New FDA doc­u­ments show in­ter­nal dis­sent on Aduhelm ap­proval

In a lengthy re­view doc­u­ment and a pair of mem­os from top of­fi­cials, the FDA re­leased on Tues­day night its most de­tailed ar­gu­ment yet for ap­prov­ing Bio­gen’s in­tense­ly con­tro­ver­sial Alzheimer’s drug ad­u­canum­ab.

The doc­u­ments amount to an agency at­tempt to quench the firestorm their de­ci­sion kin­dled, as out­side ad­vi­sors mem­bers re­signed and ex­perts warned that an un­proven drug now could stretch Medicare’s bud­get to a break­ing point. Ul­ti­mate­ly, the doc­u­ments show how CDER di­rec­tor Pa­trizia Cavaz­zoni and Of­fice of New Drugs di­rec­tor Pe­ter Stein both con­curred with FDA neu­ro­science head Bil­ly Dunn on the ac­cel­er­at­ed ap­proval while the staff at FDA’s Of­fice of Bio­sta­tis­tics did not think an ap­proval was war­rant­ed.

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