In June 2021, the Food and Drug Administration (FDA) approved a new drug, Aduhelm, to slow the progression of Alzheimer’s. However, multiple FDA staff, including the director of the Office of Biostatistics, and a panel of external FDA advisors objected to the drug’s approval, arguing that there is insufficient scientific evidence to demonstrate the drug’s effectiveness. Despite these concerns, the FDA approved the drug via an “accelerated approval” process. Politico reports, “[t]hree FDA advisory committee members resigned in protest over the drug approval.”
Update: The FDA’s approval of Aduhelm was the subject of a congressional inquiry which determined the approval process was “rife with irregularities.” Despite the drug’s approval, the drug manufacturer, Biogen, has since abandoned ownership rights and further clinical trials of the drug in light of the fact that “Aduhelm failed spectacularly in the marketplace.”