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.