FDA, NIH Establish Regulatory Science Program for Tobacco

SILVER SPRING, Md. -- As part of an ongoing interagency partnership, the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) are awarding financing to create 14 Tobacco Centers of Regulatory Science (TCORS).

As the 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, and administered by three NIH institutes -- the National Cancer Institute, the National Institute on Drug Abuse, and the National Heart, Lung and Blood Institute.

In fiscal year 2013, the partnership has doled out $53 million to fund tobacco-related research.

"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. "The FDA is committed to a science-based approach that addresses the complex public health issues raised by tobacco product regulation."

The TCORS program brings together investigators from across the country to aid in the development and evaluation of tobacco product regulations. Each TCORS application identifies 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, according to the FDA.

"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. "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."

New research from TCORS will help inform and assess the impact of FDA's prior, ongoing and future tobacco regulatory activities implemented by CTP under the direction of Mitch Zeller. In addition, 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 program has the potential to award more than $273 million over the next five years. Funding may not exceed $4 million per year per center. An investigator can request a project period of up to five years.

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