Investigation Finds Irregularities in FDA Approval of Alzheimer's Drug

The congressional investigation found that the U.S. Food and Drug Administration's (FDA) approval for the Alzheimer's disease drug process entailed inappropriate collaboration and was accelerated despite the lack of clinical data.

The 18-month investigation looked at Biogen Inc.'s drug Aduhelm (aducanumab) regulatory review and approval, pricing, and marketing process.

The report released on Thursday reveals that the process entailed "inappropriate collaboration" between the FDA and Biogen. The agency granted accelerated approval for Aduhelm as a treatment for a broad population despite the lack of clinical data.

In addition, the company set "an unjustifiably high price" for the drug, knowing that it would primarily burden Medicare.

Biogen canceled clinical trials for Aduhelm in March 2019 following an independent report indicating that the drug was unlikely to effectively slow cognitive and functional impairment and that further clinical study would be futile.

Later that year, the FDA and Biogen began a "working group" collaboration to examine data from Biogen's failed clinical trials.

In 2020, the FDA and Biogen prepared and presented a joint briefing document to FDA's Peripheral and Central Nervous Systems Drugs (PCNS) Advisory Committee. None of the committee members voted to recommend traditional approval for Aduhelm.

Despite concerns about the drug's clinical data inconsistency, the FDA granted accelerated approval to Aduhelm on June 7, 2021.

What did the investigation find?

The Committee on Oversight and Reform and Committee on Energy and Commerce found that the agency "inappropriately collaborated" with Biogen on a joint briefing document for the PCNS Advisory Committee.

The FDA granted the company" advance insight into FDA's responses and direct guidance from the agency in drafting the company's own sections."

Moreover, the FDA approved Aduhelm for treating "people with Alzheimer's disease" — a far broader population than Biogen studied in its clinical trials. The report cites the lack of clinical data on disease stages other than mild cognitive impairment (MCI) and mild dementia stage of the disease.

Despite considering Aduhelm under the traditional approval pathway for nine months, the FDA suddenly approved the drug under the accelerated approval pathway after just three weeks.

The investigation also reveals that Biogen set "an unjustifiably high price" for Aduhelm at $56,000 per year despite a lack of demonstrated clinical benefit in a broad patient population.

The company documents show that Biogen was aware that the financial burden of its high price for Aduhelm would fall primarily on Medicare, projecting that government programs would collectively account for 90 percent of the patient population.

An estimated 6.5 million people aged 65 and older are living with Alzheimer's in the U.S. Currently, there is no cure for Alzheimer's disease, but there are medicines to manage the symptoms temporarily.


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