A report by multiple House Committees found the U.S. Food and Drug Administration (FDA) inappropriately colluded with drug company Biogen before approving its Alzheimer’s Drug Aduhelm.
The report was released Thursday after an 18 month investigation by the House Oversight and Energy and Commerce Committees into the FDA’s decision to approve Aduhelm.
BREAKING: The FDA “inappropriately” collaborated with Biogen when evaluating its Alzheimer’s treatment, Aduhelm, a new Congressional report says https://t.co/1tqMzEiExB
— Liz Essley Whyte (@l_e_whyte) December 29, 2022
FDA officials and Biogen had at least 115 calls, 40 meetings and many email exchanges over the course of a year starting in July 2019, according to the committee report. These interactions were “atypical” and failed to follow the FDA’s documentation protocols, the report says. (RELATED: As Government Money Dries Up, Pfizer Eyes Covid Vaccine Price Hikes)
The FDA and Biogen inappropriately collaborated on a briefing document for the PCNS Advisory Committee that did not reflect differing views inside the agency, the report added. After nine months on the traditional approval pathway, the FDA abruptly changed course to an accelerated timeline to get Aduhelm approved, the report notes.
Biogen had cancelled clinical trials in March 2019 because an independent report indicated Aduhelm was not effective, the report says. The FDA approval gave Aduhelm for treatment on an ever broader population than Biogen studied in its clinical trials, the report continued.
Biogen initially set the price of Aduhelm at $56,000 and expected it to be a costly financial burden for Medicare patients, over 85% of the drug’s expected target population at the time of its launch, the report says.
The committees recommend the FDA ensure that interactions with drug companies are properly recorded, establish a protocol for joint briefing documents and update its industry guidance for Alzheimer’s drugs for the agency to restore trust.
The committees also recommend for Biogen and other drug sponsors to communicate safety concerns to the FDA, and consider value assessments by outside experts when setting drug prices.