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Review of abortion pill safety is ongoing, Health and Human Services Secretary Kennedy says

Review of abortion pill safety is ongoing, Health and Human Services Secretary Kennedy says

Thursday, September 4, 2025
Health and Human Services Secretary Robert F. Kennedy Jr. said in a Senate hearing on Sept. 4, 2025, that the FDA review of abortion pill safety concerns is ongoing. / Credit: Carl DMaster/Shutterstock Washington, D.C. Newsroom, Sep 4, 2025 / 17:02 pm (CNA). Secretary Robert F. Kennedy Jr. of the U.S. Department of Health and Human Services (HHS) testified during a Senate hearing on Sept. 4 that a federal review of the safety concerns related to the abortion pill is still ongoing.Kennedy told the Senate Finance Committee that former President Joe Biden’s administration “twisted the data” to downplay health concerns about the abortion pill mifepristone.“We’re going to make sure that doesn’t happen anymore,” Kennedy said. “We’re producing honest science and gold-standard science on that.”Republican Sens. James Lankford and Steve Daines both pressed Kennedy on their concerns about the drug during the Thursday hearing.Kennedy was unable to say when the review would be completed or whether HHS or the Food and Drug Administration (FDA) would move toward regulating mifepristone more strictly. However, he committed to keeping the senators up to date on any developments. The FDA is “getting data in all the time — new data that we’re reviewing,” he said.Daines, the founder of the Senate Pro-Life Caucus, referenced a study by the Ethics and Public Policy Center (EPPC) that found that 11% of women who take the abortion pill suffer at least one “serious adverse event” within 45 days. The study reviewed the insurance claims of 865,727 women who used the drug to calculate that number.“That is 22 times higher than the FDA’s long-standing estimate of less than 0.5%,” Daines told Kennedy. “... For years we’ve heard the misleading and frankly very harmful lie that’s being sold to women that this drug is ‘as safe as Tylenol.’ These lies sadly have real-world consequences.”Both Daines and Lankford expressed concern about the deregulation of mifepristone under both the Biden and Obama administrations.The FDA reduced the number of in-person doctor visits required to obtain mifepristone from three to one in 2016 and then to zero in 2023. Another 2016 change ended requirements that mifepristone be dispensed by a physician, taken in a doctor’s office, and monitored in a follow-up visit. Another 2023 change permitted mail delivery of the drugs.Daines said the FDA “has steadily stripped away safeguards related to this drug” and asked Kennedy whether the Trump administration would reverse the Biden administration’s deregulation.Kennedy told Daines he needs to check with the White House to know its position on that and would “need to get back to you on that” by next week.In December 2024, Trump told Time magazine that he was committed to ensuring the abortion pill remains legally available. However, he also directed Kennedy to facilitate studies on the safety of the drug.“Those studies are progressing and … they’re ongoing,” Kennedy said in the hearing.Marjorie Dannenfelser, the president of Susan B. Anthony Pro-Life America, in a statement published after the hearing thanked the senators for raising those concerns and thanked Kennedy and the administration for reviewing safety concerns about the drug.“We are grateful that Secretary Kennedy confirmed the FDA’s review of abortion drugs is now underway and look forward to his promised release of new data after years of the Biden administration ignoring this urgent issue,” she said. “Secretary Kennedy even revealed that Biden’s FDA ‘twisted’ data to bury safety signals.”Dannenfelser warned that “as women and children are harmed, these dangerous drugs continue to be bought and sold with no commonsense safeguards and no accountability.”“We look forward to hearing the update on restoring the in-person dispensing of mifepristone,” she said.More than half of all abortions nationwide are now conducted chemically with pills, including mifepristone.The FDA approved mifepristone in 2000 to complete abortions through the first seven weeks of pregnancy. In 2016, the FDA expanded its approval to the first 10 weeks of pregnancy.At 10 weeks of pregnancy, an unborn child has a fetal heartbeat, early brain activity, and partially developed eyes, lips, and nostrils. Mifepristone blocks the hormone progesterone, which cuts off the child’s supply of oxygen and nutrients to kill the unborn child. A second pill, misoprostol, helps expel the body from the mother by essentially inducing labor.