The approval and explanation riled advisory committee member Aaron Kesselheim, a professor at Harvard Medical School who is also director of the Program on Regulation, Therapeutics, and Law at Brigham and Women’s Hospital. In a searing resignation letter sent to acting FDA Commissioner Janet Woodcock on Thursday, Kesselheim called the FDA’s decision “probably the worst drug approval decision in recent US history.”
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In resigning, he joins neurologists David Knopman of the Mayo Clinic in Minnesota and Joel Perlmutter of Washington University in St. Louis, both of whom also announced resignations this week.
Three experts resign as FDA advisers over approval of Alzheimer’s drug