Accusing an entire organization like the FDA (U.S.

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Accusing an entire organization like the FDA (U.S. Food and Drug Administration) of being corrupt is a serious allegation that should be supported by substantial evidence.

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What a congressional investigation reveals about FDA's approval of Aduhelm

In its investigation, the committees found that FDA's approval of Aduhelm was "rife with irregularities" and "raise serious concerns about [the agency's] lapses in protocol."

Between July 2019 and July 2020, FDA and Biogen created a "working group" to analyze Aduhelm's clinical trials, engaging in at least 115 meetings, calls, and email exchanges—interactions that the report called "atypical." The committees also found that at least 66 calls and email exchanges were not properly documented.

The report also highlighted concerns with Aduhelm's accelerated approval status, which it "abruptly" gained after "unfavorable feedback" from an advisory committee through the traditional approval process. Granting Aduhelm accelerated approval was also against FDA's guidance for Alzheimer's drugs, which stated the disease had not yet met "the standard for accelerated approval."

In addition, FDA initially recommended Aduhelm for all patients with Alzheimer's, despite the drug only being tested in patients with early-stage disease. In fact, Biogen's advisors warned against a broad label for the drug, saying that it could lead to safety risks and other issues. However, it was only after public pushback and confusion that Biogen asked for Aduhelm's label to be narrowed.
https://www.advisory.com/daily-briefing/2023/...estigation

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