Scope of the Position:
The Commissioner of Food and Drugs operates within the Department of Health and Human Services (HHS) and is responsible for the review, approval, and regulation of medical products, including pharmaceutical drugs, medical devices, and food supply. The Food and Drug Administration (FDA), more broadly, is responsible for ensuring a safe, sanitary, and wholesome food supply; safe and effective drugs, devices, and biological therapeutics; availability of medical countermeasures to address public health emergencies; the reduction of harm from tobacco products; and effective management of critical laboratory, office, and support facilities.
Illustrative Management Challenges:
Food Recall Inefficiency
In 2011, the HHS Inspector General found that the FDA lacked an efficient and effective food recall process.1 The audit examined why the FDA did not have appropriate authority to ensure that firms would recall certain foods, and pointed out various strategies for implementing the new Food Safety Modernization Act (FSMA) to better prevent food contamination. The FSMA gives the FDA authority to order a firm to recall certain articles of food after FDA determines that there is a reasonable probability that the food is adulterated or misbranded, and that it will cause serious adverse health consequences or death.2 In a 2016 follow-up audit, the IG concluded that the FDA does not have adequate policies and procedures to ensure that firms take prompt and effective action in initiating voluntary food recalls.
Failure to Implement Strategic Planning Efforts
In 2012, the FDA submitted a strategic integrated management plan to Congress focused on implementing increased efficiency, workforce development, and measurement processes for its three medical product centers.3 In a recent study, GAO found that the plan "does not incorporate leading practices for strategic planning or document a comprehensive strategy for the centers." In addition to these critiques, the absence of a comprehensive long-term plan for medical product oversight may hinder FDA's efforts to address emerging issues that require center collaboration, such as access to quality data.
Drug Data Management
The FDA is responsible for preventing and alleviating drug shortages. In a 2014 study, the University of Utah Drug Information Service found that the number of ongoing drug shortages between 2007 and 2013 has steadily increased. According to a GAO study, the agency found "shortcomings in [the FDA's] management of drug shortage data that are inconsistent with internal control standards."4 The FDA has also failed to conduct routine studies to identify and analyze drug shortage risks. In a recent drug safety study, the GAO found that "FDA lacks reliable, readily accessible data on tracked safety issues and postmarket studies needed to meet certain postmarket safety reporting responsibilities and to conduct systematic oversight."5
1Review of the Food and Drug Administration's Monitoring of Imported Food Recalls; www.oig.hhs.gov; June 21, 2011.
2Early Alert: The Food and Drug Administration Does Not Have an Efficient and Effective Food Recall Initiation Process; www.oig.hhs.gov; June 8, 2016.
3Food and Drug Administration: Comprehensive Strategic Planning Needed to Enhance Coordination between Medical Product Centers; www.gao.gov; May 16,
4Drug Shortages: Public Health Threat Continues, Despite Efforts to Help Ensure Product Availability; www.gao.gov; February, 10, 2014.
5Drug Safety: FDA Expedites Many Applications, but Data for Postapproval Oversight Need Improvement; www.gao.gov; December 15, 2015.
Almost all FDA Commissioners hold medical degrees and have either practiced medicine or served as a medical scientist for a research or academic organization. Given that the Commissioner regularly deals with food-borne illnesses and other health-related issues, a background in medicine appears to be a minimum qualification for this position.
Robert Califf (2016-present): Califf previously served as Deputy Commissioner for Medical Products and Tobacco for the FDA. Prior to his tenure with the FDA, he worked as a professor of medicine and Vice Chancellor for Clinical and Translational Research at Duke University. Califf also worked as the Director of the Duke Translational Medicine Institute and was a founding director of the Clinical Research Institute. He previously served as a principal investigator for Duke's Clinical and Translational Science Award and coordinated a public-private partnership between the FDA and Duke, called the Clinical Trials Transformation Initiative. Califf received his MD from Duke University School of Medicine.
Stephen Ostroff (Acting) (2015-2016): Ostroff currently serves as Deputy Commissioner for the FDA. Prior to his time as Acting Commissioner, Ostroff served as the FDA's Chief Scientist. Ostroff also worked as Chief Medical Officer in the Center for Food Safety and Applied Nutrition and Senior Public Health Advisor. He was previously the Deputy Director of the National Center for Infectious Diseases at the Centers for Disease Control and Prevention. Ostroff received his MD from the University Of Pennsylvania School Of Medicine.
Margaret A. Hamburg (2009-2015): Hamburg currently works as Foreign Secretary for the Institute of Medicine. Prior to her time as Commissioner, Hamburg worked at the Nuclear Threat Initiative. She joined HHS in 1997 as Assistant Secretary for Policy and Evaluation. Hamburg previously served as Commissioner of the New York City Department of Health and Mental Hygiene.. She received her MD from Harvard Medical School.
Andrew C. von Eschenbach (2006-2009): He currently serves as the President of Samaritan Health Initiatives. Prior to his career with HHS, von Eschenbach was the Director of the National Cancer Institute. He previously worked as Executive Vice President and Chief Academic Officer at the University of Texas MD Anderson Cancer Center. He earned his MD from Georgetown University School of Medicine.
Lester M. Crawford (2005): Prior to his appointment as Commissioner, Crawford served as Chair of the Department of Physiology-Pharmacology at the University of Georgia. He also worked as the Administrator of the Food Safety and Inspection Service and as Deputy Commissioner of the FDA. Crawford previously served as Director of the Center for Food and Nutrition Policy at Georgetown University and at Virginia Tech. He earned his DVM from Auburn University and PhD in pharmacology.
Mark B. McClellan (2002-2004): McClellan currently serves as the Director of the Robert J. Margolis, MD, Center for Health Policy at Duke University. Prior to his appointment with the FDA, McClellan held numerous positions at Stanford University, including Associate Professor of Economics, Associate Professor of Medicine, practicing internist, and Director on Health Outcomes Research. He previously served as Deputy Assistant Secretary of the Treasury for Economic Policy and was a member of the President's Council of Economic Advisors. McClellan worked as a White House Senior Policy Director for healthcare and related economic issues in the George W. Bush Administration. He received his MD and holds a PhD in economics.
Jane E. Henney (1998-2001): Henney most recently served as Home Secretary for the Institute of Medicine. Preceding her appointment as Commissioner, Henney served as the Vice President of the University of New Mexico Health Sciences. She previously served as Deputy Commissioner for Operations at the FDA and Deputy Director of the National Cancer Institute. She has held academic positions at the University of Kansas, including Vice Chancellor for Health Programs and Policy and Acting Director of the Mid America Cancer Center. For two years she worked as the school's Interim Dean for the School of Medicine. Henney also served as President of the United States Pharmacopeial Convention. She earned her MD from the Indiana University School of Medicine.
David A. Kessler (1990-1997): Kessler most recently served as the Dean of the University of California San Francisco School of Medicine. He previously worked as a consultant with the U.S. Senate Committee on Labor and Human Resources and as a Special Assistant to the President of Montefiore Medical Center in New York. He also served as Medical Director of the Hospital of the Albert Einstein College of Medicine. Kessler received his MD from Harvard University.