April 18, 2016
1 min read

Physicians lack clarity on FDA approvals, ‘breakthrough therapy’

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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 FDA approval.”

The researchers surveyed a cohort of 1,148 physicians, contacted through the American Board of Internal Medicine’s diplomate list. The survey included three questions about FDA approval and five questions about breakthrough therapies. The researchers also included a hypothetical situation, in which physicians were asked to choose between prescribing two new drugs, one of which was labeled “breakthrough therapy,” while, in fact, both met the criteria for breakthrough therapies. Physicians also were randomly selected to give their opinions on one of four mock FDA press releases for a hypothetical drug.

Study results showed that 73% of respondents mistakenly believed that FDA approval meant that the drug’s effectiveness was comparable to that of other approved drugs, while 70% mistakenly believed that FDA approval required a statically significant and clinically important outcome. Likewise, 52% of respondents incorrectly believed that drugs labeled as breakthrough therapy required randomized trials to claim the designation.

Furthermore, 94% of respondents preferred the hypothetical drug that was labeled as a “breakthrough therapy” over the nonlabeled version.

“The misconceptions identified may lead physicians to overprescribe newly approved drugs — particularly breakthrough therapies — and inadequately communicate how well these drugs work to the patients who will use them,” Kesselheim and colleagues wrote. – by David Costill

Disclosure: Kesselheim reports no relevant financial disclosures. Please see the full study for a list of all other authors’ relevant financial disclosures.