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The US Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have formed a partnership to support tobacco-related research that will inform the FDA in its efforts to regulate tobacco products.

The centerpiece of that partnership is the establishment of 14 Tobacco Centers of Regulatory Science (TCORS) for tobacco-related research, and the FDA and the NIH have awarded $53 million in fiscal year 2013 to fund these programs. The grant awards were announced in September 2013 (see the list of grantees below). “The centers have the capacity to develop new research and address what we see as a rapidly changing tobacco marketplace,” says Helen Meissner, PhD, director of the NIH's Tobacco Regulatory Science Program.

She notes that although the FDA is funding the initiative, the NIH is providing the infrastructure to solicit, review, and manage the large research portfolio.

Under the Family Smoking Prevention and Tobacco Control Act, which was signed into law in 2009 and is more commonly known as the Tobacco Control Act, the FDA Center for Tobacco Products is able to bring science-based regulation to the manufacturing, marketing, and distribution of tobacco products. To do so, the agency will require help from TCORS and other research efforts to better understand the complex public health issues involved to support proposed regulations, says FDA Commissioner Margaret A. Hamburg, MD.

Multidisciplinary and Collaborative

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The goal of the TCORS program is to bring together researchers from around the country across the full spectrum of basic and applied research on tobacco and addiction. The scientists involved come from a broad range of fields including epidemiology, biology, medicine, economics, chemistry, toxicology, addictions, public health, communications, and marketing.

Each center identified a targeted research goal. The program also will provide training opportunities to young investigators to ensure the growth and development of the regulation science field.

The TCORS program has the potential to fund more than $273 million in research over the next 5 years, and the research will address 7 core areas:

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

The FDA/NIH partnership brings the expertise of both centers to bear in addressing the tobacco problem, Dr. Meissner says, adding that the agencies work together on other tobacco-related research in addition to TCORS. While the NIH coordinates the grant application and management process, the FDA ultimately has the final say on which research will be funded.

“With this partnership, there's a conduit for scientific evidence to be used in setting national health policy,” she says. “The NIH funds lots of research, some of which never makes it into clinical and public health policy. Here, we have a program that's set up for that.”

The 2 agencies meet regularly to discuss TCORS and other joint regulatory science projects, and TCORS will hold investigator meetings twice annually. “Our scientists will be at the meetings to make sure the researchers understand our viewpoint from a regulatory perspective and to look at their progress,” says Cathy Backinger, PhD, MPH, deputy director for research science at the FDA Center for Tobacco Products.

Both Drs. Meissner and Backinger agree that there is “much more work to do” in terms of tobacco regulatory science. “We've made enormous strides in morbidity and mortality related to tobacco since the first US Surgeon General's Report warning of the hazards of tobacco was released in 1964,” Dr. Backinger says. “But in the last 10 to 15 years, our progress has stalled.”

At the same time, she says that the Tobacco Control Act provides an opportunity. “For the first time, tobacco manufacturers have to submit applications to the FDA in order to receive authorization to market their products,” she says. “If they want to say their product has less risk of causing a disease, they have to give us the data to evaluate before it can be marketed.”

Ohio Program to Address Usage, Marketing

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  3. Ohio Program to Address Usage, Marketing

Among the TCORS award recipients is The Ohio State University in Columbus, which received $18.7 million for its research into the study of tobacco use patterns, industry marketing practices, and public perceptions. Eighteen scientists from 6 different colleges will conduct research as part of the new Ohio State University center. “The whole concept of regulatory science is very interesting to population scientists,” says Peter Shields, MD, coleader of the new center and deputy director of The Ohio State University Comprehensive Cancer Center. “We're interested in affecting behaviors and interventions for cancer, and that's really challenging.”

Dr. Shields, a specialist in developing biomarkers to assess lifestyle-related cancer risk factors, says the Ohio-based TCORS will examine the use of multiple tobacco products among adolescents and adults, including the risk factors that predict use, exposure to toxic chemicals, why smokers choose certain products over others, and genetic predispositions for addiction. Additional research will analyze purchasing behavior and marketing practices in various environments and decision-making factors that lead people to use tobacco in the first place.

Dr. Meissner adds that the goal of TCORS is to create a truly collaborative, multidisciplinary research program. “We have a couple of centers that are working on biomarkers, and we hope they will learn from one another and work on shared areas of interest,” she says. “We also have some centers that are working on health communications. They may develop some common measures to do some comparisons across sites.”

With this partnership, there's a conduit for scientific evidence to be used in setting national health policy. –Helen Meissner, PhD