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Morning Briefing

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Monday, Apr 10 2023

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Mifepristone Ruling Could Impact FDA, Other Approved Drugs

News outlets report on the side effects of the controversial ruling. Some argue it could pose a threat to the regulatory power of the FDA, impacting more than this one medication. HHS Secretary Xavier Becerra voiced worries about implications for "every kind of drug."

A federal judge鈥檚 ruling to revoke the Food and Drug Administration鈥檚 longstanding approval of the abortion pill mifepristone poses threats to the U.S. government鈥檚 regulatory authority that could go far beyond one drug, legal experts say. The decision by a Texas judge appears to be the first time a court has moved toward ordering removal of an approved drug from the market over the objection of the F.D.A. (Jewett and Belluck, 4/10)

Last week鈥檚 dueling court rulings on abortion pills are refocusing attention on what legal powers the Food and Drug Administration has over prohibited drugs 鈥 and when it can disregard a prohibition. If a Texas federal judge's ruling stands, and the abortion drug mifepristone no longer has FDA approval, then manufacturing, selling and distributing it will be outlawed. But some legal experts say the agency has discretion to chart a path forward and keep some semblance of the status quo. (Bettelheim and Gonzalez, 4/10)

鈥淲hen you turn upside down the entire FDA approval process, you鈥檙e not talking about just mifepristone,鈥 Xavier Becerra said on CNN鈥檚 鈥淪tate of the Union鈥 on Sunday. 鈥淵ou鈥檙e talking about every kind of drug. You鈥檙e talking about our vaccines. You鈥檙e talking about insulin. You鈥檙e talking about the new Alzheimer鈥檚 drugs that may come on.鈥 (Neukam, 4/9)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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