Follow-up Letter to the FDA’s Acting Commissioner Regarding the Agency’s Inappropriate Close Collaboration with Biogen on the Alzheimer’s Disease Drug Aducanumab
Public Citizen urged the FDA’s new Acting Commissioner to endorse our call for the Department of Health and Human Services’ Office of Inspector General to investigate the unprecedented and inappropriate close collaboration between the FDA and Biogen before and after the submission of the company’s biologics license application (BLA) for the new drug aducanumab for treatment of Alzheimer’s disease. We also urged her to publicly disclose whether she was ever made aware of, or whether she ever endorsed or facilitated in any way, the FDA’s close collaboration with Biogen prior to her assignment to Operation Warp Speed.
February 11, 2021, FDA response letter.
See Public Citizen’s other work on aducanumab.