Gottlieb stirs debate over CMS Aduhelm decision

Former FDA Commissioner Scott Gottlieb’s comments on The BioCentury Show about the policy implications of CMS’ draft coverage decision for Aduhelm and future Alzheimer’s mAbs have elicited sharp responses, including rebukes from a former CMS official and prominent academics.

The exchanges are part of a larger, ongoing debate over the merits of the CMS draft coverage decision, FDA’s accelerated approval of Aduhelm aducanumab-avwa from Biogen Inc. (NASDAQ:BIIB), and the pricing of drugs marketed under an accelerated approval. ...