Three members of an FDA advisory panel have resigned in the wake of the agency’s “accelerated approval” of controversial Alzheimer’s drug that would cost patients $56,000/year.
Backlash over the U.S. Food and Drug Administration’s controversial approval of a new Alzheimer’s drug grew late last week with a third member of an agency advisory panel resigning in protest.
The latest resignation to hit the Peripheral and Central Nervous System Drugs Advisory Committee, as STAT first reported, came from Dr. Aaron Kesselheim, a Harvard Medical School professor.
His action followed FDA’s “accelerated approval” announced early last week for aducanumab, on which drug maker Biogen put an annual price tag of $56,000. Administered as a monthly intravenous infusion, it’s the first drug to treat Alzheimer’s disease that’s been approved in nearly two decades — approval that came despite the panel’s recommendation against it in light of lack of data showing efficacy.
In his resignation letter, Kesselheim wrote that it “was probably the worst drug approval decision in recent U.S. history,” CNBC reported.
“At the last minute,” wrote Kesselheim, “the agency switched its review to the Accelerated Approval pathway based on the debatable premise that the drug’s effect on brain amyloid was likely to help patients with Alzheimer’s disease.”
The FDA erred in its approval, Kesselheim added to the New York Times, “because of so many different factors, starting from the fact that there’s no good evidence that the drug works.”