WASHINGTON — The Food and Drug Administration’s review and approval of a controversial Alzheimer’s drug was “rife with irregularities,” including dozens of undisclosed calls and emails with Biogen and an “inappropriate” level of coordination between the drugmaker and regulators, a congressional investigation concluded.
In a report released Thursday, two House committees faulted regulators at the FDA for glossing over sharp internal disagreements about the merits of the treatment, Aduhelm, and for advocating its approval for a far broader patient population than had been studied.
Among the documents investigators unearthed in their 18-month investigation are an internal review by the FDA of Aduhelm’s approval process that has not previously been made public. The investigation also disclosed the most comprehensive accounting of the FDA’s interactions and collaboration with Biogen ahead of a crucial presentation to the agency’s advisers.
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