House committee questions Biogen drug approval process

In January, the FDA is expected to decide whether another Alzheimer’s drug will be approved

A report by two House committees questioned the approval process for an Alzheimer’s drug produced by Biogen.

Congressional investigators called the Food and Drug Administration’s process "rife with irregularities."

The drug in question is Aduhelm, which was approved for use in 2021 even though research studies failed to prove it really helped patients.

The 18-month investigation detailed "atypical collaboration" between FDA regulators and a company it’s supposed to oversee.

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Aduhelm biogen

This image provided by Biogen shows a vial and packaging for the drug Aduhelm.  (Biogen via AP / AP Newsroom)

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 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."

FDA headquarter sign

FDA headquarters in Washington DC. (iStock / iStock)

In a statement Thursday, the FDA said the Aduhelm decision "was based on our scientific evaluation of the data." 

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Thursday’s report said FDA and Biogen engaged in an unusually high volume of phone calls, meetings and emails, some of them not properly documented.

The FDA said its internal review found its interactions with Biogen were appropriate.

Biogen said: "Alzheimer’s is a highly complex disease and we have learned from the development and launch of Aduhelm" but that it "stands by the integrity of the actions we have taken."

Biogen offices

The Biogen Inc. office in Cambridge, Massachusetts.  (: Scott Eisen/Bloomberg via Getty Images / Getty Images)

Biogen had halted two studies after disappointing results suggested the drug wasn’t slowing Alzheimer’s inevitable worsening -- only to later contend that a new analysis of one study showed higher doses offered an incremental benefit.

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Medicare refused to pay for the drug, even after the yearly price was dropped to $28,000 -- unless patients enrolled in clinical trials to prove if it indeed slowed cognitive decline.

The investigators recommended that FDA take steps to restore trust in the approval process that include properly documenting interactions with drugmakers.

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They also urged manufacturers to take into account advice from patient groups and other outside experts on fair drug pricing.

The Associated Press contributed to this report.