US drug regulators failed to follow their own guidance and practices when they approved the controversial Alzheimer’s drug Aduhelm, a congressional report said on Thursday.
The US food and drug administration’s (FDA) process of approval, it said, had been “rife with irregularities”, and the FDA’s interactions with maker Biogen had been “atypical”.
The report follows an 18-month regulatory review conducted by two House committees focused on the drug’s approval, pricing and marketing.
Biogen, the report found, had set an “unjustifiably high” price by initially pricing Aduhelm at $56,000 (£46,438) a year. The pricing was established despite a lack of demonstrated clinical benefit in a broad patient population.
The report said that the company’s own projections showed that it expected Aduhelm to be a burden to the government’s health insurer Medicare and costly to patients. After Biogen halved the cost, the federal insurer continued its coverage of the drug.
“The findings in this report raise serious concerns about FDA’s lapses in protocol and Biogen’s disregard of efficacy and access in the approval process for Aduhelm,” the report concluded.
FDA regulators approved Aduhelm in June 2021 under an accelerated process. The certification came over objections raised by a panel of outside advisers that had expressed doubts about its benefit to people suffering from Alzheimer’s-related dementia.
Aduhelm’s authorization was based on evidence that it could reduce brain plaques – or clumps of folded amyloid proteins, considered a probable contributor to Alzheimer’s – but not on proof that it slowed the progression of the disease.
The report found that Biogen had wanted to introduce a “blockbuster” to “establish Aduhelm as one of the top pharmaceutical launches of all time” and was prepared to commit several billion dollars – or more than two-and-a-half times what it had spent to develop the drug – promoting it to doctors, patients, advocacy groups, insurers and policymakers.
Biogen also planned to promote the drug to racial minority communities that had been underrepresented in drug trials, according to the report.
The report “documents the atypical FDA review process and corporate greed that preceded FDA’s controversial decision to grant accelerated approval to Aduhelm”, said a statement from Democratic congressman Frank Pallone, the chairperson of the House energy and commerce committee.
In a statement, the FDA said it would “fully cooperate with the committees’ evaluation”, and its responsibility is to frequently interact with companies to collect accurate information.
“The agency has already started implementing changes consistent with the committee’s recommendations,” the statement said.
In a statement after the report was published, Biogen said it stood by “the integrity of the actions we have taken”, adding: “Alzheimer’s is a highly complex disease, and we have learned from the development and launch of Aduhelm.”
Recommendations in the report included that the FDA maintain documentation of its interactions with drug companies, that companies communicate safety and efficacy concerns to the FDA, and that the actual value of a drug be considered when setting prices.
“The American people rely on the FDA for assurance on the safety and efficacy of the medications they take and it is incumbent upon drug companies such as Biogen to ensure that the wellbeing and safety of patients are prioritized,” the report said.