The New York Times Cites Public Citizen’s Letters Calling for FDA Investigation
By Pam Belluck, Sheila Kaplan, and Rebecca Robbins
“After receiving letters in December and January from the consumer advocacy group Public Citizen calling for an inspector general’s investigation of the collaboration, the F.D.A. began an internal review focusing on the issue.
The inquiry took place during the spring, as the decision deadline on the drug loomed, and was conducted by an office in the Center for Drug Evaluation and Research. The center includes the office that led the aducanumab assessment. Public Citizen said it was not informed that the inquiry was taking place. Biogen said the F.D.A. had not contacted the company in the inquiry.”