Posted by Michael Wonder on 29 Dec 2022
Congressional report: US FDA broke own protocols in approving Biogen Alzheimer's drug
29 December 2022 - The US FDA failed to adhere to its own guidance and internal practices during the approval process for Biogen's Alzheimer's drug Aduhelm, which was "rife with irregularities," a congressional report showed on Thursday.
The FDA's interactions with Biogen were "atypical" and did not follow the agency's documentation protocol, according to a staff report on the findings of an 18 month investigation conducted by two House of Representatives committees into the drug's regulatory review, approval, pricing, and marketing.
