261423 Expanding the research base to include tobacco product regulation: Working with the FDA Center for Tobacco Products

Monday, October 29, 2012 : 8:45 AM - 9:00 AM

Cathy L. Backinger, PhD, MPH , Office of Science, FDA Center for Tobacco Products, Rockville, MD
Lucinda Miner, PhD , Office of Science, FDA Center for Tobacco Products, Rockville, MD
Ashley Ross, BA, MPH , Center for Tobacco Products, U.S. Food and Drug Administration, US Food and Drug Administration (FDA), Rockville, MD
With the passage of the Family Smoking Prevention and Tobacco Control Act in 2009, FDA was given authority to regulate the manufacture, distribution, and marketing of tobacco products. FDA established the Center for Tobacco Products (CTP) in August, 2009 to implement this new regulatory authority to reduce tobacco-related illness and death nationwide. Since its inception, the Center has recognized the importance of strengthening the existing science base to support the regulation of tobacco products. CTP's Office of Science is working to implement a focused research agenda to meet its regulatory science needs and to evaluate population and public health impact. This panel will provide an overview of the Tobacco Control Act and highlight some of the research activities of the CTP, including the new Population Assessment of Tobacco and Health (PATH) study, a national longitudinal, cohort study in collaboration with NIH; graphic health warnings for cigarette packages; and the Tobacco Products Scientific Advisory Committee (TPSAC). Discussion will include information on how FDA communicates with the research community and how the research community can communicate with the FDA. In addition, the presenters will discuss research priorities and funding plans, discuss identified gap areas where more research is needed to help inform tobacco regulation, and the mechanisms that FDA can use to support needed research.

Learning Areas:
Basic medical science applied in public health
Conduct evaluation related to programs, research, and other areas of practice
Public health biology
Public health or related research
Social and behavioral sciences

Learning Objectives:
1. Describe the Food and Drug Administration's authority to regulate tobacco products and the steps that the FDA has taken to date 2. Describe basic elements of the FDA Center for Tobacco Products Research Agenda to meet its regulatory science needs and to evaluate population and public health impact 3. Discuss identified gap areas and FDA mechanisms to support needed research 4. Describe ways in which the FDA and research community can communicate

Keywords: Tobacco Control, Research Agenda

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I am Deputy Director for Research of the Office of Science, Center for Tobacco Products, Food and Drug Administration. I am responsible identifying research gaps and developing research initiatives regarding the manufacture, marketing, and distribution of tobacco products under regulatory authority of FDA.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.