CNA Staff, May 15, 2025 /
16:33 pm
The U.S. Food and Drug Administration (FDA) is reviewing the regulation and labeling of the abortion pill mifepristone following new evidence of safety concerns regarding its current use, U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. said on Wednesday.
More than 1 in 10 women who take the abortion pill mifepristone to complete a chemical abortion will suffer a serious health complication within 45 days of taking the drug, a recent study by the Ethics and Public Policy Center found.
The study also found that the rate of serious adverse side effects occurs at 22 times the rate that the FDA-approved drug label currently indicates.
“It’s alarming, and clearly it indicates that, at very least, the label should be changed,” Kennedy said when asked about the study by Sen. Josh Hawley, R-Missouri, during a Senate Health, Education, Labor, and Pensions Committee hearing.
During the hearing, Kennedy said that he has asked FDA director Marty Makary to “do a complete review and report back.” The FDA is an agency within the Department of Health and Human Services.
On Wednesday, a coalition of more than 100 organizations called for a review and restoration of previous federal safety regulations for the abortion drug in light of the study.
The open letter noted that under the Obama and Biden administrations, the FDA had removed various safety requirements including requirements for in-person prescriptions, provider follow-ups, and a doctor to be involved at any stage of the chemical abortion process.
“The evidence strongly suggests that mifepristone is unacceptably dangerous, and those who removed such protections put American women directly in harm’s way,” read the letter, which was signed by groups such as Americans United for Life, the Ethics and Public Policy Center, the American Association of Pro-Life OBGYNs, and dozens of other groups.
Various Catholic organizations are among the letter’s signatories, including the Catholic conferences of Colorado and Oklahoma.
“We encourage the administration and FDA to put the safety of women first and take a serious look at the data showing chemical abortion is neither safe nor effective,” the letter stated.
American Civil Liberties Union’s Julia Kaye, senior staff attorney for the Reproductive Freedom Project, criticized Kennedy’s decision to review the pill.
“If the FDA moves forward with this politically motivated review, that is a dangerous sign that the president is going back on his promises to voters not to restrict abortion access even further,” Kaye said in a statement.
In an interview last December, President Donald Trump promised that he would not ban the abortion pill but did not rule out regulating the drugs. Earlier this year, Kennedy said he planned to investigate safety concerns related to mifepristone.
Last week, Trump’s nominee for deputy secretary of the HHS, Jim O’Neill, also pledged to conduct a review of the safety of mifepristone in light of the EPPC’s study.
Chemical abortions make up 63% of abortions in the U.S., according to data from the Guttmacher Institute.
According to the EPPC, its study is the most comprehensive research on the abortion pill to date and is based on an insurance claims dataset that is 28 times larger than all the FDA-cited clinical trials.
(Story continues below)
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Kate Quiñones is a staff writer for Catholic News Agency and a fellow of the College Fix. She has been published by the Wall Street Journal, the Denver Catholic Register, and CatholicVote, and she graduated from Hillsdale College. She lives in Colorado with her husband.
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