FDA Operational Evaluation

As announced on July 19, 2022, the Reagan-Udall Foundation will facilitate, via two Independent Expert Panels, operational new SCW quoteevaluations of FDA’s human foods and tobacco programs. Each evaluation will yield a report with operational recommendations to the FDA: one for human foods and the other for tobacco. Each evaluation, and therefore report delivery, is on its own 60-business-day timeline. Both reports will be delivered to the FDA Commissioner and made available to the public.

Evaluation of FDA’s Human Foods Program

The evaluation of FDA’s Human Foods Program launched on September 8, 2022. The evaluation will focus on structure/leadership, authorities, resources, and culture, expecting to provide recommendations that would equip FDA to carry out its regulatory responsibilities, strengthen its relationships with state and local governments, and secure the nation’s food supply for the future. (The review excludes cosmetic and dietary supplement responsibilities.)

The Foundation has convened a food-focused Independent Expert Panel 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.

Jane Henney, MD, (Chair), was the 18th Commissioner of Food and Drugs serving from January 1999-2001. She previously served as the Agency’s Deputy Commissioner for Operations, and held multiple posts, including Deputy Director, at the National Cancer Institute of the National Institutes of Health.

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.

Gathering Stakeholder Input on FDA's Human Foods Program

Tell us what you think through our online Stakeholder Portal. It’s an opportunity to share your perspectives and experiences about what’s working in FDA’s human foods program, the challenges you see, and your ideas to improve program operations. Your feedback will be shared with the Independent Expert Panel charged with generating the recommendations for FDA.

On September 29-30, the Foundation facilitated a public meeting of the Independent Expert Panel on food. The Panel heard from invited stakeholders on a variety of topics to inform its review of the structure/leadership, authority, resources, and culture of FDA’s human foods program. 

Evaluation of FDA’s Tobacco Program

The tobacco operational evaluation began September 21, 2022. The evaluation will address the Center for Tobacco Products' programs for regulations and guidance, application review, compliance and enforcement, and communication with the public and other stakeholders. The panel will not address tobacco policy issues, which are outside the scope of this evaluation.

The five-member Independent Expert Panel charged with generating recommendations of FDA’s tobacco program includes former FDA leaders and regulatory strategists as well as process improvement specialists:

Lauren Silvis, JD, spent two years as Chief of Staff at FDA following her time as the Deputy Center Director for Policy in FDA’s Center for Devices and Radiological Health. Recently, she served as Senior Advisor on COVID-19 Response for the U.S. Department of Health and Human Services.

Jane Axelrad, JD, spent 25 years at FDA as the Associate Director for Policy at FDA’s Center for Drug Evaluation and Research. She stood up the Center’s Office of Regulatory Policy, providing strategic policy advice to the Center Director and other senior staff.   Before retiring from FDA, she was the Agency lead responsible for developing a comprehensive program for the oversight of the evolving drug compounding industry. Today she is principal at Axelrad Solutions LLC. 

Keith Flanagan, JD, stood up two new offices within FDA’s Center for Drug Evaluation and Research: the Office of New Drug Policy and the Office of Generic Drug Policy. Previously, as Senior Health Counsel to the U.S. Senate Health, Education, Labor & Pensions (HELP) Committee, he co-authored numerous FDA reform laws. He is the owner of Flanagan Strategies, LLC.

Charlene Frizzera is President and Co-founder of CF Health Advisors following three decades at the Centers for Medicare and Medicaid Services, including roles as the Acting Administrator and Chief Operating Officer. She led the Agency’s policy and operational aspects, including budget, information technology and systems, human resources, contracting, administration, and program integrity.

Alberto Gutierrez, PhD, a Partner at NDA Partners, a ProPharma Group Company, spent 25 years at FDA gaining expertise in preclinical and clinical testing, premarket notifications of devices, applications for approval, and post-marketing surveillance and compliance. He retired in 2017 as the Director of In Vitro Diagnostics and Radiological Health in the Center for Devices and Radiological Health.

Gathering Stakeholder Input on FDA's Tobacco Operations

Watch this page for details on upcoming public meetings of the Independent Review Panel on tobacco and the opening of a web-based portal for public feedback on FDA’s tobacco operations.


Independent Expert Panel Announced to Review FDA’s Tobacco Program

Experts Announced for Review of FDA Human Foods Program

Henney, Silvis Tapped as Lead Evaluators

The Reagan-Udall Foundation for the FDA is an independent 501(c)(3) created by Congress to advance the mission of the U.S. Food and Drug Administration. Read more about us.

 

This activity is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of an award of $90,000 in federal funds (100% of the project). The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA, HHS, or the U.S. Government