REGULATORY AFFAIRS

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FDA and NIH Create First-of-Kind Tobacco Centers of Regulatory Science Research

 

Despite decades of work to reduce tobacco use in the United States, it continues to be the leading cause of preventable death and disease.

 

The FDA and the 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). This new, first-of-its-kind regulatory science tobacco program, 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.

 

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.

 

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. 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:

 

1. Diversity of tobacco products
2. Reducing addiction
3. Reducing toxicity and carcinogenicity
4. Adverse health consequences
5. Communications
6. Marketing of tobacco products
7. Economics and policies

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