HHS ex­tends Aduhelm in­ves­ti­ga­tion in­to the ac­cel­er­at­ed ap­proval path­way, wad­ing in­to a brew­ing con­tro­ver­sy

The gov­ern­ment in­ves­ti­ga­tion in­to how the FDA ap­proved Aduhelm ap­pears to point well be­yond the agency’s ties with Bio­gen in the lead­up to its ap­proval of their con­tro­ver­sial Alzheimer’s drug Aduhelm.

The HHS Of­fice of In­spec­tor Gen­er­al post­ed a no­tice Wednes­day that of­fi­cials will re­view the ac­cel­er­at­ed ap­proval path­way, the reg­u­la­to­ry mech­a­nism the agency used to ap­prove the drug in the face of con­flict­ing da­ta over whether it could ac­tu­al­ly slow Alzheimer’s pa­tients’ men­tal de­cline. Now the Aduhelm OK is just one branch of an in­ves­ti­ga­tion called for last month by act­ing FDA com­mis­sion­er Janet Wood­cock.

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