WASHINGTON, D.C. — The U.S. Department of Health and Human Service’s Office of Inspector General (OIG) announced today that in response to concerns raised about the U.S. Food and Drug Administration’s (FDA’s) process for reviewing and approving aducanumab (Aduhelm) for treatment of Alzheimer’s disease, the OIG will review and assess how the FDA implemented the accelerated approval pathway for this drug and a sample of other drugs approved under this regulatory pathway. On Dec. 9, Public Citizen called on the OIG to investigate the unprecedented collaboration between the FDA and Biogen regarding the company’s marketing application for aducanumab. Dr. Michael Carome, director of Public Citizen’s Health Research Group, released the following statement:
“Public Citizen welcomes the OIG’s announcement today that it finally will launch a review the FDA’s implementation of the accelerated approval pathway for aducanumab and other drugs. Such an independent review is long overdue. We are particularly pleased that the OIG’s evaluation will include an examination of the interactions between the FDA and outside parties during the review and approval process of these drugs.
“In the case of aducanumab, the unprecedented, inappropriately close collaboration between the FDA and Biogen before and after the company submitted its marketing application for the drug dangerously compromised the independence and objectivity of the agency’s review.”