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3 FDA Committee Members Resign Over Alzheimer’s Drug Approval
Following the approval of Biogen’s Alzheimer’s drug last week, 3 FDA advisory committee members have resigned after FDA ignored their input during the decision-making process.
By Samantha McGrail
June 14, 2021 - Three experts have resigned from FDA’s advisory committee following the agency’s approval of Biogen’s Alzheimer’s drug, aducanumab, according to multiple reports.
FDA approved aducanumab at the beginning of last week. This marked the first Alzheimer’s drug approval in nearly 20 years and the first one to address cognitive decline in patients with the illness.
In November 2020, FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted against recommending the drug.
Specifically, 10 of the 11 committee members voted that there was not enough evidence to show aducanumab could slow cognitive decline, recommending against its approval, according to STAT. The 11th member voted “uncertain.”
Joel Perlmutter, MD, a Washington University neurologist, was the first committee member to resign.
He stated that FDA approved the drug without further discussion with its advisors. Just days later, David Knopman, MD, a Mayo Clinic neurologist, panel member, and an investigator in clinical trials of Biogen’s drug, also resigned.
"I was very disappointed at how the advisory committee input was treated by the FDA," Knopman told Reuters following his resignation. "I don't wish to be put in a position like this again.”
Aaron Kesselheim, MD, professor at Harvard Medical School and director of the program on regulation, therapeutics, and law at Brigham and Women’s Hospital, was the last committee member to resign...
3 FDA Committee Members Resign Over Alzheimer’s Drug Approval
Following the approval of Biogen’s Alzheimer’s drug last week, 3 FDA advisory committee members have resigned after FDA ignored their input during the decision-making process.
By Samantha McGrail
June 14, 2021 - Three experts have resigned from FDA’s advisory committee following the agency’s approval of Biogen’s Alzheimer’s drug, aducanumab, according to multiple reports.
FDA approved aducanumab at the beginning of last week. This marked the first Alzheimer’s drug approval in nearly 20 years and the first one to address cognitive decline in patients with the illness.
In November 2020, FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted against recommending the drug.
Specifically, 10 of the 11 committee members voted that there was not enough evidence to show aducanumab could slow cognitive decline, recommending against its approval, according to STAT. The 11th member voted “uncertain.”
Joel Perlmutter, MD, a Washington University neurologist, was the first committee member to resign.
He stated that FDA approved the drug without further discussion with its advisors. Just days later, David Knopman, MD, a Mayo Clinic neurologist, panel member, and an investigator in clinical trials of Biogen’s drug, also resigned.
"I was very disappointed at how the advisory committee input was treated by the FDA," Knopman told Reuters following his resignation. "I don't wish to be put in a position like this again.”
Aaron Kesselheim, MD, professor at Harvard Medical School and director of the program on regulation, therapeutics, and law at Brigham and Women’s Hospital, was the last committee member to resign...