Health and Human Services (HHS) Secretary Kennedy and Food and Drug Administration (FDA) Commissioner Martin Makary confirmed that FDA is conducting a safety review of mifepristone to determine whether to reinstate a medically unnecessary in-person dispensing requirement for the medication. In a letter sent to Republican Attorneys General, Kennedy and Makary confirmed that FDA is “conducting its own review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy of the drug.” The letter also cited a pseudo-study from the Ethics and Public Policy Center, a radical right-wing think tank, which used flawed methods to question mifepristone safety. 

FDA already continuously monitors the safety of approved drugs, and FDA has confirmed mifepristone’s safety and efficacy numerous times. More than 7.5 million women in the United States have used mifepristone safely, with adverse event rates the FDA itself characterizes as “extremely rare.”