FDA over­rides ad­comm opin­ions a fifth of the time, study finds — but why?

For drug­mak­ers, FDA ad­vi­so­ry pan­els are of­ten an ap­pre­hend­ed barom­e­ter of reg­u­la­tors’ fi­nal de­ci­sions. While the ex­perts’ en­dorse­ment or crit­i­cism of­ten trans­late di­rect­ly to fi­nal out­comes, the FDA some­times stun ob­servers by di­verg­ing from rec­om­men­da­tions.

A new pa­per out of Mil­bank Quar­ter­ly put a num­ber on that trend by an­a­lyz­ing 376 vot­ing meet­ings and sub­se­quent ac­tions from 2008 through 2015, con­firm­ing the gen­er­al im­pres­sion that reg­u­la­tors tend to agree with the ad­comms most of the time — with dis­cor­dances in on­ly 22% of the cas­es.

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