STAT+: Pharmalittle: Abortion pill ruling could threaten FDA approval authority; Lilly CEO warns EU pharma legislation will hurt innovation
A federal judge's ruling to revoke longstanding FDA approval of the abortion pill mifepristone threatens U.S. government regulatory authority.
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The ruling by a U.S. federal judge to revoke longstanding U.S. Food and Drug Administration approval of the abortion pill mifepristone poses threats to U.S. government regulatory authority that could go far beyond one drug, The New York Times explains. 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. The initial ruling could open the door to lawsuits to contest approvals or regulatory decisions related to other medications. If upheld, the decision would shake the very framework of the pharmaceutical industry’s reliance on the FDA pathways for developing new drugs.
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