US Congress report questions Alzheimer’s drug approval
The Aduhelm drug was approved in June 2021 through a controversial decision by the Food and Drug Administration (FDA) mainly because a group of independent experts did not find sufficient evidence of the benefit of this product in November 2020.
Today a report from Congress has released a warning of alleged irregularities in that process.
In a statement, the FDA stressed that it “remains committed to the integrity of our drug approval process, which includes ensuring safe and effective new treatment options are available to millions of Alzheimer’s patients.”
A report from the US Congress revealed Thursday that the approval process for a controversial Alzheimer’s drug by the US Food and Drug Administration (FDA) was “riddled with irregularities.”
The 18-month investigation into the green light given to the drug Aduhelm by the FDA also points to its maker, the biotech company Biogen.
The Cambridge, Massachusetts-based company set an “unreasonably high price” for Aduhelm, at $56,000 a year, for “making history” with the first drug approved in decades to treat Alzheimer’s, the report says.
Aduhelm received “expedited approval” from the FDA in June despite an independent panel advising the US drug regulator finding insufficient evidence of its benefits, and some experts have raised concerns about inconsistencies in clinical data. of the drug.
At least three of the 11 members of the independent committee that voted unanimously against issuing a recommendation of the drug to the FDA have since resigned.
Unprecedented opportunity
According to the parliamentary inquiry, the FDA “considered Aduhelm under the traditional approval process used for most drugs for nine months,
before abruptly changing course and granting approval under an expedited process and after a three-week review period.”
The researchers found that the interactions between the FDA and Biogen were “atypical” and included the lack of proper documentation of contacts between regulatory agency personnel and the drug manufacturer.
The FDA and Biogen also “inappropriately collaborated” on a joint briefing paper for a key advisory committee.
“The FDA approval process was riddled with irregularities,” the report states. As for Biogen,
the report notes that the company “saw Aduhelm as an unprecedented financial opportunity – estimating a maximum potential revenue of $18 billion per year.”
The investigation cites a 2020 company filing saying “our ambition is to make history” and “establish Aduhelm as one of the top pharmaceutical launches of all time.”
Call of attention
Carolyn Maloney, chair of the House Oversight and Reform Committee (lower) said she hoped the findings of this report would be “a wake-up call for the FDA to reform its practices.”
Frank Pallone, chairman of the Commerce and Energy Committee, said the report “documents the FDA’s atypical review process and corporate greed that preceded the FDA’s controversial decision to give Aduhelm expedited approval.”
We must make sure that urgency does not supersede procedure, Pallone added, “even while we all support research into novel cures and therapies for cruel diseases like Alzheimer’s.”
“Our national pharmaceutical regulatory review process must have patient safety and therapeutic efficacy at its core,” she continued.
The FDA emphasized in a statement that it “remains dedicated to the integrity of our medication approval process, which includes ensuring that safe and effective new treatment choices are available to millions of Alzheimer’s patients.”
The pharmaceutical company Biogen, on the other hand, argued that it “defends the integrity of the measures they have implemented.”
The business said, “Biogen has dedicated more than a decade to investigating and developing medicines for Alzheimer’s disease.”
To solve this global health issue, “We have continuously focused on innovation and have adjusted to both achievements and losses,”
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