A federal judge’s ruling to revoke the Food and Drug Administration’s longstanding approval of the abortion pill mifepristone poses threats to the U.S. government’s 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.
If the initial ruling, a preliminary injunction issued on Friday, withstood appeals, it could open the door to lawsuits to contest approvals or regulatory decisions related to other medications. And if upheld, the Texas decision would shake the very framework of the pharmaceutical industry’s reliance on the F.D.A.’s pathways for developing new drugs, legal experts said.
“This is a frontal assault on the legitimacy of the F.D.A. and their discretion to make science-based decisions and gold…