A Break-Even Year For US FDA Advisory Committees?
Meetings have continued to be sparse through 2021, but there will end up being nearly as many panels on withdrawing approved uses as on approving new ones.
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Chief scientist Denise Hinton will decide the fate of Covis’ preterm birth prevention drug because acting commissioner Janet Woodcock has recused herself; CBER deputy director Celia Witten is tapped to serve as presiding officer at the hearing, which will be only the second of its kind under accelerated approval regulations.
FDA’s external advisory committee process is under increasing scrutiny within the agency and by the public – and the agency is continuing to be very sparing in convening actual reviews.
CMS is famous for not being able to negotiate prices – and its payment for physician-administered drugs notoriously incentivizes higher prices. Yet, as the Biogen/Eisai Aduhelm experience shows, CMS can on occasion have a profound impact on product launches when it chooses to.