Two Members Of FDA Panel Resign In Protest Over Alzheimer's Drug Approval
By Bill Galluccio
June 10, 2021
Two members of the Food and Drug Administration's Peripheral and Central Nervous System Drugs Advisory Committee have resigned in protest over the approval of a drug made by Biogen to treat Alzheimer's disease.
In November, the panel unanimously voted against approving the drug aducanumab because there was inconclusive evidence that it was effective at helping patients.
In a rare move, the FDA decided to go against the committee's recommendation and granted the drug an "accelerated approval" on Monday (June 7). The agency said that the drug, which costs $56,000 per year and is administered as an infusion, could reduce levels of amyloid in the brain, which could help slow the cognitive decline in some patients.
After the drug was approved, two members of the committee tendered their resignation. Neurologist Dr. David Knopman, who recused himself from the vote because he was an investigator in clinical trials of Biogen's drug, said he felt the FDA disrespected the panel by ignoring their recommendation.
"I was very disappointed at how the advisory committee input was treated by the FDA," Dr. Knopman told Reuters. "I don't wish to be put in a position like this again."
Washington University neurologist Dr. Joel Perlmutter, who voted against approving the drug, also resigned.