HHS Secretary Robert F. Kennedy Jr. asks FDA for ‘complete review’ of abortion pill risks

Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced Wednesday that he believes the Food and Drug Administration (FDA) should conduct a “complete review” of the abortion pill. The announcement comes after a recent analysis of insurance data published by the Ethics and Public Policy Center (EPPC) stated that “serious adverse events” (complications) of the abortion pill (mifepristone) occur at a rate far higher than the rate reported on the FDA’s drug label.

As reported by Live Action News:

[According to the EPPC,] nearly 11% of women (10.93%) experience sepsis, infection, hemorrhaging, or other serious or life-threatening adverse events following a mifepristone abortion. This means one in ten women experience at least one serious complication from taking mifepristone within 45 days — 22 times higher than the “less than 0.5 percent” serious adverse events rate reported by the FDA on the mifepristone label, according to this study.

The study authors state that serious adverse events in multiple categories were accounted for in the reported rate.

Research from the EPPC also claims that the failure rate of mifepristone is nearly double the failure rate currently listed on the FDA-approved drug label. Though the FDA label asserts a 2.6-3.8% failure rate for mifepristone abortions, the EPPC’s analysis states that real-world data shows a failure rate of 5.26.

Kennedy’s comments came during a Senate Health, Education, Labor, and Pensions Committee hearing, when Senator Josh Hawley referenced the EPPC report and asked Kennedy if he would look into the study’s findings.

Emily Kopp

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RFK Jr. says he has asked FDA to do a thorough review of mifepristone in light of a study indicating serious side effects could be 22x more common than the FDA says

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7:44 PM · May 14, 2025

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“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.

“It’s alarming,” Kennedy said of the EPPC data, adding, “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 said he did not have a sense of a timeline of when such a review would take place.

Last week, Hawley introduced legislation that would reinstate safety regulations surrounding the distribution of mifepristone while limiting the importation of the abortion pill and allow women harmed by the abortion pill to sue for damages. In a press release, Hawley referenced the EPPC report as reason why the FDA should restore the safeguards previously placed around the abortion pill.

“I’m introducing the Restoring Safeguards for Dangerous Abortion Drugs Act after a bombshell study revealed the truth about mifepristone: it’s dangerous,” he said. “The data shows 1 in 10 women who take mifepristone experience adverse health effects, like going to the ER or suffering from sepsis. The FDA needs to act to protect women now.”