Health Secretary Robert F. Kennedy Jr. has launched an FDA review of mifepristone, the drug used in two-thirds of all abortions. Advocates warn that restrictions could limit access even in states where abortion remains legal, sparking debate over reproductive rights.

Washington

The U.S. Food and Drug Administration has initiated a review of mifepristone, a drug used in the majority of abortions in the United States. Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Macri announced the review, citing a report from a conservative think tank that questions the drug's safety, despite longstanding approval and support from leading medical organizations.

Medical experts, including Dr. Celine Gounder, emphasize that mifepristone has been deemed safe and effective by major medical groups, with serious complications being rare. The review could potentially lead to new restrictions on access to the drug, such as limiting telehealth use or restricting pharmacy distribution, though a full ban would likely face significant legal challenges.

FDA begins review of mifepristone, abortion access at stake

CBS News has confirmed that Health Secretary Robert F. Kennedy Jr. has launched an FDA review of Mifeprestone, the drug used in two-thirds of all abortions. Abortion rights advocates are worried the FDA could restrict access to the pill even in states where abortion is legal. CBS News medical contributor Dr. Celine Gounder joins us now to explain. So, Celine, what do we know about this drug and why is Kennedy asking the FDA to scrutinize it? Mifeprestone has been FDA approved since 2000, and the nation's leading medical groups, which include the American College of Physicians and the Society for Maternal Fetal Medicine, both say that Mifeprestone is safe and effective, with serious complications being exceedingly rare. So why is HHS scrutinizing Mifeprestone now? Well, honestly, it's not complicated. It's because Mifeprestone is used for abortion. The best medical evidence right now continues to show Mifeprestone is safe and effective. Now, a letter signed by Secretary Kennedy and FDA Commissioner Marty Macri said, quote, HHS, through the FDA, is conducting its own review of the evidence, including real-world outcomes and evidence relating to the safety and efficacy of the drug. And they are relying on a report that was released by the conservative think tank, the Ethics and Public Policy Center, to reopen questions about the safety of Mifeprestone. That report claims that roughly one in 10 women who receive Mifeprestone have a serious complication. Other data sources show the rate of serious complications to be much lower, at less than one in 200. So could you see this leading to a ban on Mifeprestone? Well, Maurice, the FDA would have to withdraw approval, an extraordinary step that would face immediate legal challenges. More likely, if the review is used to change policy, it would be to make it much harder to access Mifeprestone, like limiting telehealth, requiring prescription by a doctor, not other health care providers, and restricting pharmacy dispensing or mailing of Mifeprestone.

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