Congress slams FDA approval of Aduhelm as ‘riddled with irregularities’
The US Food and Drug Administration’s approval process for Biogen Inc.’s controversial Alzheimer’s drug was “riddled with irregularities,” raising serious concerns about protocol errors at the agency, congressional investigators said.
According to the report of an 18-month investigation released Thursday by two House Oversight and Reform committees and Energy and Commerce committees, the Food and Drug Administration cooperated excessively with Biogen when evaluating the drug, called Aduhelm.
Aduhelm was acquitted despite objections from a panel of outside medical experts who advised the FDA not to market the drug, citing conflicting results from studies into its effectiveness; Three members of this body resigned after approval. The US Medicare program later severely restricted payment for Aduhelm, and Biogen halted its marketing efforts.
The report “describes a pattern of incredibly troubling behavior surrounding the approval of this drug,” said Aaron Kesselheim, a Harvard Medical School professor who left the advisory panel after Aduhelm’s approval. “The FDA is the world’s foremost public health regulator, but by taking such steps it damages its own credibility and the trust that patients and physicians place in them.”
Aduhelm received approval in June 2021, not because it showed efficacy against brain atrophy, but because of its ability to reduce amyloid plaques in the brain, a physical marker associated with the disease. Another experimental drug that reduces amyloid, Eisai Co.’s lecanemab, which is being developed in collaboration with Biogen, showed positive results in slowing the disease in September.
Frequent Interactions
Biogen said it has been committed to researching and developing treatments for Alzheimer’s disease for more than a decade and stands by the integrity of its actions. The FDA said it remains committed to the integrity of its approval process and that its internal review found that employees’ collaboration with Biogen was appropriate.
“It is the agency’s job to frequently interact with companies to ensure we have adequate information to make our regulatory decisions,” the FDA said in a statement.
Biogen viewed Aduhelm as an “unprecedented financial opportunity,” according to the congressional report, which criticized Biogen for setting an unreasonably high price of $56,000 per year for the product. The company developed aggressive rollout and marketing plans to maximize revenue, despite knowing the treatment would be costly to patients and a burden on Medicare, the report said.
Biogen has since lowered the price of Aduhelm to $28,200 to lower its own cost to patients and reduce “the potential financial impact on the U.S. healthcare system.” However, this decision was only made after public backlash, the report said.
wide label
The FDA initially approved the treatment with a label that allowed its use in a broad range of Alzheimer’s patients, rather than very early-stage patients, who were the primary subjects the drug was being studied in. Even as the company accepted the broader use statement, there were internal concerns about a lack of evidence to support it, investigators noted. According to the report, Biogen only later tried to limit the conditions for using the drug after public criticism.
Documents obtained by congressional committees revealed that the FDA and Biogen held “at least 115 meetings, phone calls and substantial email exchanges” over a 12-month period as Biogen worked to finalize and submit its application for Aduhelm . That may have been an undercount, since the FDA didn’t have a clear record of its meetings with Biogen.
The FDA also used a controversial route called accelerated approval to evaluate Aduhelm. Critics have said the pathway allows many drugs to enter the market based on questionable data.
The FDA said it will continue to use the expedited route when appropriate, as it gives the agency earlier access for serious, life-threatening conditions.
The report’s findings should be “a wake-up call for the FDA to reform its practices,” New York Representative Carolyn Maloney, chair of the Oversight and Reform Committee, said in a statement.
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