Health and Human Services Secretary Robert F. Kennedy Jr. said Wednesday the Food and Drug Administration should change the label on abortion drug mifepristone and conduct a top-to-bottom review of the pill after a new study showed the risks of serious side effects are greater than previously thought.
Senator Josh Hawley (R., Mo.) asked Kennedy about mifepristone during a Senate Health, Education, Labor, and Pensions Committee hearing, where he cited a study from the conservative Ethics and Public Policy Center that found nearly 11 percent of women suffered a serious adverse effect from the abortion drug.
“You have said you will do a top-to-bottom review. Do you continue to stand by that, and don’t you think that this new data shows the need to do a review is in fact very pressing?” Hawley asked Kennedy.
“It’s alarming,” Kennedy said of the EPPC data.”Clearly, it indicates that at the very least, the label should be changed. I’ve asked Marty Makary, who is the director of the FDA, to do a complete review and to report back,” Kennedy added.
Kennedy’s comments are similar to those made last week by Jim O’Neill, President Donald Trump’s pick to serve as HHS Deputy Secretary. O’Neill promised Hawley he would have the FDA conduct an updated safety review of mifepristone following the EPPC’s bombshell study.
Formerly a pro-abortion Democrat, Kennedy has largely deferred to Trump’s abortion stances amid scrutiny from Republicans and Democrats alike on his ever-shifting positions. Makary faced similar scrutiny from Republicans and Democrats over mifepristone access during his confirmation hearing, as Republicans asked for promises to restrict access and Democrats pressed Makary on preserving current rules.
A pro-life advocate, Hawley introduced legislation last week to reinstate regulatory safeguards surrounding mifepristone and enable women who have been harmed by the drug to sue tele-health companies for mailing it illegally. He previously sent a letter to Makary urging him to restore the safety regulations and make him aware of the EPPC’s study.
Moreover, Hawley has urged the Trump administration to reconsider its defense of the Biden administration’s hands-off position on mifepristone in federal court. Missouri is leading the litigation against the Biden administration’s policy that allowed mifepristone to be delivered via mail with little medical supervision.
The EPPC study is based on an analysis of an insurance claims database that includes 865,727 records from 2017 to 2023. The think tank’s research concluded that 10.93 percent of women experience a serious adverse event within 45 days of a mifepristone abortion, a rate 22 times higher than the figures on the drug’s current label. EPPC’s data is based on a dataset of prescribed abortions 28 times larger than all the FDA-cited clinical trials put together.
In 2024, the pro-abortion Guttmacher Institute released data showing chemical abortions comprised 63 percent of all abortions in 2023, a ten percent increase over the past three years. The proliferation of medication abortions developed over the past half century since the FDA approved mifepristone in 2000 at the end of the Clinton administration. The next two Democratic presidents, Obama and Biden, both sought to expand access to the abortion drug, helping spur the increase in its usage.
President Trump previously said the FDA would not prevent access to the abortion pill under his administration, maintaining the distancing he took concerning abortion throughout the 2024 campaign, sometimes to the dismay of pro-lifers.
Last year, the Supreme Court threw out a case challenging the FDA’s approval of mifepristone on the grounds that the plaintiffs, a group of conservative doctors, lacked standing to sue the agency, a disappointment for pro-lifers.