The Food and Drug Administration's review and approval process for the Alzheimer's drug Aduhelm was rife with irregularities, according to a congressional report released Thursday.
The findings of an 18-month investigation undertaken by two House committees raised serious concerns about the FDA's lapses in protocol and drugmaker Biogen's "disregard of efficacy and access in the approval process for Aduhelm."
The report said the FDA granted accelerated approved to Aduhelm, which targets amyloid beta plaque in the brain, in June 2021, even though Biogen canceled clinical trials in March 2019 after an independent report showed the drug was unlikely to effectively slow cognitive and functional impairment and that further clinical study would be futile.
"While we all support the search for new cures and treatments to address devastating diseases like Alzheimer's, we must ensure that expediency does not take precedence over protocols that ensure the independence and scientific rigor of FDA," said House Energy and Commerce Committee Chair Frank Pallone Jr., D-N.J., in a joint news release with Oversight and Reform Committee Chair Carolyn Maloney, D-N.Y.
More than 6 million people in the U.S. are affected by Alzheimer's, a degenerative brain disease. The report said up to 14 million could be affected by 2060. There is no known cure.
The committees launched their joint investigation shortly after the drug's approval, following concerns about the FDA's review of Aduhelm, questions about the drug's clinical benefit, and the high price of Aduhelm set by Biogen.
"The criticism surrounding Aduhelm's approval may have been avoided had FDA adhered to its own guidance and internal practices," the report found.
The report said internal documents from Biogen showed the company was going to set the drug's price at $56,000 a year "despite a lack of demonstrated clinical benefit in a broad patient population," and that the company was expecting an "unprecedented financial opportunity" with peak revenue of $18 billion a year from sales of the drug. The report also said internal documents showed Biogen was aware the financial burden would fall primarily on Medicare and government programs would account for 90% of the patient population.
The report also found FDA and Biogen officials "inappropriately collaborated" on a joint briefing document for a key FDA advisory committee, which ended up not recommending the drug. Still, the FDA went ahead and approved the drug, leading some members of the advisory committee to resign.
Another Alzheimer's drug by Biogen is under review by the FDA, and the report said the FDA "must take swift action to ensure that its processes for reviewing future Alzheimer's disease treatments do not lead to the same doubts about the integrity of FDA's review."
It also said Biogen "must provide more transparency into its pricing and analyses of clinical benefit to ensure that new drugs are effective and available for those who need them."
"We fully cooperated with the committees' evaluation, and we continue to review their findings and recommendations," the FDA said in a statement emailed to Newsmax. "The agency has already started implementing changes consistent with the Committee's recommendations."
The Wall Street Journal quoted a Biogen spokesperson as saying: "Biogen stands by the integrity of the actions we have taken."
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