Golly, what a surprise, the FDA violated its own g
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Quote:
The Food and Drug Administration’s process for approving the Alzheimer’s drug Aduhelm, despite great uncertainty about whether it worked, was “rife with irregularities,” according to a congressional investigation released on Thursday. The agency’s actions “raise serious concerns about F.D.A.’s lapses in protocol,” the report concluded.
The 18-month investigation, initiated by two congressional committees after the F.D.A. approved the drug, also strongly criticized Biogen, Aduhelm’s manufacturer. Internal documents showed the company set “an unjustifiably high price” of $56,000 a year for Aduhelm because it wanted a history-making “blockbuster” to “establish Aduhelm as one of the top pharmaceutical launches of all time,” even though it knew the high price would burden Medicare and patients, the report found.
https://www.nytimes.com/2022/12/29/health/alz...be517a9e6e