Kyle Faget Comments on FDA's Generic Mifepristone Approval
Foley & Lardner LLP partner Kyle Faget commented in the InsideHealthPolicy article, “Experts: Generic Mifepristone Approval Separate From FDA Study Of Telehealth Rx,” sharing legal insight on the possible implications for telehealth companies.
Faget, commenting on the U.S. Food and Drug Administration’s approval of a new generic version of mifepristone, said that a wholesale removal of mifepristone from the market is unlikely and that the FDA’s recent approval does not interfere with updates underway to the drug’s in-person prescribing requirements.
“If the [risk evaluation and mitigation strategy (REMS) for mifepristone] is reinstated, then that’s a win for conservatives on this point, and the biggest reason why it’s a win is there’s implications for telemedicine,” she added. “If the REMS is rolled back and mifepristone can only be dispensed in-person by a provider, the telemedicine issue kind of goes away.”
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