IMPORTANT RESEARCH OPPORTUNITIES RELATED TO FDA REGULATORY AUTHORITY OVER TOBACCO PRODUCTS
Thursday, August 25, 2011
Posted by: Natalia Gromov
The recent FDA announcement about placing the 1-800-QUIT-NOW number (ie, the toll-free number that connects callers with their state quitlines) on graphic health warnings provides a unique opportunity to study the impact of these warnings. The new warnings are scheduled to begin appearing on cigarette packs in retail outlets in September 2012, just 13 months from now. To facilitate the development of grant proposals related to the new health warnings, the North American Quitline Consortium (NAQC) will be making resources available to researchers to help support development of proposals for potential funding from NIH and TRDRP.
The research opportunities and NAQC resources are described below:
1. Research Opportunities at NIH: FDA has authority to fund research proposals that relate to the Family Smoking Prevention and Tobacco Control Act (FSPTCA), such as proposals to study aspects of graphic health warnings, and other topics relevant to FDA regulation of tobacco products. FDA must assure its funds are relevant to the FSPTCA, and that they directly advance a specific regulatory objective. Research questions bridging the fields of tobacco control, behavior change, communications and marketing, economics, and others may be of interest to FDA. Additional areas of interest may include consumer perception and tobacco use behaviors of other tobacco products such as smokeless tobacco, as well as understanding consumers' perceptions of the implications of FDA's regulatory authority over tobacco products. The 1-800-QUIT-NOW number will be included on the graphic health warnings; thus, studies related to the impact of the warnings on quitlines, or outcomes of callers using quitlines because of their inclusion on the warnings, may be of interest to FDA.
The graphic health warnings messages are scheduled to enter the market in September 2012, however the time-frame may be delayed because of pending litigation. At this time, FDA is exploring potential avenues to support research projects that are submitted to NIH. Researchers who wish to design and submit research studies to NIH on aspects of health warning messages should bear in mind that the period of time between submission of a successful application and obtaining funding may take 9-12 months. For a list of NIH funding mechanisms including relevant submission deadlines, please see http://grants.nih.gov/grants/funding/submissionschedule.htm.
2. Research Opportunities at TRDRP: For researchers located in California, it should be noted that TRDRP has adopted new research priorities and one of them has to do with regulatory science: "Expand the scientific basis to inform the regulation of nicotine and tobacco products at the local, state and national level.” This new research priority grew directly out the passage of the FSPTCA, and the resulting oversight of tobacco products by the FDA. TRDRP's 2012 Call for Application will be out September 1st, 2011. Go to TRDRP new website for a copy of the Call, http://www.trdrp.org/. Grants will be reviewed in the Spring of 2012 and funding decisions will be made no later than June, thus allowing successful applicants to start their research projects prior to the warning labels coming out.
3. NAQC Resources to Support Research Proposal Development: NAQC has a number of useful data sets, information and staff resources to help support research proposal development, including:
- NAQC Annual Survey of Quitlines (2005-2010) – The survey includes data that describe the types of services, budgets, call volume and utilization, training and evaluation of quitlines in the U.S. and Canada. 2009 and 2010 data also include aggregated demographic and tobacco use characteristics of quitline callers. Survey instruments are available on the NAQC web site on the "Survey of Quitlines” page http://www.naquitline.org/?page=survey.
- Minimal Data Set for Evaluating Quitlines – Includes standard questions asked at intake and 7-month follow up by all quitlines in the U.S. and Canada. The intake and follow-up questions can be found on the MDS page of the NAQC website at http://www.naquitline.org/?page=technical.
- Staff Assistance – Staff is available for one-on-one discussions with researchers about research questions, background on quitlines, partnering with quitlines, and other issues.
In addition, the Centers for Disease Control and Prevention is in the process of launching the National Quitline Data Warehouse – a new source of aggregate data from all quitlines on call volume and utilization.
NAQC also invites any researcher or research team interested in learning more about the resources that NAQC can provide with respect to data sets or facilitating relationships with quitlines, to please contact us as soon as possible:
Jessie Saul, Ph.D.
Director of Research