Report: FDA Broke its Rules on Alzheimer's Drug

Image copyright: Reuters

The Facts

  • 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.

The Spin

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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