Third member of the U.S. Food and Drug Administration’s external advisory panel. It has resigned to protest the agency’s decision to approve Biogen Inc’s Alzheimer’s treatment, although the board has suggested not to do so.
Aaron Kesselheim, a professor of medicine at Harvard Medical School who has served on the FDA’s advisory board for neurologic drugs since 2015, told Reuters on Thursday he was stepping down from the panel.
“My reason is that the FDA needs to re-evaluate how claims are made and how the advisory board is used … because I don’t think solid recommendations from the board in this case … have been included. with proper decision making process,” Kesselheim said in an email.
He cited the FDA’s decision to approve Sarepta Therapeutic Inc’s drug eteplirsen for Duchenne muscular dystrophy in 2016 as another example of regulatory agencies that approved the drug on advisory board recommendations.
Stat News reported his departure for the first time.
On Tuesday, Dr. Joel Perlmutter, a neuroscientist at the University of Washington, A member of the advisory group voted against the approval. It has resigned from the board, citing Aduhelm’s approval from the FDA.
Mayo Clinic neurologist Dr. David Knopman said he resigned on Wednesday.
A panel of 11 members voted unanimously in November that Biogen’s drug should not be approved. It cited inconclusive evidence that the drug was effective.
on monday The Food and Drug Administration (FDA) has given the drug “accelerated approval” based on evidence that it can reduce the factors that cause Alzheimer’s disease. instead of proving beneficial against this disease.