The FDA's approval process of Biogen's Alzheimer's drug was questioned in a Congressional report released Thursday.
A report by two House committees questioned the approval process for an Alzheimer’s drug produced by Biogen.process "rife with irregularities."
The drug in question is Aduhelm, which was approved for use in 2021 even though research studies failed to prove it really helped patients. The 18-month investigation detailed "atypical collaboration" between FDA regulators and a company it’s supposed to oversee.The probe also cited saying the company intended to "make history" when it set what investigators called an "unjustifiably high" initial price of $56,000 a year for the drug.Thursday’s report urged the agency to "take swift action" to ensure that any future Alzheimer's approvals aren’t met with "the same doubts about the integrity of FDA’s review."In a statement Thursday, the FDA said the Aduhelm decision "was based on our scientific evaluation of the data.
Thursday’s report said FDA and Biogen engaged in an unusually high volume of phone calls, meetings and emails, some of them not properly documented.Biogen said: "Alzheimer’s is a highly complex disease and we have learned from the development and launch of Aduhelm" but that it "stands by the integrity of the actions we have taken.
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