House report questions FDA’s approval of Alzheimer’s drug

WASHINGTON — A joint investigation released Thursday by House Democrats identified unusual collaboration between Food and Drug Administration officials and drugmaker Biogen, highlighting potential problems in the agency’s approval of the controversial Alzheimer’s drug Aduhelm.

The House Energy and Commerce and Oversight and Reform committees concluded their findings “raise serious concerns” about the drug’s approval process.

“The number of patients and families impacted by Alzheimer’s disease will continue to increase, and it is crucial that FDA and drug companies adhere to established procedures and conduct themselves with the transparency necessary to earn public trust,” Oversight and Reform Chair Carolyn B. Maloney, D-N.Y., said in a statement, calling the report a “wake-up call” for the FDA.

The FDA previously determined in an internal review that officials acted appropriately, but said it has already begun implementing the report’s recommendations.

“It is the agency’s job to frequently interact with companies in order to ensure that we have adequate information to inform our regulatory decision-making,” the agency said in a statement. “We will continue to do so, as it is in the best interest of patients.”

Biogen refuted the report’s implications, saying it “stands by the integrity of the actions we have taken.”

“As stated in the congressional report, an FDA review concluded that, ‘There is no evidence that these interactions with the sponsor in advance of filing were anything but appropriate in this situation,’” the company said.

The Federal Trade Commission and Securities and Exchange Commission also opened investigations into Biogen following the drug’s approval.

The FDA approved the drug in June 2021 on the condition that it receive additional follow-up data, but concerns over the drug’s efficacy and safety profile led the Centers for Medicare and Medicaid Services to restrict coverage of it and related drugs authorized through the FDA’s accelerated approval process to clinical trials.

The decision doomed the drug’s market potential and cast doubt on other monoclonal antibody drugs targeting brain plaques in Alzheimer’s patients. The FDA is also currently reviewing a similar drug, lecanemab, from Biogen and its Japan-based partner, Eisai. A decision on accelerated approval is due by Jan. 6, and the company is simultaneously submitting data for full approval based on results from a Phase 3 trial.

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