Reagan-Udall Foundation names members of FDA review panel

U.S – The Reagan-Udall Foundation, an independent not-for-profit organization created by Congress, has named a panel of five independent experts who will assess the Food and Drug Administration’s (FDA) human foods program.

Also known as the FDA Foundation, the organization through stakeholder involvement and public-private collaborations that foster innovation, encourages the use of real-world evidence, and identifies contemporary tools and policies to keep pace with today’s quickly evolving science.

The panel’s Chair, Dr. Jane Henney, a former FDA commissioner, was chosen last month and will be joined by Francisco Diez-Gonzalez, James Jones, Barbara Kowalcyk, Shiriki Kumanyika, and John Taylor.

“This team brings the right combination of FDA and other government experience along with deep subject matter expertise and first-hand systems and operations knowledge. We appreciate their commitment to developing actionable recommendations to help improve FDA’s human foods program,” said Jane E. Henney, MD.

Henney served as FDA Commissioner from January 1999-2001 after previously serving as the Agency’s Deputy Commissioner for Operations and holding several academic leadership positions.

She also held multiple posts, including Deputy Director, at the National Cancer Institute of the National Institutes of Health.

Focusing on structure, leadership, authorities, resources, and culture, the assessors hope to make recommendations that will enable FDA to fulfill its regulatory obligations, improve cooperation with state and local authorities, and safeguard the nation’s food supply in the long run.

The review began yesterday on September 8 and will end 60 business days later, on December 6, with a report delivered to Dr. Robert Califf, Commissioner of Food and Drugs at the FDA.

Researchers, former regulators, and process improvement experts with disciplinary competence and experience in epidemiology, food science and safety, microbiology, nutrition, and regulatory operations make up the Independent Expert Panel, which is tasked with producing the report.

Panelists profile

Francisco Diez-Gonzalez, PhD, a food safety microbiologist, is Director of the Center for Food Safety and a Professor in the Department of Food Science and Technology at the University of Georgia’s College of Agricultural and Environmental Sciences.

He is a member of the USDA’s National Advisory Committee on Microbiological Criteria for Foods and carries out research on foodborne diseases, reports Food Safety News.

James Jones, who spent 30 years working for the United States, is the President of JJones Environmental Agency for Environmental Protection. His tenure at the EPA included five years as the Assistant Administrator.

Focusing on structure, leadership, authorities, resources, and culture, the assessors hope to make recommendations that will enable FDA to fulfill its regulatory obligations, improve cooperation with state and local authorities, and safeguard the nation’s food supply in the long run.

He oversaw the agency’s efforts to significantly reduce the amount of pesticides in food, to manage a backlog of pesticide registrations and tolerances that had been building for years, and to lead the Obama Administration’s efforts to reform the Toxic Substances Control Act.

Barbara Kowalcyk, PhD, is an Associate Professor of Food Safety and Public Health in the Department of Food Science and Technology at The Ohio State University’s College of Food, Agricultural, and Environmental Sciences. She also serves as the Director of the Center for Foodborne Illness Research and Prevention.

She is a reputable Epidemiologist and Biostatistician who has been on the FDA Science Board for almost ten years, where she currently serves as Chair.    

Barbara Kowalcyk, PhD, directs the Center for Foodborne Illness Research and Prevention at The Ohio State University’s College of Food, Agricultural, and Environmental Sciences and is an Associate Professor of Food Safety and Public Health in the Department of Food Science and Technology.

She has been a member of the FDA Science Board for about ten years and currently serves as Chair. She is a respected epidemiologist and biostatistician.     

Shiriki Kumanyika, PhD, MS, MPH, is a research professor in the Department of Community Health and Prevention at Drexel University’s Dornsife School of Public Health.

She currently serves as the National Academies Food and Nutrition Board chair and has used her multidisciplinary training and substantial research experience in a variety of roles.

She is also Emeritus Professor of Epidemiology at the University of Pennsylvania’s Perelman School of Medicine.

John Taylor, JD, is President and Principal, Compliance and Regulatory Affairs, at Greenleaf Health. He worked at the FDA for more than 20 years, holding positions such as Associate Commissioner for Regulatory Affairs, Counselor to the Commissioner, Acting Deputy Principal Commissioner, and Acting Deputy Commissioner for Global Regulatory Operations and Policy.

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