A report by two House committees found that the Food and Drug Administration's controversial approval of the Alzheimer's drug Aduhelm was 'rife with irregularities.'
Even after a key FDA advisory committee's lack of recommendation for approval, the agency granted that approval to Aduhelm on June 7, 2021, based on the drug's effect on a proxy for clinical benefit – after which, several members of the committee publicly resigned in protest and the FDA's then acting-chief called for an internal investigation.
Furthermore, the report said that Biogen had initially set an "unjustifiably" high price of $56,000 per year for Aduhelm to "make history" for the company, that it was aware of the financial burden to Medicare and how costly it would be to patients, and that Biogen planned to spend more than $3.3 billion on sales and marketing for the drug from 2020 to 2024.
This criticism comes as the FDA is expected to decide whether to approve another new Alzheimer's drug next month.The report urged the agency to "take swift action" to ensure that any future Alzheimer’s approvals are not 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" and that the agency’s own internal review found its interactions with Biogen were appropriate. However, it said it plans to update guidance on Alzheimer’s drug development and will review the investigation’s findings.
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