From StatNews.com….
A third member of a Food and Drug Administration expert panel has resigned over the agency’s contentious approval of an Alzheimer’s therapy this week, a sign of a growing backlash over the decision.
In a letter to acting FDA Commissioner Janet Woodcock on Thursday, Aaron Kesselheim, who had served on the FDA’s advisory committee for nervous system therapies since 2015, wrote that the approval of Biogen’s Aduhelm “was probably the worst drug approval decision in recent U.S. history.”
“It is clear to me that FDA is not presently capable of adequately integrating the Committee’s scientific recommendations into its approval decisions,” wrote Kesselheim, the director of Brigham and Women’s Hospital’s Program on Regulation, Therapeutics, and Law. He also cited the FDA’s decision to approve Sarepta Therapeutics’ eteplirsen for Duchenne muscular dystrophy in 2016 over the recommendation of the advisory committee in his decision to quit.
