No Vote, No Mandate? FDA Opioid Meeting Shows Limits Of Non-Voting Panels

US FDA Commissioner Califf has proposed that the agency move away from ‘gladiator votes’ that frame advisory committee meetings as a yes-or-no decision on a single question and instead emphasize the importance of the expert discussion and nuance of regulatory issues. The latest high-profile advisory committee review of a key opioid response issue shows the challenges with that approach.

FDA no voting
Is this the best direction for FDA? • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock images

US Food & Drug Administration officials routinely emphasize one key point in framing the questions they pose to their expert advisory committees: the agency values the discussion of the issues by the invited experts much more than the final count on any vote they may take.

Commissioner Robert Califf has urged that the agency apply that philosophy more directly, by holding more meetings that do

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