FDA commissioner Marty Makary to review safety of abortion drug mifepristone
In a letter to Sen. Josh Hawley, R-Mo., Makary revealed the FDA's plan on Monday to review the abortion pill after Hawley alerted the commissioner to the study.
"As the Commissioner of Food and Drugs, I am committed to conducting a review of mifepristone and working with the professional career scientists at the agency who review this data," Makary wrote.
"As with all drugs, FDA continues to closely monitor the postmarketing safety data on mifepristone for the medical termination of early pregnancy," Makary added.
Hawley referred the FDA commissioner to the recent study, from the Ethics and Public Policy Center, which found 11% of women experienced sepsis, infection or hemorrhaging within 45 days of taking the pill.
While Hawley said that information is listed as a side effect for mifepristone, the numbers are 22 times greater than the label warns. The study was based on insurance claims for 865,727 mifepristone abortions between 2017 and 2023.
"I'm calling on the FDA to reinstate safety regulations on the chemical abortion drug immediately. New data out today show a massive number of severe medical side effects," Hawley said in April. "The time to act is now."
Makary told senators during his confirmation hearing in March that he would oversee a review of mifepristone, but did not order it until Hawley alerted him to the EPPC study. The FDA commissioner did express concerns earlier this year about the Biden administration's policy, which allowed women to access abortion drugs without making in-person appointments.
Last year, the U.S. Supreme Court rejected a challenge to the FDA's approval of mifepristone, saying the pro-life doctors who brought the case lacked standing. The court said the Alliance for Hippocratic Medicine failed to prove they suffered any harm from the FDA's policies.
President Donald Trump, who supported the Supreme Court's decision, was also urged by Hawley to order a mifepristone review over the EPPC's findings.
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