Physicians’ Favorable Views of FDA Drug Approval Standards Underscore ‘Disconnect,’ Survey Finds

Regulatory NewsRegulatory News | 23 January 2019 |  By 

A research letter published in JAMA Internal Medicine on Tuesday highlights the “disconnect” between many physicians’ perceptions of the US Food and Drug Administration (FDA) drug approval process and the “current reality.”

The findings are based on a survey aimed at gaging physicians’ attitudes toward FDA drug approval standards and off-label promotion, with a total of 686 survey (48% response rate) respondents listed by the American Board of Internal Medicine Diplomate.

On FDA’s new drug approvals, most respondents (80%) agreed that the agency’s approval process achieves the mission of protecting the public. More than half (65%) of respondents also reported being satisfied with FDA’s drug approval standards. The disconnect relates to most (78%) respondents citing a preference for drugs to be tested in two prospective randomized trials prior to the agency’s approval.

“FDA approves about one-third of new drugs on the basis of a single randomized trial and often relies on results from nonrandomized studies,” wrote lead author Aaron Kesselheim, Harvard Medical School associate professor and director of the Brigham and Women’s Hospital’s program on regulation, therapeutics and law.

On off-label promotion, most respondents (60%) supported current restrictions. Out of those that viewed such promotion as a “bad idea” or “terrible idea,” a total of 479 (71%) physicians pointed to promotion by sales representatives in physician offices, followed by 458 (68%) in medical journals.

The consensus among survey respondents that favored current restrictions on off-label promotion reportedly cited a potential increase in prescriptions for “diseases not previously considered medical problems" and “drugs without meaningful benefits,” as well as worsened clinical decisions.

The survey was prompted by “fundamental aspects” in FDA’s oversight of the pharmaceutical market that have “become controversial,” Kesselheim noted. The research letter points to increased use of expedited pathways and recent legislative actions that scaled back restrictions on off-label promotion of pharmaceuticals.

Physicians’ Perspectives on FDA Approval Standards and Off-Label Drug Marketing


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