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FDA review panel picked to help fix FDA

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The Reagan-Udall Foundation today announced five members of an Independent Expert Panel who will conduct the operational evaluation of the Food and Drug Administration’s human foods program. Dr. Jane Henney, former FDA Commissioner, was named as Chair of the panel last month. Joining Henney are 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,” said Jane E. Henney, MD, Chair of the Independent Expert Panel. “We appreciate their commitment to developing actionable recommendations to help improve FDA’s human foods program.”

The review is set to officially launch on September 8, 2022, culminating 60-business-days later (December 6, 2022) in a report to Dr. Robert Califf, Commissioner of Food and Drugs, at FDA.

The Independent Expert Panel, charged with generating the report, is comprised of researchers, former regulators, and process improvement specialists with disciplinary expertise and experience in epidemiology, food science and safety, microbiology, nutrition, and regulatory operations.

  • 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 conducts research aimed to control foodborne pathogens and is a member of the USDA’s National Advisory Committee on Microbiological Criteria for Foods.
  • James Jones is President of JJones Environmental, following a 30-year career at the U.S. Environmental Protection Agency. His posts at EPA included five years as the Assistant Administrator, and his accomplishments include leading the agency’s effort to significantly reduce pesticides in food and navigating a years-long backlog of pesticide registrations and tolerances as well as leading the Obama Administration’s efforts to reform the Toxic Substances Control Act.
  • 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 Associate Professor of Food Safety and Public Health in the Department of Food Science and Technology. She is a well-respected epidemiologist and biostatistician, and a nearly ten-year member of the FDA Science Board, which she currently chairs.
  • Shiriki Kumanyika, PhD, MS, MPH, is Research Professor in the Department of Community Health and Prevention at Drexel University’s Dornsife School of Public Health. She has applied her interdisciplinary background and extensive research experience in numerous roles, and currently chairs the National Academies Food and Nutrition Board. She is also Emeritus Professor of Epidemiology at the Perelman School of Medicine, University of Pennsylvania.
  • John Taylor, JD, is President and Principal, Compliance and Regulatory Affairs, at Greenleaf Health. He spent more than 20 years at FDA, holding posts that included Counselor to the Commissioner, Acting Deputy Principal Commissioner, Acting Deputy Commissioner for Global Regulatory Operations and Policy, and Associate Commissioner for Regulatory Affairs.

The Independent Expert Panel will focus on structure/leadership, authority, resources, and culture as it develops recommendations to equip FDA to better carry out its regulatory responsibilities, strengthen its relationships with state and local governments, and secure the nation’s food supply for the future.

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