WASHINGTON, D.C. — Acting U.S. Food and Drug Administration (FDA) Commissioner Janet Woodcock announced today that she has asked the U.S. Department of Health and Human Services (HHS) Acting Inspector General (IG) to investigate the “interactions between Biogen and the FDA during the process leading to the decision to approve” aducanumab for treatment of Alzheimer’s disease. On January 28, Public Citizen sent a letter to Dr. Woodcock urging her to endorse our call for an HHS OIG investigation of this unprecedented, inappropriately close collaboration between the FDA and Biogen. Dr. Michael Carome, director of Public Citizen’s Health Research Group, released the following statement:
“Public Citizen welcomes Dr. Woodcock’s belated request for an independent IG investigation of her agency’s inappropriately close collaboration with Biogen, as we had urged her to do nearly six months ago.
“Such an investigation must be broad and determine when Dr. Woodcock first became aware of this collaboration and whether she ever specifically endorsed or facilitated it in any way. The IG also must examine how Dr. Woodcock fostered a culture within the FDA’s Center for Drug Evaluation and Research that permitted and encouraged such an inappropriate collaboration with regulated industry. Under her leadership over the past three decades, the relationship between the FDA and the pharmaceutical industry has grown ever cozier — resulting in regulatory capture of the agency by industry.
“It is also imperative that Congress proceed expeditiously with its own announced investigation of the FDA-Biogen collaboration to ensure a thorough assessment and public airing of the circumstances that lead to the FDA’s reckless and inexcusable decision to approve aducanumab.”