Physicians lack clarity on FDA approvals, ‘breakthrough therapy’

Physicians demonstrated limited understanding of the FDA approval process and the meaning of the “breakthrough therapy” designation, according to recent research in JAMA.“Although the term ‘breakthrough’ leads consumers to overly optimistic beliefs about drug effectiveness, it is not known how physicians understand this term — or more generally, what FDA approval means,” Aaron S. Kesselheim, MD, JD, MPH, of the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital, and colleagues wrote. “A national survey of board-certified internists and specialists revealed substantial deficits in knowledge of the meaning of (Read more...)

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