Letter: Woodcock Must Be Investigated as Part of IG’s Probe Into Aducanumab’s Approval

What Woodcock Knew About Her Agency’s Collaboration With Biogen and When Must Be Determined

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WASHINGTON, D.C.  Acting U.S. Food and Drug Administration (FDA) Commissioner Janet Woodcock must be investigated as part of the independent investigation of the approval of aducanumab for treatment of Alzheimer’s disease following the unprecedented, inappropriately close collaboration between Biogen and the agency to bring the drug to market, Public Citizen said in a letter to Christi A. Grimm, Principal Deputy Inspector General of the U.S. Department of Health and Human Services (HHS).

On Jan. 28, Public Citizen sent a letter to Dr. Woodcock urging her to endorse the organization’s call for an HHS Office of Inspector General (OIG) investigation of this FDA-Biogen collaboration. In a Feb. 11 response to Public Citizen, Dr. Woodcock reflexively defended the close collaborations between the FDA and the pharmaceutical industry that she had fostered over many years. She extolled the purported benefits of these collaboration while failing to acknowledge the potential for such collaborations to dangerously undermine the integrity of the agency’s review process for new drugs, as occurred in the case of her agency’s review of aducanumab.

On July 9, Dr. Woodcock belatedly asked Grimm 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.

“Public trust in the FDA has been severely damaged by the agency’s review and approval process for aducanumab,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “One first step toward restoring that trust must be an independent investigation by the HHS OIG of all aspects of the FDA’s interactions with Biogen before and after the company submitted its marketing application for the drug, including a thorough examination of the role played by Dr. Woodcock in this troubling matter.”

Such an investigation must be broad-based and determine when Dr. Woodcock first became aware of this collaboration and whether she ever specifically endorsed or facilitated it in any way, the letter said. The OIG 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 industry’s regulatory capture of the agency.

The letter to Grimm is available here.