Report: FDA Broke its Rules on Alzheimer's Drug

    Report: FDA Broke its Rules on Alzheimer's Drug
    Last updated Dec 30, 2022
    Image credit: Reuters


    • According to a Thursday report by the US House Committee on Oversight and Reform and House Committee on Energy and Commerce, the US Food and Drug Admin.'s (FDA) approval process for Biogen's Alzheimer's drug Aduhelm was "rife with irregularities," and its interactions with the company were "atypical."
    • The investigation followed the FDA's decision to approve the drug in 2021 despite objections from its panel of outside advisors, who believed the data didn't prove benefits for patients. It was authorized on evidence that it could reduce brain plaques — a likely contributor to the disease — rather than its ability to slow the progression of Alzheimer's.
    • After the entire advisory panel voted not to approve Aduhelm, the FDA decided to switch from the traditional approval process and approve the drug through the accelerated process typically used for rare diseases or those with small patient pools.
    • The report adds that after an independent report showed the drug's inability to slow cognitive and functional impairment, Cambridge, Mass.-based Biogen canceled its clinical trials in March 2019. The FDA still approved it, along with its price of $56k per year.
    • Other irregularities claimed in the report include that FDA staff and Biogen held at least 115 meetings, calls, and email exchanges over 12 months beginning in July 2019, though the agency didn't keep a clear record of the interactions. The report claims 66 calls and emails weren't recorded.
    • Both Biogen and the FDA have stated they believe their interactions were "appropriate," though the agency has already begun implementing some of the report's recommendations. These include ensuring all interactions with drug companies are recorded and updating the industry guidance for developing and reviewing Alzheimer's drugs.


    Pro-establishment narrative

    While rare, this isn't the first time the FDA has deviated from its advisory committee's recommendation. The FDA, understanding the public attention this drug approval would get, has rightly stood by its reasoning, including the life-threatening nature of Alzheimer's, its unmet need for treatment, and the evidence that the drug reduces brain plaques. As with all approved drugs, the FDA has closely monitored its success as it entered the market.

    Establishment-critical narrative

    This report is not surprising in the slightest, as the FDA has been engaged in blatant drug approval corruption for a long time. While this may not be widely known, large pharmaceutical companies literally fund the FDA's drug review studies in what's known as its "user fee" program, leading to a never-ending cycle of regulatory capture.

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