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Federal Judge Rules That FDA’s Mifepristone Restrictions Are Excessive, Unscientific and Unlawful
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TPM – Talking Points Memo
A federal judge in Virginia ruled in favor of an abortion provider Thursday, finding that the Food and Drug Administration’s most recent set of restrictions on mifepristone isn’t justified by the data.
Whole Woman’s Health, a reproductive health clinic in Alexandria, joined a rich history of medical organizations and providers challenging the Risk Evaluation and Mitigation Strategy (REMS), some form of which has been imposed on mifepristone for years.
Still, the drug is larded up with restrictions that Judge Robert Ballou, a Biden appointee, found to be unsupported by FDA’s review of the drug’s safety.
“Plaintiffs note that other commonly prescribed drugs, comparable in safety to mifepristone, have been approved without any REMS requirements,” Ballou wrote in Whole Woman’s Health Alliance v. FDA.
In Whole Woman’s Health, the clinic is trying to make mifepristone as accessible as possible in Virginia, one of the only southern states where abortion is still legal.