The University of Texas School of Public Health has received $20 million in funding from the United States Food and Drug Administration (FDA) and the National Institutes of Health (NIH) as part of an ongoing interagency partnership. The UT School of Public Health Austin Regional Campus, part of The University of Texas Health Science Center at Houston (UTHealth), is one of 14 Tobacco Centers of Regulatory Science (TCORS), made up of scientists with a broad range of expertise (e.g., epidemiology, economics, toxicology, addictions, and marketing), that are receiving a total of up to $53 million for tobacco-related research in fiscal year 2013.
As a 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 and train the next generation of tobacco regulatory scientists.
The TCORS are expected to demonstrate research excellence and leadership in tobacco regulatory science that will contribute to the science base that FDA will use to develop meaningful product regulation, which will in turn reduce the toll of tobacco-related disease, disability, and death in the United States. Essential elements of the TCORS include at least three theoretically grounded, strong research projects with an integrative theme; an Administrative Core and other cores as needed; the ability to conduct developmental/pilot and time-sensitive research; and a program for career development and training.
Despite decades of work to reduce tobacco use in the United States, it continues to be the leading cause of preventable death and disease. As 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 the FDA, TCORS will be coordinated by NIH’s Office of Disease Prevention (ODP), 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.
A major project of the Office of Disease Prevention, says Dr. Murray, has been development of a strategic plan to guide the work of the Office for the next 5 years, from 2014 to 2018, gathering input from interested parties across the NIH, other federal agencies, academia, the nonprofit community, and the public.
As the strategic plan develops, the ODP is busy with existing programs and developing several new ones. The largest new program, Dr. Murray notes, is the Tobacco Regulatory Science Program (TRSP), which coordinates the trans-NIH effort with the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products to conduct research to support the FDA’s regulatory authority over tobacco products. The TRSP was created after the passage of the 2009 Family Smoking Prevention and Control Act, which gave the FDA authority to regulate tobacco products. These are new dollars for tobacco research, focused on regulatory science, and complementary to the existing tobacco research at the NIH.
“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,” says 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.
Located in the NIH Office of Disease Prevention (ODP), the Tobacco Regulatory Science Program (TRSP) coordinates the trans-NIH collaborative effort with the Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) to conduct research to support its regulatory activities over tobacco products.
With the passage of the 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), the FDA acquired the authority to regulate the manufacture, marketing, and distribution of tobacco products in order to protect public health. Within the framework of the Tobacco Control Act, the NIH and FDA formed an interagency partnership to foster tobacco regulatory research. The NIH has the infrastructure for the solicitation, review, and management of research, and several NIH Institutes and Centers have long supported tobacco-related research as part of their missions. The FDA has expertise in tobacco regulatory science and the authority and resources to support research responsive to FDA’s regulatory authority. NIH biomedical, behavioral and social sciences research supported via funding from FDA will provide the scientific evidence needed to better inform FDA’s regulatory authorities.
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 United States, smoking still accounts for one in five deaths each year, which is far too many,” says NIH Director Francis S. Collins, M.D., Ph.D., in a UTH release. “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 uslts, a collaboration including The University of Texas at Austin and The University of Texas MD Anderson Center. Adjunct Professor and regional dean of the UT School of Public Health Austin Regional Campus and The Rockwell Distinguished Chair in Society and Health Cheryl L. Perry, Ph.D, is principal investigator and director of the Center. The funding that the School of Public Health received will establish the Tobacco Center of Regulatory Science on Youth and Young Adults in Society.
“Nearly all first tobacco use occurs by age 18, with 1 out of 5 high school seniors still smoking cigarettes,” says Dr. Perry. “It is excellent that the FDA and NIH have funded Centers that will get to fundamental issues around the marketing of tobacco products. This research means that future regulations will be based in scientific fact.” Dr. Perry worked on the 2012 Surgeon General’s Report: Preventing Tobacco Use Among Young People — an update of the 1994 Report, “Preventing Tobacco Use Among Young People.” The new report provides more of a global perspective on prevention as well as a more comprehensive look at the literature on the link between tobacco company marketing practices and youth tobacco use.
“The overall goal is to create a program of research and training that focuses on tobacco use among young people. The research includes surveillance of adolescents and young adults in Texas, and of marketing activities of the tobacco companies. We are focusing on Texas because 1 out of 10 children in the United States live in Texas, and Texas is the No. 1 recipient of tobacco industry marketing among all states,” says Roberta Ness, M.D., M.P.H, dean of the School of Public Health. “The Center will inform the FDA with timely data on youth and young adults, so that future regulations will be based on this science, with the outcome of future generations of healthier young people.”
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 toxicity and carcinogenicity
Adverse health consequences
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 other 13 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
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: Center for Tobacco Products
Tobacco Centers of Regulatory Science (TCORS):
NIH: Office of Disease Prevention
NIH: Tobacco Regulatory Science Program
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.
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:
Sources: University of Texas School of Public Health, NIH