The Food and Drug Administration's contentious approval of a questionable Alzheimer's drug is taking another hit.
FILE - This image provided by Biogen on Monday, June 7, 2021 shows a vial and packaging for the drug Aduhelm. The Food and Drug Administrations contentious approval of a questionable Alzheimers drug took another hit Thursday, Dec. 29, 2022, as congressional investigators called the process rife with irregularities.
The 18-month investigation by two House committees detailed “atypical collaboration” between FDA regulators and a company it’s supposed to oversee -- Aduhelm manufacturer Biogen. The probe also cited Biogen documents saying the company intended to “make history” when it set what investigators called an “unjustifiably high” initial price of $56,000 a year for the drug.
The criticism comes as the FDA is expected to decide whether to approve another new Alzheimer’s drug in January. Thursday’s report urged the agency to “take swift action” to ensure that any future Alzheimer's approvals aren’t met with “the same doubts about the integrity of FDA’s review.”In 2021, the FDA overruled its own independent scientific advisers when itAduhelm even though research studies failed to prove it really helped patients.
The FDA argued the drug’s ability to reduce a hallmark of Alzheimer’s, a buildup of plaque in the brain, suggested it was likely to slow the disease. Backlash was immediate as three FDA advisers resigned in protest and the agency’s then-acting chief
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