Probe: Alzheimer's drug approval 'rife with irregularities'
The Food and Drug Administration's contentious approval of a questionable Alzheimer's drug is taking another hit
WASHINGTON (AP) — The Food and Drug Administration’s contentious approval of a questionable Alzheimer’s drug took another hit Thursday 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.”
The FDA and Biogen issued statements Thursday defending the Aduhelm approval process.
