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.
The authors also explain how this decade-long decrease in FDA’s referrals of investigational drugs to advisory committees suggests that the “FDA needs specific criteria for how it chooses to subject new drugs to external scrutiny. Publishing referral criteria would improve accountability by allowing the public to compare the FDA’s referral decisions in individual cases against preexisting standards.”
Meanwhile, as FDA commissioner Rob Califf has announced recently that he plans to tweak the adcomm process, the authors also suggest that the FDA should provide a formal statement when it runs counter to an adcomm’s recommendation (which it does about once annually). The researchers said they found only one exception where the FDA explained itself: After Biogen’s controversial Alzheimer’s drug’s accelerated approval, the FDA released a statement recognizing that fact and somewhat explaining its decision.
“In instances when the FDA chooses to act against advisory committee recommendations, it could make a practice of engaging in a thorough and transparent accounting of the disagreement through preestablished procedures,” the authors wrote. “The ‘response and rebuttal’ portion of aducanumab’s medical review offers a prototype for a transparent, meaningful, and consistent discussion over whether to allow a new drug to market. Robust engagement with the merits of a discordant recommendation, such as when an agency responds to public comment in the rulemaking process, would indicate that the FDA has responsibly considered the advice of the experts it convened.”
Inconsistency in the sometimes leading questions posed to the committee and the FDA’s response to a negative vote (typically dependent on the gap between the number of ‘yes’ and ‘no’ votes) invites scrutiny into the role of advisory committees in the FDA’s decision-making process.
Such scrutiny comes as Harvard’s Aaron Kesselheim, one of the authors of the Health Affairs article, resigned from the adcomm that voted against Aduhelm, immediately following the agency’s approval.