Operational Evaluation of
FDA’s Tobacco Program
On December 19, 2022, the Independent Expert Panel submitted its report on the Operational Evaluation of Certain Components of FDA's Tobacco Program to FDA Commissioner Dr. Robert Califf. The evaluation and report were facilitated by the Reagan-Udall Foundation at Dr. Califf’s request.
The tobacco operational evaluation began September 21, 2022. The evaluation addressed 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 did not address tobacco policy issues, which were outside the scope of this evaluation.
The five-member Independent Expert Panel charged with generating recommendations of FDA’s tobacco program included 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.
Independent Expert Panel Virtual Public Meetings
On October 21, 24, and 25, the Foundation facilitated virtual meetings of the Independent Expert Panel on tobacco. The Panel heard from invited stakeholders on specific Center for Tobacco Products operations: regulations and guidance, application review, compliance and enforcement, and communication with the public and other stakeholders. The panel did not address tobacco policy issues, which are outside the scope of this evaluation.