Why does the FDA se­lect cer­tain drugs for ad­comm meet­ings? Re­searchers want to know

Al­though their num­bers have dwin­dled in re­cent years, FDA ad­vi­so­ry com­mit­tees have been in the spot­light, and some ex­perts are now seek­ing re­forms to make them more use­ful, in­clud­ing a trio of lead­ers from Har­vard’s Pro­gram on Reg­u­la­tion, Ther­a­peu­tics, and Law writ­ing in the New Eng­land Jour­nal of Med­i­cine.

The per­spec­tive ex­plains the way in which the FDA typ­i­cal­ly fol­lows the guid­ance from its ad­comm, al­though about once an­nu­al­ly, it doesn’t, and those missed con­nec­tions can lead to ma­jor blun­ders, as in the case of Bio­gen’s new Alzheimer’s drug ad­u­canum­ab, which won ap­proval via the ac­cel­er­at­ed path­way af­ter no ad­comm mem­bers vot­ed in fa­vor of its full ap­proval, but then failed to ob­tain cov­er­age from CMS, which re­quest­ed ad­di­tion­al ran­dom­ized tri­als.

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