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Although advisory committee members and FDA agency members may be broadly aligned in their goals, issues like the agency’s concerns about its reputation may result in different patterns of decision making. For example, the FDA has an incentive to avoid reversing earlier decisions insofar as those reversals might damage its credibility.

That would explain why regulators are more inclined to maintain an existing product’s availability by taking a less restrictive stance on safety issues, while drawing a firmer line over novel products and new indications.

The findings are in line with literature cited in the paper, which the researchers — Audrey Zhang New York University together with Jason Schwartz and Joseph Ross at Yale — say are less comprehensive but suggest that regulators agree with adcomms 60% to 87% of the time.

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