New Alzheimer's drug ap­proval fall­out: Pub­lic Cit­i­zen seeks re­moval of FDA's Wood­cock, Cavaz­zoni and Dunn

As Capi­tol Hill be­gins to wake up to the fi­nan­cial and sci­en­tif­ic mess be­hind the FDA’s ap­proval of Bio­gen’s new con­tro­ver­sial Alzheimer’s drug Aduhelm, non­prof­it watch­dog Pub­lic Cit­i­zen is now call­ing for the top three FDA of­fi­cials who are re­spon­si­ble to be re­moved from their po­si­tions.

In a let­ter to HHS Sec­re­tary Xavier Be­cer­ra on Wednes­day, the group high­light­ed the “litany of flaws” in the FDA’s ap­proval of the new drug, in­clud­ing the “un­prece­dent­ed, in­ap­pro­pri­ate­ly close” col­lab­o­ra­tion be­tween the FDA and Bio­gen in the analy­sis of key tri­al da­ta, bas­ing ap­proval on an un­val­i­dat­ed sur­ro­gate end­point, not fol­low­ing the ad­vice of its ex­pert ad­vi­so­ry com­mit­tee (3 mem­bers of which have since re­signed), and the wide la­bel that the agency grant­ed.

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