Health Alert: FDA, drug firm Biogen ignored internal concerns in approval of Alzheimer’s treatment, House panels say in scathing review

An investigation concluded that Biogen and the Food and Drug Administration ignored internal concerns from the company and skirted the agency's own written guidance to allow the Alzheimer's treatment Aduhelm to receive accelerated approval and hit the market at a cost to patients of $56,000 a year. The "unusual" collaboration unfolded through at least 115 meetings, calls and email exchanges between the company and the FDA in a year, said the report released Thursday by the Committees on Oversight and Reform, and Energy and Commerce. ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌  ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌  ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌  ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌  ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌  ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌  ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌  ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌  ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌  ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌

Sign up for alerts Health Alert Dec. 29, 2:30 p.m. EST FDA, drug firm Biogen ignored internal concerns in approval of Alzheimer's treatment, House panels say in scathing review An investigation concluded that Biogen and the Food and Drug Administration ignored internal concerns from the company and skirted the agency's own written guidance to allow the Alzheimer's treatment Aduhelm to receive accelerated approval and hit the market at a cost to patients of $56,000 a year. The "unusual" collaboration unfolded through at least 115 meetings, calls and email exchanges between the company and the FDA in a year, said the report released Thursday by the Committees on Oversight and Reform, and Energy and Commerce. Read more   Advertisement

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