House Dems fault FDA’s ‘atypical’ review process for Biogen’s Alzheimer’s drug
Abigail Adcox
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The Food and Drug Administration’s approval process for Biogen’s controversial Alzheimer’s drug was “rife with irregularities,” a report from House Democrats concluded.
The FDA’s collaboration with Biogen was “atypical” during the review process for Aduhelm and failed to adhere to the agency’s protocol for interacting with drug companies, which ultimately contributed to the drug being approved despite concerns over its effectiveness, according to a joint report by Democratic staff on the House Oversight and Energy and Commerce Committees.
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“The Committees’ review of these materials reveals that FDA’s review and approval of Aduhelm consisted of atypical procedures and deviated from the agency’s own guidance. These materials also reveal that Biogen had aggressive launch plans for Aduhelm —including in its label and pricing — despite concerns about efficacy, safety, and affordability,” the report reads. “The criticism surrounding Aduhelm’s approval may have been avoided had FDA adhered to its own guidance and internal practices.”
Biogen’s Aduhelm became the first new therapy for Alzheimer’s in nearly two decades to receive approval last year, despite the FDA’s advisory committee voting against approving the drug. It has since faced challenges on the market with an initial price tag of $56,000 annually, which Biogen later cut, and Medicare significantly limiting coverage of the drug.
The 18-month investigation by the two Democrat-led committees found that FDA officials and Biogen staff held at least 115 meetings, calls, and “substantive email exchanges” between July 2019 and July 2020, as Biogen prepared to seek approval for the drug ahead of a November 2020 meeting with the FDA’s advisory committee.
“FDA must take swift action to ensure that its processes for reviewing future Alzheimer’s disease treatments do not lead to the same doubts about the integrity of FDA’s review,” the report concluded.
The investigation also found that Biogen was aware of the financial burden the drug’s costly initial price tag of $56,000 would place on Medicare patients, yet moved forward with it to “maximize profits” despite estimating that Medicare patients would make up more than 85% of the drug’s target patient population at the time of its launch.
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“Biogen stands by the integrity of the actions we have taken,” the company said in a statement Thursday. “Alzheimer’s is a highly complex disease and we have learned from the development and launch of Aduhelm. That process is continuing to inform our work as Biogen introduces new innovative treatments to the market.”
The findings come as the FDA is expected to decide by Jan. 6, 2023, whether another Alzheimer’s drug, lecanemab, developed by Biogen and Eisai, should be granted accelerated approval.