Scott Got­tlieb crit­i­cizes CMS in feud over Aduhelm cov­er­age, calls out their lack of ex­per­tise

For­mer FDA com­mis­sion­er and cur­rent Pfiz­er board mem­ber Scott Got­tlieb went on the of­fen­sive against CMS this morn­ing — cit­ing the agency’s “flawed de­ci­sion mak­ing” and how the agency’s de­ci­sion on Aduhelm is putting not just Alzheimer’s drug re­search in lim­bo but po­ten­tial­ly set­ting a neg­a­tive prece­dent for ac­cel­er­at­ed ap­provals.

Got­tlieb, who was in charge of the fed­er­al agency from 2017-2019, talked with Bio­Cen­tu­ry’s Steve Us­din on how the prece­dent that CMS is set­ting could im­pact ac­cel­er­at­ed ap­provals out­side of Alzheimer’s — and even fur­ther, blur­ring the lines of au­thor­i­ty be­tween the FDA and CMS.

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