A third member of a panel of outside advisers to the U.S. Food and Drug Administration has resigned in protest over the agency's decision to approve B

Third member of FDA advisory panel resigns over Alzheimer's drug approval

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2021-06-11 01:30:03

A third member of a panel of outside advisers to the U.S. Food and Drug Administration has resigned in protest over the agency's decision to approve Biogen Inc's Alzheimer's disease treatment despite the committee's recommendation against doing so.

Aaron Kesselheim, a Professor of Medicine at Harvard Medical School who had served on the FDA’s advisory committee for nervous system drugs since 2015, told Reuters on Thursday he was stepping down from the panel.

"My rationale was that the FDA needs to re-evaluate how it solicits and uses the advisory committees ... because I didn’t think that the firm recommendations from the committee in this case ... were appropriately integrated into the decision-making process," Kesselheim said in an email.

He cited FDA's decision to approve Sarepta Therapeutic Inc's drug, eteplirsen, for Duchenne muscular dystrophy in 2016 as another example of the regulator approving a drug against the recommendations of its advisory committee.