by Emmitt Barry, Worthy News Correspondent
(Worthy News) – U.S. Health Secretary Robert F. Kennedy Jr. announced on May 14 that he has directed the Food and Drug Administration (FDA) to conduct a comprehensive review of the abortion pill mifepristone, citing newly surfaced data indicating a significantly higher rate of serious adverse events than previously reported.
“I think the new data … is alarming, and clearly it indicates that at the very least, the label should be changed,” Kennedy said during a Senate hearing.
His comments came in response to a question from Sen. Josh Hawley (R-Mo.), who referenced a recent analysis of insurance claims suggesting that approximately 11 percent of women who took mifepristone experienced serious complications. That figure contrasts sharply with the FDA’s official data, which reports a serious adverse event rate of under 0.5 percent based on clinical trials.
Kennedy said he has instructed FDA Commissioner Dr. Marty Makary to complete a full review of the findings and report back with recommendations. Hawley later celebrated the move on the social media platform X, writing, “RFK Jr. just pledged to conduct a top-to-bottom review of the drug–and said the FDA label needs to change. A win for life.”
While mifepristone has been marketed as safe when used according to guidelines, the new data–published by the Ethics and Public Policy Center, a Washington, D.C.-based think tank–has prompted renewed scrutiny. The center has not disclosed the source of its data, but maintains the analysis exposes significant safety concerns.
Makary, who assumed leadership of the FDA earlier this year, said during his March confirmation hearing that he had no plans to alter mifepristone policy without compelling evidence. However, at an April summit, he acknowledged that ongoing data collection could change that.
“There is an ongoing set of data that is coming into FDA on mifepristone,” he said. “So if the data suggests something or tells us that there’s a real signal, we can’t promise we’re not going to act on that data.”
Mifepristone has been at the center of political and legal battles in recent years. Under the Biden administration, the FDA removed several restrictions on its distribution, including the requirement that it be dispensed in person. Some lawmakers, such as Sen. Bill Cassidy (R-La.), have urged the agency to reinstate those limitations.
When asked about restoring the in-person dispensing rule, Kennedy said the final policy would be shaped by recommendations from Makary and ultimately decided by President Donald Trump.
“I feel that the policy changes will ultimately go through the White House, through President Trump,” Kennedy said.
Kennedy also revealed during his confirmation process that Trump had asked him to evaluate the safety of mifepristone but has not yet issued specific directives.
Critics swiftly condemned Kennedy’s comments. The Center for Reproductive Rights stated on X, “President Trump … should not be making decisions about our healthcare, and RFK Jr. should not be interfering with our ability to access medication that’s been proven safe and effective.”
The FDA’s current label states that mifepristone has a high efficacy rate–terminating pregnancies in approximately 96 percent of cases without the need for further intervention–and a low rate of serious side effects such as sepsis.
Whether the new analysis will lead to regulatory changes remains to be seen, but the review ordered by RFK Jr. marks a significant shift in the federal approach to abortion pill oversight.
Copyright 1999-2025 Worthy News. This article was originally published on Worthy News and was reproduced with permission.
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