Should the FDA Follow Advisory Committee Votes in Drug Approvals?

A recent survey requested feedback from advisory committee members. Most respondents thought that a thumbs down from committee members should lead to the Food and Drug Administration (FDA) denying the drug. The FDA disagrees.

“Nearly two-thirds of surveyed FDA AdComm members believe there should be a threshold where an advisory committee vote is “so strongly against approval that the FDA should no longer consider approval for the product based on the currently available data.”Given that first statistic, it shouldn’t be surprising that the respondents disagreed with the FDA’s approval of Aduhelm by a 4:1 margin.” Read more here.

(Source: Derrick Gingery, Pink Sheet, 8/17/21)