Henney, Silvis Tapped as Lead Evaluators

Review to focus on modernizing FDA structure for the future

(August 17, 2022) The Reagan-Udall Foundation announced today that former Commissioner of Food and Drugs Jane E. Henney, MD, and former FDA Chief of Staff Lauren Silvis, JD, will lead the operational evaluation of the Food and Drug Administration’s human foods and tobacco work. Henney will lead the evaluation team focused on human foods while Silvis will lead the team focused on tobacco. The project was announced by Commissioner Robert Califf late last month. 

“We are excited to work with both Dr. Henney and Ms. Silvis,” said Susan C. Winckler, RPh, Esq., CEO of the Reagan-Udall Foundation. “Each has direct experience with the work of FDA along with specialized insight into the structure and processes needed as FDA continues to modernize its approach ahead of future demands.” 

Winckler said the Foundation’s scope for each evaluation varies based on the needs of the programs. For human foods, the evaluators 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.) 

For tobacco, the evaluators will focus on recommendations to help modernize the structure and organization of the center and improve its regulatory processes and functions, including premarket review, and compliance and enforcement efforts. 

Separate reports on each topic will be submitted to FDA and made public. Once each 60-business-day evaluation is launched, Henney and Silvis will work with additional external evaluators who bring relevant expertise from both inside and outside of federal government. The evaluators will also have access to multiple subject matter experts. 

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. 

Ms. Silvis 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.

About the Reagan-Udall Foundation for the FDA

The Reagan-Udall Foundation for the FDA (FDA Foundation) is an independent 501(c)(3) created by Congress to advance regulatory science to help the U.S. Food and Drug Administration accomplish its mission. The FDA Foundation works to improve health and safety through stakeholder engagement and public-private partnerships that facilitate innovation, foster the use of real-world evidence, and identify modern tools and policies to keep pace with today’s rapidly evolving science.

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