A House investigation has concluded that the Food and Drug Administration (FDA) “collaborated” with biotechnology company Biogen on the approval of its Alzheimer’s drug Aduhelm. Indeed, as 2022 comes to a close, American taxpayers are reminded yet again of the inappropriate and dishonest manner in which the FDA—the agency funded by taxpayers to ensure the safety and efficacy of the medications they take—collaborates with Big Pharma.
Eighteen months in the making, the just-released report titled “The High Price of Aduhelm’s Approval: An Investigation into FDA’s Atypical Review Process and Biogen’s Aggressive Launch Plans” found that the FDA’s approval process was “rife with irregularities.” The two House of Representatives committees—Oversight and Reform and Energy and Commerce—investigated the drug’s regulatory review, approval, pricing, and marketing. The report points to “collaboration” between Biogen and the FDA ahead of an advisory committee meeting that nevertheless resulted in none of the eleven panelists voting in favor of approval for Aduhelm (aducanumab).
Specifically, the FDA’s Peripheral and Central Nervous Systems Drugs Advisory Committee (PCNS Advisory Committee) overwhelmingly disagreed that the data proved the drug’s benefits to patients. The report notes the Committee members “did not agree that it was reasonable to consider the clinical benefit of the one successful trial as the primary evidence supporting approval.” Regardless, the FDA approved Aduhelm in 2021 under an accelerated pathway, prompting several committee members to resign in protest, initiating the lawmakers’ probe. Energy and Commerce Committee chair Frank Palline Jr. (D-NJ) commented:
“While we all support the search for new cures and treatments to address devastating diseases like Alzheimer’s, we must ensure that expediency does not take precedence over protocols that ensure the independence and scientific rigour of FDA.”
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https://www.uncoverdc.com/2022/12/30/congressional-report-fda-inappropriately-collaborated-with-biogen/
>A House investigation has concluded that the Food and Drug Administration (FDA) “collaborated” with biotechnology company Biogen on the approval of its Alzheimer’s drug Aduhelm. Indeed, as 2022 comes to a close, American taxpayers are reminded yet again of the inappropriate and dishonest manner in which the FDA—the agency funded by taxpayers to ensure the safety and efficacy of the medications they take—collaborates with Big Pharma.
>Eighteen months in the making, the just-released report titled “The High Price of Aduhelm’s Approval: An Investigation into FDA’s Atypical Review Process and Biogen’s Aggressive Launch Plans” found that the FDA’s approval process was “rife with irregularities.” The two House of Representatives committees—Oversight and Reform and Energy and Commerce—investigated the drug’s regulatory review, approval, pricing, and marketing. The report points to “collaboration” between Biogen and the FDA ahead of an advisory committee meeting that nevertheless resulted in none of the eleven panelists voting in favor of approval for Aduhelm (aducanumab).
>Specifically, the FDA’s Peripheral and Central Nervous Systems Drugs Advisory Committee (PCNS Advisory Committee) overwhelmingly disagreed that the data proved the drug’s benefits to patients. The report notes the Committee members “did not agree that it was reasonable to consider the clinical benefit of the one successful trial as the primary evidence supporting approval.” Regardless, the FDA approved Aduhelm in 2021 under an accelerated pathway, prompting several committee members to resign in protest, initiating the lawmakers’ probe. Energy and Commerce Committee chair Frank Palline Jr. (D-NJ) commented:
>>“While we all support the search for new cures and treatments to address devastating diseases like Alzheimer’s, we must ensure that expediency does not take precedence over protocols that ensure the independence and scientific rigour of FDA.”
.
.
.
more
https://www.uncoverdc.com/2022/12/30/congressional-report-fda-inappropriately-collaborated-with-biogen/
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