FDA and NIH create first-of-kind Tobacco Centers of Regulatory Science

Research from new program to inform potential tobacco regulatory activities

The U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH), as part of an on-going interagency partnership, have awarded a total of up to $53 million to fund tobacco-related research in fiscal year 2013 to create 14 Tobacco Centers of Regulatory Science (TCORS).

Despite decades of work to reduce tobacco use in the United States, it continues to be the leading cause of preventable death and disease. A new, first-of-its-kind regulatory science tobacco program, TCORS is designed to generate research to inform the regulation of tobacco products to protect public health. Using designated funds from FDA, TCORS will be coordinated by NIH’s Office of Disease Prevention, directed by David M. Murray, Ph.D., and administered by three NIH institutes — the National Cancer Institute, the National Institute on Drug Abuse, and the National Heart, Lung, and Blood Institute.

“For the first time, under the Family Smoking Prevention and Tobacco Control Act, the federal government, through the FDA Center for Tobacco Products (CTP), is able to bring science-based regulation to the manufacturing, marketing and distribution of tobacco products,” said FDA Commissioner Margaret A. Hamburg, M.D. “The FDA is committed to a science-based approach that addresses the complex public health issues raised by tobacco product regulation.” The agency is establishing science and research programs designed to increase understanding of the risks associated with tobacco use.

The TCORS program brings together investigators from across the country to aid in the development and evaluation of tobacco product regulations. Each TCORS application identified a targeted research goal. Taken together, the TCORS sites will increase knowledge across the full spectrum of basic and applied research on tobacco and addiction. The program also provides young investigators with training opportunities to ensure the development of the next generation of tobacco regulatory scientists.

“While we’ve made tremendous strides in reducing the use of tobacco products in the U.S., smoking still accounts for one in five deaths each year, which is far too many,” said NIH Director Francis S. Collins, M.D., Ph.D. “FDA/NIH partnerships like the Tobacco Centers of Regulatory Science keep us focused on reducing the burden and devastation of preventable disease caused by tobacco use.”

Comprised of scientists with expertise in fields including epidemiology, behavior, biology, medicine, economics, chemistry, toxicology, addictions, public health, communications, and marketing, the TCORS program is the centerpiece of the FDA/NIH collaboration to foster research relevant to tobacco regulatory science. New research from TCORS will help inform and assess the impact of FDA’s prior, ongoing and potential future tobacco regulatory activities implemented by CTP under the direction of Mitch Zeller, J.D. In addition, the TCORS investigators will have the flexibility and capacity to begin new research to address issues raised in today’s rapidly evolving tobacco marketplace.

The TCORS awards represent a significant investment in federal tobacco regulatory science, including $53 million in the first year and a potential total of more than $273 million over the next five years. TCORS funding may not exceed $4 million in total costs per year per center, and an investigator could request a project period of up to five years.

Designed to generate vital research in seven core areas, as well as ensure innovation in the field, the research supported by this initiative will provide scientific evidence within the following seven FDA tobacco-related research interest areas:

Diversity of tobacco products
Reducing addiction
Reducing toxicity and carcinogenicity
Adverse health consequences
Communications
Marketing of tobacco products
Economics and policies

TCORS proposals were selected for funding based on their scientific and technical merit as determined by NIH scientific peer review, availability of funds, and relevance of the proposed projects to program priorities.

The 14 TCORS have been awarded to:

Aruni Bhatnagar, Ph.D., and Rose M. Robertson, M.D., American Heart Association, Dallas
Pamela I. Clark, Ph.D., University of Maryland, College Park
Thomas E. Eissenberg. Ph.D., Virginia Commonwealth University, Richmond
Michael P. Eriksen, Ph.D., Georgia State University, Atlanta
Stanton A. Glantz, Ph.D., University of California-San Francisco
Stephen T. Higgins, Ph.D., University of Vermont and State Agriculture College, Burlington
Robert C. Hornik, Ph.D., and Caryn Lerman Ph.D., University of Pennsylvania, Philadelphia
Suchitra Krishnan-Sarin, Ph.D., and Stephanie S. O’Malley, Ph.D., Yale University, New Haven
Joshua E. Muscat, Ph.D., and Jonathan Foulds, Ph.D., Penn State College of Medicine/Penn State Milton S. Hershey Medical Center, Hershey
Mary Ann Pentz, Ph.D., and Jonathan Samet, M.D., University of Southern California, Los Angeles
Cheryl L. Perry, Ph.D., University of Texas Health Sciences Center, Houston
Kurt M. Ribisl, Ph.D., University of North Carolina at Chapel Hill
Peter G. Shields, M.D., and Mary Ellen Wewers, Ph.D. The Ohio State University, Columbus
Robert Tarran, Ph.D., University of North Carolina at Chapel Hill, School of Medicine

For more information:

FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

The Office of the Director, the central office at NIH, is responsible for setting policy for NIH, which includes 27 Institutes and Centers. This involves planning, managing, and coordinating the programs and activities of all NIH components. The Office of the Director also includes program offices which are responsible for stimulating specific areas of research throughout NIH. Additional information is available at http://www.nih.gov/icd/od.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.