Two FDA Panel Members Resign Over Alzheimer's Drug Approval

 Two members of the US Food and Drug Administration's (FDA's) Peripheral and Central Nervous System Drugs Advisory Committee have resigned following the agency's approval of the controversial Alzheimer's drug aducanumab (Aduhelm, Biogen/Eisai), against the committee's recommendation.

One of the advisory panel members is David Knopman, MD, a clinical neurologist from the Mayo Clinic in Rochester, Minnesota, who was excluded from participating on the committee for the aducanumab meeting because of his involvement in clinical trials of the drug, and who is a known critic of aducanumab.

"I have been previously honored to serve on the committee as I believed the FDA Advisory committees provided valuable input to the FDA and to the public, Knopman told Medscape Medical News.

"I understand that the advisory committees are just that — advisory — but, the whole saga of the approval of aducanumab, from the biased questions posed to the committee on Nov 6, 2020 at the public hearing to the announcement of the accelerated approval 2 days ago, was deeply disrespectful to the committee members and denigrated their role.

https://www.medscape.com/viewarticle/952802