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. www.theguardian.com/us-news/2022/dec/29/biogen-fda-alzheimers-aduhelm-congressional-report?
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 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.