Skip to content Skip to sidebar Skip to footer

After quitting FDA adcomm in protest of Aduhelm decision, Harvard's Aaron Kesselheim finds agency has an approval bias


The ill-fated launch of Biogen’s Alzheimer’s disease treatment Aduhelm raised many questions, including this: Why did the FDA sign off on the drug after an independent advisory committee recommende | A study of FDA advisory committee meetings between 2010 and 2021 shows that the regulator leaned heavily toward approval. When a panel recommended approval, the FDA agreed 97% of the time. When a panel recommended a thumbs-down, however, the FDA complied only 67% of the time.


Leave a comment