Denise Esposito's commentary was included in a Bloomberg Law article about the U.S. Court of Appeals for the Fifth Circuit's decision that partially granted the Biden administration’s request for an emergency stay on a Texas federal judge’s mifepristone suspension.
The Fifth Circuit opinion “creates untenable ambiguity about which products will be available and what restrictions will apply,” said Denise.
"Meanwhile, because health-care providers generally are not regulated by the FDA, they could remain free to prescribe the drug in some states," Denise believed.
“I would argue that it is not a violation of the Federal Food, Drug and Cosmetic Act for a health-care provider to prescribe or administer a drug that is already on the shelves after an approval is suspended. The practice of medicine is generally regulated at the state level,” added Denise.
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