As the Food and Drug Administration grapples with rising pressure to approve new medicines more quickly, a new analysis finds the agency disagreed with its expert advisory panels about one-fifth of the time. And the disagreements were more likely to occur over safety issues than over approving new products or additional uses for existing products.
Of those disagreements, 75% resulted in the FDA making more restrictive decisions after an advisory panel made a favorable recommendation, while 25% resulted in the agency making less restrictive decisions after unfavorable panel recommendations, according to the analysis, which was published in The Milbank Quarterly and reviewed 376 panel meetings that took place between 2008 and 2015.
Interestingly, the authors also found that disagreement was not more common when panel members had conflicts of interest, when there was more media coverage or more public speakers at an advisory panel meeting, or when the products were being reviewed as special regulatory programs, such as efforts to endorse a drug in order to satisfy an unmet medical need.
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