The Big Question: Is the FDA’s Drug Approval Process Broken?
A Q&A with physician and former FDA advisor Aaron Kesselheim on why he resigned to protest the approval of a new Alzheimer’s drug — and the reforms necessary to prevent it from happening again.
Will patients benefit from Biogen’s big win?
Photographer: Bloomberg/Bloomberg
This is one of a series of interviews by Bloomberg Opinion columnists on how to solve the world’s most pressing policy challenges. It has been edited for length and clarity.
Max Nisen: In November, a prestigious FDA advisory committee you sit on overwhelmingly voted that there wasn’t convincing evidence that Biogen Inc.’s Alzheimer’s drug aducanumab helps patients. The FDA approved it anyway earlier this month, and you resigned in protest. Most people don’t know what these advisory committees do. What purpose do they serve, and how did you end up on one?
Dr. Aaron Kesselheim, Professor of Medicine, Brigham and Women’s Hospital Division of Pharmacoepidemiology and Pharmacoeconomics, and Harvard Medical School: An advisory committee is a group of outside experts that the FDA impanels to help it address controversial questions or questions it needs advice on. The FDA has many advisory committees covering different areas of medicine. Usually, there’s a mix of expertise. For example, on our advisory committee, there were people with expertise in clinical medicine, biostatistics, and epidemiology. There was also a consumer representative and an industry representative.