A congressional investigation into the FDA's review process for an Alzheimer's treatment found that the agency 'deviated' from its standard procedures to approve the Aduhelm drug with inconsistent data.
December 29, 2022, 6:11 PMA sign for the Food And Drug Administration is seen outside of the headquarters, July 20, 2020, in White Oak, Md.A congressional investigation into the Food and Drug Administration's review process for an Alzheimer's treatment found that the agency "deviated" from its standard procedures to approve the Aduhelm drug with inconsistent data.
In statements, Biogen and the FDA both said their interactions prior to Aduhelm's green light were appropriate in the context of the approval process. "The FDA's decision to approve Aduhelm was based on our scientific evaluation of the data contained in the application, which is described in the approval materials. … That said, the agency has already started implementing changes consistent with the Committee's recommendations," the statement said, in part.
"Alzheimer's is a highly complex disease and we have learned from the development and launch of Aduhelm. That process is continuing to inform our work as Biogen introduces new innovative treatments to the market," the statement read, in part. Although it is typical for drug companies to work closely with the FDA during the approval process, such collaboration between Biogen and its federal regulators "exceeded the norm in some respects," according to the FDA's own internal review, the report says.
The FDA later walked back its broad approval of the drug, eventually recommending the drug's use in only a narrower subset of patients with early-stage disease, which more closely mirrored the group included in Aduhelm's clinical trials.& Medicaid Services established that Medicare would only pay for the drug under limited circumstances in which patients are part of approved studies.
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