Seven Former FDA Commissioners: The FDA Should Be An Independent Federal Agency

Robert M Califf; Margaret Hamburg; Jane E Henney; David A Kessler; Mark McClellan; Andrew C von Eschenbach; Frank Young

doi:10.1377/hlthaff.2018.05185

Seven Former FDA Commissioners: The FDA Should Be An Independent Federal Agency

Health Aff (Millwood). 2019 Jan;38(1):84-86. doi: 10.1377/hlthaff.2018.05185.

Authors

Robert M Califf¹, Margaret Hamburg², Jane E Henney³, David A Kessler⁴, Mark McClellan⁵, Andrew C von Eschenbach⁶, Frank Young⁷

Affiliations

¹ Robert M. Califf is the Donald F. Fortin, M.D. Professor of Cardiology at the Duke University School of Medicine, in Durham, North Carolina. Dr. Califf was FDA commissioner from 2016 to 2017.
² Margaret Hamburg is foreign secretary of the National Academy of Medicine and president of the American Association for the Advancement of Science, in Washington, D.C. Dr. Hamburg was FDA commissioner from 2009 to 2015.
³ Jane E. Henney is home secretary of the National Academy of Medicine, in Washington, D.C. Dr. Henney was FDA commissioner from 1998 to 2001.
⁴ David A. Kessler is a professor of pediatrics and of epidemiology and biostatistics at the University of California San Francisco. Dr. Kessler was FDA commissioner from 1990 to 1997.
⁵ Mark McClellan 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, D.C. Dr. McClellan was FDA commissioner from 2002 to 2004.
⁶ Andrew C. von Eschenbach is president of Samaritan Health Initiatives, in Montgomery, Texas. Dr. von Eschenbach was FDA commissioner from 2006 to 2009.
⁷ Frank Young is executive vice president of clinical and regulatory affairs at TissueTech, Inc., and Subsidiaries, in Miami, Florida. Dr. Young was FDA commissioner from 1984 to 1989.

PMID: 30615515
DOI: 10.1377/hlthaff.2018.05185

Abstract

Seven former commissioners of the Food and Drug Administration (FDA) from both sides of the political aisle recommend that the FDA be moved out of the Department of Health and Human Services and reconfigured as an independent federal agency. We believe that such a reengineering would promote reliance on consistent science-based regulation and ensure that the American public has access to the best that science and industry can offer.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Biomedical Research*
Decision Making*
Humans
United States
United States Dept. of Health and Human Services / organization & administration*
United States Food and Drug Administration / legislation & jurisprudence
United States Food and Drug Administration / organization & administration*