions, and there are no meaningful safety restrictions on the drug currently in place. FDA should reinstate safety rules ASAP,” Hawley said.
The FDA’s action follows a major study from the conservative Ethics and Public Policy Center showing mifepristone’s is less safe than previously thought. EPPC found that almost 11 percent of women experience a serious adverse effect within 45 days of taking mifepristone, which is 22 times higher than the FDA label on the drug suggests. Serious adverse effects include sepsis, infection, and hemorrhaging.
Kennedy previously floated the possibility of having the FDA change mifepristone’s label because of EPPC’s findings. The study analyzed an insurance claims database with 865,727 prescribed mifepristone abortions from 2017-23, a sum much larger than the combined sample of FDA-cited studies.
Abortion advocates have dismissed the EPPC study as a non-peer reviewed, unscientific paper. Pro-abortion groups falsely argue that mifepristone is safer than Tylenol and other commonly used medications.
The availability of mifepristone has become a central battle in the broader abortion fight as women living in states with abortion bans increasingly turn to the drug. A study from the pro-abortion Guttmacher Institute in 2024 found that almost 70 percent of abortions were carried out through the abortion pill in 2023.
Numerous Republican states have passed abortion restrictions and barred the use of mifepristone, but Democratic states have strongly embraced abortion tourism and the delivery of abortion pills across state lines to undercut those restrictions.