Author Biographies and Disclosures

“Seven Former FDA Commissioners: The FDA Should Be an Independent Federal Agency.” Health Affairs (January 2019; 38:1)

A Health Affairs article published by seven former Commissioners of the US Food and Drug Administration (FDA) recommended that the FDA be moved out of the US Department of Health and Human Services and reconfigured as an independent agency. A more detailed report of the evidence gathered to support their recommendation is available on the Aspen Institute’s Health, Medicine and Society Program website, which convened the commissioners to examine the issue.

The commissioners attest that they received no financial support for participating in this project and that they have no conflicts of interest regarding the conclusions and recommendations contained in the article. Many of the commissioners have financial relationships in the private sector, including with the pharmaceutical industry, and serve on various corporate and professional association boards. Author bios and further disclosures are provided below:

Robert M. Califf, MD, is the Donald F. Fortin, M.D. Professor of Cardiology at the Duke University School of Medicine, in Durham, North Carolina. He is employed by Verily Life Sciences, an Alphabet Company, which is developing products regulated by the FDA; serves on the board of Cytokinetics, Inc; chairs the board of the People Centered Research Foundation; and consults with companies that make medical products. Dr. Califf was FDA commissioner from 2016 to 2017.

Margaret Hamburg, MD, is foreign secretary of the National Academy of Medicine and president of the American Association for the Advancement of Science, in Washington, D.C. Beginning in 2019, she will serve on the board of Alnylam Pharmaceuticals, Inc. Dr. Hamburg was FDA commissioner from 2009 to 2015.

Jane E. Henney, MD, is home secretary of the National Academy of Medicine in Washington D.C. She serves on the board of AmerisourceBergen Corporation and The China Medical Board, and served on Cigna Corporation’s board until April 2018. Dr. Henney was FDA commissioner from 1998 to 2001.

David A. Kessler, MD, JD, is a professor of pediatrics and of epidemiology and biostatistics at the University of California San Francisco. He serves on the boards of Immucor and the Center for Science and the Public Interest and has previously served on other corporate and nonprofit boards. He also advises food companies and has testified in litigation involving FDA-regulated products. Dr. Kessler was FDA commissioner from 1990 to 1997.

Mark McClellan, MD, PhD, is director of the Duke-Robert J. Margolis Center for Health Policy and the Robert J. Margolis Professor of Business, Medicine, and Policy at Duke University, in Durham, North Carolina and Washington, DC. He an independent board member for Alignment Health Care, Cigna, and Johnson & Johnson; co-chairs the Accountable Care Learning Collaborative and the Guiding Committee for the Health Care Payment Learning and Action Network; and serves as an advisor for Cota, MITRE, and the National Institute for Health Care Management. Dr. McClellan was FDA commissioner from 2002 to 2004.

Andrew C. von Eschenbach, MD, is president of Samaritan Health Initiatives, in Montgomery, Texas. He is an advisor to various entities engaged in health care; a senior fellow at the Milken Institute; a senior advisor at the Bipartisan Policy Center; and a recent appointee to the boards of the Reagan Udall Foundation of the FDA and Bausch Health Companies Inc. He also serves as a director of Celularity, COTA, Banyan Biomarkers, Histosonics, and Innocrin and on the boards of the Prostate Cancer Foundation, the Focused Ultrsound Foundation , and the Houston Methodist Research Institute. Dr. von Eschenbach was FDA commissioner from 2006 to 2009.

Frank Young, MD, is executive vice president of clinical and regulatory affairs at TissueTech, Inc. & Subsidiaries in Miami, Florida. Dr. Young was FDA commissioner from 1984 to 1989.