RE: FDA29 Dec 2022 22:05
Dec. 29, 2022
Updated 2:54 p.m. ET
The FDA has been Slammed 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.
The investigation said Biogen was prepared to spend up to several billion dollars — more than two-and-a-half times what it spent developing the drug — on aggressive marketing to counter expected “pushback” over whether Aduhelm was worth its price. The report said the campaign planned to target doctors, patients, advocacy groups, insurers, policymakers and communities of color, who were drastically underrepresented in its clinical trials of the drug.
that means IMM P3 could have got approval, and in fact
anyone can get approval from them for the right price
if the DRUG have efficacy or not
scary stuff'' indeed, and will certainly be raising a few eyebrows
about other recently fast tracked big Pharma's with deep pocket Drugs
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