STAT+: ‘Rife with irregularities’: Congressional investigation reveals FDA’s approval of Aduhelm marked by secret discussions, breaches of protocol
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.
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