Here are some excerpts from an article that discus
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Posted On: 01/03/2023 9:39:36 PM
Here are some excerpts from an article that discusses the relationship between Biogen and the FDA while their Alzheimer’s drug Aduhelm was under review. No direct connection to CYDY, but I thought the discussion about the FDA was interesting.
Congressional inquiry into 'highly atypical' FDA-Biogen ties ends with damning report, no repercussions
The FDA’s controversial approval of Biogen’s amyloid-targeted Alzheimer’s drug Aduhelm was “highly atypical” and “deviated” from FDA’s standard practices “in significant respects,” two key congressional committees late last week said in a report following an 18-month investigation into what transpired.
While the cozy ties that contributed to the approval, as revealed in this new report, may look like a slap in the face for both Biogen and FDA, at the end of the day the report offers a roadmap for how other companies may leverage behind-the-scenes interactions with FDA leaders to their advantage, and neither Biogen nor the FDA will face any consequences for their actions, at least as part of this investigation. The SEC, FTC and HHS’ OIG inquiries are still probing what happened.
The final congressional report, based on multiple briefings with FDA and congressional staff who reviewed more than 500,000 pages of documents from FDA and Biogen, reveals an uncharacteristically close relationship between the head of FDA’s neuroscience division, Billy Dunn, and senior executives at Biogen, that was never documented, with FDA noting in its own internal review of the situation that there isn’t even a “clear record of the number and nature of interactions between the sponsor and FDA.”
Whereas pharma companies frequently complain about not enough engagement with the FDA during any given drug’s approval process, this investigation found FDA and Biogen engaged at every level, across at least 115 meetings, calls and email exchanges concerning Aduhelm’s application , and featuring “ at least 45 collaborative workstream meetings ” that Dunn and Samantha Budd Haeberlein, Biogen’s head of clinical development, attended and that were outside the normal stream of FDA-sponsor meetings.
The Boston-based company, working off the claim that Aduhelm delays moderate Alzheimer’s by 2.6 years, was ready to pump more than $3.3 billion into sales and marketing of the drug from 2020 to 2024, which according to the congressional report, amounts to more than two and a half times what Biogen spent in total R&D on the drug dating back to 2007.
https://endpts.com/congressional-inquiry-into...rcussions/
Congressional inquiry into 'highly atypical' FDA-Biogen ties ends with damning report, no repercussions
The FDA’s controversial approval of Biogen’s amyloid-targeted Alzheimer’s drug Aduhelm was “highly atypical” and “deviated” from FDA’s standard practices “in significant respects,” two key congressional committees late last week said in a report following an 18-month investigation into what transpired.
While the cozy ties that contributed to the approval, as revealed in this new report, may look like a slap in the face for both Biogen and FDA, at the end of the day the report offers a roadmap for how other companies may leverage behind-the-scenes interactions with FDA leaders to their advantage, and neither Biogen nor the FDA will face any consequences for their actions, at least as part of this investigation. The SEC, FTC and HHS’ OIG inquiries are still probing what happened.
The final congressional report, based on multiple briefings with FDA and congressional staff who reviewed more than 500,000 pages of documents from FDA and Biogen, reveals an uncharacteristically close relationship between the head of FDA’s neuroscience division, Billy Dunn, and senior executives at Biogen, that was never documented, with FDA noting in its own internal review of the situation that there isn’t even a “clear record of the number and nature of interactions between the sponsor and FDA.”
Whereas pharma companies frequently complain about not enough engagement with the FDA during any given drug’s approval process, this investigation found FDA and Biogen engaged at every level, across at least 115 meetings, calls and email exchanges concerning Aduhelm’s application , and featuring “ at least 45 collaborative workstream meetings ” that Dunn and Samantha Budd Haeberlein, Biogen’s head of clinical development, attended and that were outside the normal stream of FDA-sponsor meetings.
The Boston-based company, working off the claim that Aduhelm delays moderate Alzheimer’s by 2.6 years, was ready to pump more than $3.3 billion into sales and marketing of the drug from 2020 to 2024, which according to the congressional report, amounts to more than two and a half times what Biogen spent in total R&D on the drug dating back to 2007.
https://endpts.com/congressional-inquiry-into...rcussions/
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