Where did all the FDA adcomms go? New research digs into steep drop in meetings
About a decade ago, half of all newly approved drugs were brought before an FDA advisory committee, which is made up of a group of outside experts who take a thorough look at the data presented by both the drugmaker and the FDA.
For myriad reasons, however, that figure has dropped dramatically and now just 6% of all new approvals were brought before an adcomm in 2021.
“It’s hard to say why fewer new drugs are seeing advisory committee review before approval, because FDA doesn’t have to explain that decision. One concern is that FDA might be trying to avoid the risk of a negative vote, if it’s shepherding a drug to approval,” Harvard’s Joseph Daval, first author of the new paper in Health Affairs told Endpoints News.
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