U.S. drug regulators did not follow their own guidelines and practices when approving the controversial Alzheimer’s drug Aduhelm, a congressional report said Thursday.
The US Food and Drug Administration (FDA) approval process, he said, had been “riddled with irregularities”, and the FDA’s interactions with manufacturer Biogen had been “atypical”. .
The report follows an 18-month regulatory review conducted by two House committees focused on approval, pricing and marketing of the drug.
Biogen, according to the report, had priced it “unjustifiably high” by initially pricing Aduhelm at $56,000 (£46,438) per year. Pricing was established despite the lack of demonstrated clinical benefit in a large patient population.
The report says the company’s own projections show it expects Aduhelm to be a burden on government Medicare health insurance and costly for patients. After Biogen halved the cost, the federal insurer continued coverage of the drug.
“The findings of this report raise serious concerns about the FDA’s failings in protocol and Biogen’s disregard for Aduhelm’s efficacy and access to the approval process,” the report concludes.
FDA regulators approved Aduhelm in June 2021 in an expedited process. The certification came despite objections from a group of outside advisers who had expressed doubts about its benefits for people with dementia linked to Alzheimer’s disease.
Aduhelm’s approval was based on evidence that it could shrink brain plaques – or clumps of folded amyloid proteins, thought to be a likely contributor to Alzheimer’s disease – but not on evidence that it slowed progression of the disease.
The report revealed that Biogen had wanted to introduce a “blockbuster” to “establish Aduhelm as one of the best pharma launches of all time” and was prepared to commit several billion dollars – more than two and a half times what he 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 the FDA’s controversial decision to grant expedited approval to Aduhelm,” said a statement from Democratic Congressman Frank Pallone, chairman. of the House Energy and Commerce Committee.
In a statement, the FDA said it would “cooperate fully with the committee’s evaluation,” and its responsibility is to interact frequently with the companies to gather accurate information.
“The agency has already begun implementing changes consistent with the committee’s recommendations,” the statement said.
In a statement after the report was released, Biogen said it supports “the integrity of the actions we have taken”, adding, “Alzheimer’s disease is a very complex disease, and we have learned from the development and launch of Aduhelm”.
The report’s recommendations included that the FDA keep documentation of its interactions with pharmaceutical companies, that companies communicate their safety and efficacy concerns to the FDA, and that a drug’s true value be considered when of pricing.
“The American people rely on the FDA to ensure the safety and effectiveness of the drugs they take, and it is the responsibility of pharmaceutical companies such as Biogen to ensure that the well-being and safety of patients is met. priorities,” the report said.