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On Feb. 27, 2023, the Food and Drug Administration (FDA) announced in an internal email to agency staff that Dr. Billy Dunn — the director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research (CDER) — was leaving the agency.[1] Dunn’s office was responsible for the review and accelerated approval of drugmaker Biogen’s aducanumab (ADUHELM) for treatment of Alzheimer’s disease.
Notably, in June 2021, Public Citizen’s Health Research Group had urged U.S....
On Feb. 27, 2023, the Food and Drug Administration (FDA) announced in an internal email to agency staff that Dr. Billy Dunn — the director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research (CDER) — was leaving the agency.[1] Dunn’s office was responsible for the review and accelerated approval of drugmaker Biogen’s aducanumab (ADUHELM) for treatment of Alzheimer’s disease.
Notably, in June 2021, Public Citizen’s Health Research Group had urged U.S. Secretary of Health and Human Services Xavier Becerra to immediately request the resignations of Dunn and then-Acting FDA Commissioner Janet Woodcock and CDER Director Patrizia Cavazzoni.[2],[3]
We had sought such action because of the FDA’s indefensible decision to approve aducanumab despite the lack of evidence that the drug provides any meaningful clinical benefit to Alzheimer’s disease patients but definitive data showing that the drug can cause potentially serious brain injury in a substantial number of patients, and because of evidence of an unprecedented and inappropriately close collaboration between Biogen and the FDA before and after the submission of the company’s marketing application for the drug that dangerously compromised the integrity of the FDA’s review.
The central role played by Dunn in the FDA’s inappropriately close collaboration with Biogen was highlighted in a detailed exposé published by STAT on June 29, 2021. This collaboration reportedly began with an “off-the-books” May 2019 meeting between Dunn and then-Biogen Chief Scientist Al Sandrock.[4]
According to STAT, after a subsequent June 14, 2019, meeting between Biogen and FDA Office of Neuroscience staff, the company and the agency “established a ‘working group collaboration’ consisting of company employees and agency review staff. The group met or communicated almost daily in June, July, and August of 2019, working to collect and analyze [aducanumab] data for inclusion in the planned marketing submission.”[5]
Details of this troubling collaboration were confirmed in a report issued by the U.S. House of Representatives Committees on Oversight and Reform and on Energy and Commerce on Dec. 29, 2022, that was discussed in my March column.[6]
The FDA’s decision to approve aducanumab was a disastrous blow to the agency’s credibility. The departure of Dunn from the agency is a welcome, but long overdue, development. But other senior FDA officials, including Woodcock and Cavazzoni, who fostered the permissive culture that encouraged inappropriately close agency collaboration with Big Pharma, also must leave the FDA to restore public confidence in the agency.
(Note to readers: This will be the last issue of Worst Pills, Best Pills News for which I will be the editor. The new editor of our newsletter will be Dr. Robert Steinbrook, who is highly qualified to assume this role and will introduce himself to readers in next month’s issue.)
References
[1] Feuerstein A, Garde D. FDA’s Billy Dunn, key figure in approval of Aduhelm, to leave agency. STAT. February 27, 2023. https://www.statnews.com/2023/02/27/fda-billy-dunn-leaving/. Accessed March 3, 2023.
[2] Public Citizen. Letter to Xavier Becerra regarding the FDA’s reckless decision to approve aducanumab for treating Alzheimer’s disease. June 16, 2021. https://www.citizen.org/wp-content/uploads/2590.pdf. Accessed March 3, 2023.
[3] Public Citizen. Letter to Xavier Becerra regarding the FDA’s reckless decision to approve aducanumab for treating Alzheimer’s disease. June 30, 2021. https://www.citizen.org/wp-content/uploads/2591.pdf. Accessed March 3, 2023.
[4] Feuerstein A, Herper M, Garde D. Inside ‘Project Onyx’: How Biogen used an FDA back channel to win approval of its polarizing Alzheimer’s drug. June 29, 2021. STAT. https://www.statnews.com/2021/06/29/biogen-fda-alzheimers-drug-approval-aduhelm-project-onyx/. Accessed March 3, 2023.
[5] Ibid.
[6] U.S. House of Representatives. Committee on Oversight and Reform and Committee on Energy and Commerce. The High Price of Aduhelm’s Approval: An Investigation into FDA’s Atypical Review Process and Biogen’s Aggressive Launch Plans. December 2022. https://democrats-energycommerce.house.gov/sites/democrats.energycommerce.house.gov/files/documents/Final%20Aduhelm%20Report_12.29.22.pdf. Accessed March 3, 2023.
