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.

Endpoints News

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Venture & Research Associate

Alexandria Real Estate Equities

San Francisco, CA, USA