The Commissioner of the Food and Drug Administration is promising a full agency review of the safety of chemical abortion drug mifepristone after a new study raised concerns about its effects.
FDA Commissioner Marty Makary wrote a letter to pro-life Senator Josh Hawley (R., Mo.) Monday informing him of the agency’s plan to conduct a review of mifepristone.
“As with all drugs, FDA continues to closely monitor the postmarketing safety data on mifepristone for the medical termination of early pregnancy,” Makary said.
“As the Commissioner of Food and Drugs, I am committed to conducting a review of mifepristone and working with the professional career scientists at the Agency who review this data.”
Makary declined to comment further because the use of mifepristone for chemical abortions remains the subject of ongoing litigation.
The Supreme Court last year rejected a challenge to the FDA’s approval of mifepristone, ruling that the pro-life doctors who brought the case lacked standing. Now, abortion providers are suing in federal court to get the FDA to lift restrictions around the prescription of mifepristone.
Hawley previously made Makary aware of a study from the conservative Ethics and Public Policy Center showing mifepristone is much less safe than previously thought. The EPPC found that almost 11 percent of women experience a serious adverse effect within 45 days following a mifepristone abortion, a figure 22 times higher than its current label indicates. The serious adverse events from mifepristone include sepsis, infection, and hemorrhaging, the EPPC observed.
“I’m calling on the FDA to reinstate safety regulations on the chemical abortion drug immediately. New data out today show a massive number of severe medical side effects,” Hawley said.
The think tank’s study is based on an analysis of an insurance claims database with 865,727 prescribed mifepristone abortions from 2017-23, a sample that dwarfs the size of all FDA-cited clinical trials on the abortion drug put together. A separate paper from the pro-life Charlotte Lozier Institute published last week debunked the popular abortion industry narrative that mifepristone if safer than tylenol, a claim that was common when mifepristone’s fate was in the hands of the Supreme Court.
Makary’s commitment to oversee a review of mifepristone follows Health and Human Services Secretary Robert F. Kennedy’s promise to Hawley that he would instruct Makary to review mifepristone. Kennedy also told Hawley the FDA should change the label on mifepristone to reflect the EPPC data on its health effects.
Before the EPPC study’s release, Makary said he did not plan on taking action to restrict mifepristone, but left open the possibility of future action if new data warranted it. At his confirmation hearing, Makary voiced concerns about the Biden administration’s policy of allowing women to get abortion drugs without making an in-person appointment. He told Senators that he would oversee a review of mifepristone without committing to anything specific.
President Donald Trump took a moderate position on abortion during the 2024 campaign due to the popular backlash to the Supreme Court’s overturning of Roe v. Wade and red state abortion restrictions. Trump promised not to touch the accessibility of mifepristone and supported the Supreme Court’s decision to throw out the mifepristone case last year due to lack of standing.
The Supreme Court’s ruling and Trump’s position on abortion were disappointments for pro-lifers concerned about the proliferation of abortion drugs. As such, Hawley has urged the Trump administration to reconsider its hands-off position on mifepristone given the new EPPC data.
Chemical abortions are an increasingly common method for pregnant women seeking to end their pregnancies. Data from the pro-abortion Guttmacher Institute shows medication abortions made up 63 percent of all abortions in 2023, a 10 percent increase over the previous three years, despite the overturning of Roe in 2022.