Biogen, FDA faulted in congressional inquiry into Alzheimer’s drug approval
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A congressional investigation has faulted the Food and Drug Administration (FDA) and Biogen (NASDAQ:BIIB) for collaborating âinappropriatelyâ to seek the regulatory nod for Aduhelm, which in 2021 became the first U.S.-approved treatment for Alzheimerâs disease in nearly two decades.
The Democrat-led House Oversight and Reform Committee and the Energy and Commerce Committee presented the findings on Thursday after an 18-month investigation into the review, approval, and marketing of Aduhelm developed by Biogen (BIIB) with Eisai (OTCPK:ESALY) (OTCPK:ESALF).
âFDA and Biogen inappropriately collaborated on a joint briefing document for the PCNS advisory committee that did not adequately represent differing views within FDA,â the committee said in its report, referring to a panel of independent experts that voted against the approval of Aduhelm in 2020.
âThe Committees obtained evidence that FDA and Biogen staff worked closely for several months ahead of the November 6, 2020, PCNS Advisory Committee meeting to prepare the joint briefing document for the Committeeâs review,â the report said.
The committee members also criticized Biogen (BIIB) âfor setting an unjustifiably high price for Aduhelm to âmake historyâ for the company despite the impact on patients and the medicare program.â
Biogen (BIIB) and Eisai (OTCPK:ESALF) faced payor pushback this year after setting an annual price of $56K for Aduhelm before cutting it to $28K amid concerns over its efficacy and cost.
The report comes ahead of a possible FDA decision in January on the companiesâ new Alzheimerâs therapy, lecanemab, which, according to drug pricing watchdog Institute for Clinical and Economic Review (ICER), should be priced at ~$9K-$21K per year.