Regulatory Priorities

Transcription

1 Lawrence Deyton, M.S.P.H., M.D. Director, Center for Tobacco Products U.S. Food and Drug Administration 9200 Corporate Boulevard Rockville, MD Dear Dr. Deyton: On behalf of our 157,000 member dentists, we would like to thank you for inviting us to participate in the June 9 stakeholder discussion to gather input from public health advocates on the regulation of tobacco products. We appreciate being one of only 30 public health organizations invited to participate and, as a follow-up, are pleased to share our perspective on several points raised during the discussion. Regulatory Priorities The ADA s top priority with respect to implementing the Family Smoking and Tobacco Control Act is to ensure policies designed to prevent tobacco use are rooted in (and guided by) sound science. Toward that end, we are eager to support your agency in developing the scientific framework for evaluating modified risk tobacco products. * As a matter of public health, we have become increasingly alarmed by industry attempts to encourage smokers to migrate from cigarettes to smoke-free tobacco products. 1,2 Such efforts are premised on the idea that some tobacco products are safer than others and that the burden of death and disease [can be decreased], without completely eliminating nicotine and tobacco use. 3 There is currently not enough evidence and certainly no scientific consensus to support claims that smokeless tobacco products are safer than combustible tobacco products and will magically reduce the number of smokers. 4,5 The vast body of credible, peer-reviewed science actually suggests that smokeless tobacco products may be a gateway drug that can lead users to a lifetime of cigarette smoking. 6,7,8,9 Among persons who had used both smokeless tobacco and cigarettes in their lifetime, almost one-third started using smokeless tobacco first. 10 Researchers have also found that adolescent boys who use smokeless tobacco products are more likely to be cigarette smokers than boys who do not use smokeless tobacco. 11,12 * Required by sec. 911 of the Federal Food, Drug, and Cosmetic Act [Pub. L ; 21 U.S.C. 387k(l)(1)], as added by sec. 101(b) of the Family Smoking and Tobacco Control Act [Pub. L ; 123 Stat. 1818].

2 Page 2 We are pleased that the Act prohibits smokeless tobacco from qualifying as a modified risk product solely because of being labeled or advertised as smokeless. 13 At the same time, a scientific standard is needed to prevent smokeless tobacco from being marketed as a modified risk product without scientific justification. Defining the Public Health Standard The Family Smoking and Tobacco Control Act requires the FDA to justify the regulation of individual tobacco products, ingredients and/or components based on an objective public health standard. Defining a standard that is appropriate for the protection of the public health will be difficult, however, because the law limits the agency s ability to apply the traditional safe and effective standard used for drugs and medical devices. Tiered classification system. We urge the FDA to consider using a tiered classification system to categorize tobacco products based on the level of control needed to assure the public s health. The FDA uses a similar model for the classification of medical devices. Optimal vs. compromised standard(s). Whenever feasible, we urge the FDA to distinguish an optimal public health standard from a compromised public health standard. In doing so, the FDA should identify the statutory restriction that prevents the agency from adopting the optimal standard(s). Developing the Science Base In April 2012, the FDA is scheduled to publish regulations and/or guidance on the scientific framework for assessing and reviewing modified risk tobacco products. In developing the scientific framework for evaluating those products, we believe much can be learned from current efforts to develop a national infrastructure for comparative effectiveness research. Comparative effectiveness research (CER) sometimes also referred to as patient-centered outcomes research (PCOR) is defined by the Institute of Medicine (IOM) as the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. 14 In theory, CER would enable health care practitioners to compare the clinical effectiveness benefits and risks of two or more treatments for patients presenting with the same health condition. Likewise, it may be possible to adapt the principles of comparative effectiveness research to develop the scientific framework for assessing and reviewing modified risk tobacco products. Comparative effectiveness model. We recommend that the CTP consider engaging the Agency for Healthcare Research and Quality (AHRQ) and the Patient- Centered Outcomes Research Institute (PCORI) to explore whether and how the Required by sec. 907(a)(3) of the Federal Food, Drug, and Cosmetic Act [Pub. L ; 21 U.S.C. 387g(a)(3)(A)], as added by sec. 101 of the Family Smoking Prevention and Tobacco Control Act [Pub. L ; 123 Stat. 1800]. Required by sec. 911 of the Federal Food, Drug, and Cosmetic Act [Pub. L ; 21 U.S.C. 387k(l)(1)], as added by sec. 101(b) of the Family Smoking and Tobacco Control Act [Pub. L ; 123 Stat. 1818].

3 Page 3 principles of comparative effectiveness research can be used to develop the scientific framework for assessing and reviewing modified risk tobacco products. Systematic reviews. We recommend establishing strict inclusion criteria for the studies evaluated in any systematic reviews to ensure that the conclusions are based on the highest level of scientific evidence. We also urge that special weight be given to studies that have been peer-reviewed and are based on the scientific method. Disease-based comparisons. We recommend that systematic reviews of potential modified risk products be limited to studying only one disease or condition per systematic review. Labeling and advertising. We recommend that any modified risk labeling or advertising be limited to only one disease or condition per statement. We also recommend that such claims specify the control product against which the modified risk product was compared. Recommendation statements. We suggest that any scientific recommendation statements about whether to permit the commercial marketing of a tobacco product as modified risk should resemble those of the U.S. Preventive Services Task Force (USPSTF). The grades might be issued along the lines of: "A" (approves), "B" (approves with modification), "C" (no recommendation for or against), "D" (recommends against), or "I" (insufficient evidence to recommend for or against). Outreach and Public Education Dentists are well positioned to help prevent the oral health effects of tobacco use. More than two-thirds of individuals and one-half of cigarette smokers in the United States visit the dentist each year. 15,16 Dentists can use those visits to counsel patients about the oral health effects of tobacco use, refer patients to tobacco quitlines and provide other science-based interventions to help curb tobacco use Online resource center. We recommend that the FDA, in cooperation with the Centers for Disease Control and Prevention, compile an online list of best practice documents highlighting prevention techniques that can be easily incorporated into dental settings. We would be happy to collaborate with you in developing such a resource. Coordination and Communication The Center for Tobacco Products (CTP) has done a commendable job of engaging the dental community while implementing the Family Smoking and Tobacco Control Act. We are grateful to you for leveraging the dental community s expertise by appointing a dentist to serve on the Tobacco Products Scientific Advisory Committee (TPSAC). We are also appreciative for the invitation to participate in the June 9, 2011, stakeholder discussion to gather input from public health advocates. The CTP has also done a tremendous job of engaging the larger public health community during implementation of the Act.

4 Page 4 Online information. The CTP has done an exemplary job of using the FDA s website to share information with the public. The site is extremely well organized and provides ready access to the latest news and events, regulatory and guidance documents, and public dockets open for comment. The content has also been relevant to our needs. The overview of the Act (and timeline for implementation) has been particularly helpful. Electronic updates. We applaud the CTP for employing sound best practices in using to communicate with stakeholders. We receive CTP s on a timely basis and the content is bulleted and summarized. Hyperlinks are also embedded for access to additional information on the FDA s website. These practices save us time and that has not always been our experience with electronic communications from other agencies. PARTNERS coalition. We recommend that the CTP maintain its well-established relationship with the Partners for Effective Tobacco Policy (PARTNERS), a public health coalition led by the Campaign for Tobacco-Free Kids (CTFK). The ADA has worked with the PARTNERS coalition for many years to ensure oral health is addressed in the regulation of tobacco products. As public health professionals, the dental community has long advocated for science-based policies to eliminate the death and disease associated with tobacco use. We thank you for leveraging the dental community s expertise by inviting us to participate in the June 9 panel. Please contact Mr. Robert J. Burns if you have any questions. Bob can be reached at or burnsr@ada.org. Sincerely, /s/ Raymond F. Gist, D.D.S. President /s/ Kathleen T. O Loughlin, D.M.D., M.P.H. Executive Director RFG:KTO:rjb

5 Page 5 References 1 Letter from Bryan Cave (U.S. Smokeless Tobacco Company) to David S. Clark (U.S. Federal Trade Commission), requesting an advisory opinion regarding the acceptability of communicating in advertising that smokeless tobacco products are considered to be a significantly reduced risk alternative as compared to cigarette smoking, February 5, Richard H. Verheij, Can Tobacco Cure Smoking? A Review of Tobacco Harm Reduction, testimony before the Subcommittee on Commerce, Trade, and Consumer Protection of the House Committee on Energy and Commerce, 108th Cong., 1st sess., June 3, Robert B. Wallace and Irene Ensminger Stecher, A Framework for Scientific Assessment and Regulation of Products for Tobacco Harm Reduction, testimony to the House Committee on Government Reform,, 108th Cong., 1st sess., June 3, Richard H. Carmona, Can Tobacco Cure Smoking? A Review of Tobacco Harm Reduction, testimony before the Subcommittee on Commerce, Trade, and Consumer Protection of the House Committee on Energy and Commerce, 108th Cong., 1st sess., June 3, The Clinical Practice Guideline Treating Tobacco Use and Dependence 2008 Update Panel, Liaisons, and Staff. A clinical practice guideline for treating tobacco use and dependence: 2008 update. A U.S. Public Health Service report. Am J Prev Med 35, no. 2 (2008): Institute for Social Research, The University of Michigan, Monitoring the Future, 7 American Academy of Pediatrics, Things You Should Know about Smokeless Tobacco, 8 CDC, Is smokeless tobacco safer than cigarettes?, SGR4Kids, 9 H.H. Severson, K.K. Forrester, and A. Biglan, Use of smokeless tobacco is a risk factor for cigarette smoking, Nicotine Tob Res Dec;9(12): Substance Abuse and Mental Health Services Administration, Office of Applied Studies. (February 19, 2009). The NSDUH Report: Smokeless Tobacco Use, Initiation, and Relationship to Cigarette Smoking: 2002 to Rockville, MD. 11 Scott L. Tomar, Is use of smokeless tobacco a risk factor for cigarette smoking? The U.S. experience, Nicotine & Tobacco Research 5(4): , August Scott L. Tomar, Hillel R Alpert, and Gregory N Connolly, Patterns of dual use of cigarettes and smokeless tobacco among US males: findings from national surveys, Tob Control 19, no. 2 (2010): Prohibited by sec. 911 of the Federal Food, Drug, and Cosmetic Act [Pub. L ; 21 U.S.C. 387k(b)(2)(c)], as added by sec. 101(b) of the Family Smoking and Tobacco Control Act [Pub. L ; 123 Stat. 1813]. 14 Institute of Medicine, Initial National Priorities for Comparative Effectiveness Research (Washington, DC: The National Academies Press, 2009), Centers for Disease Control and Prevention (CDC). Behavioral Risk Factor Surveillance System Survey Data: Visited the dentist or dental clinic within the past year for any reason. Atlanta, Georgia: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, R. Hebert, What s new in nicotine & tobacco research?, Nicotine Tob Res 2005;7(supplement 1):S1-S3. 17 Linda M. Martin, Jerry E. Bouquot, et al., Cancer prevention in the dental practice: oral cancer screening and tobacco cessation advice, J Public Health Dent 56, no. 6 (1996): Scott L. Tomar, Corinne G. Husten, and Marc W. Manley, Do dentists and physicians advise tobacco users to quit? J Am Dent Assoc 127, no. 2 (1996): Scott L. Tomar, Dentistry s role in tobacco control, J Am Dent Assoc 132, suppl. 1 (2001): 30S-35S.

6 Page 6 20 Shaohua Hu, Unto Pallonen, et al., Knowing how to help tobacco users: Dentists familiarity and compliance with the clinical practice guideline, J Am Dent Assoc 137, no. 2 (2006): Karen M. Crews, Christine E. Sheffer, et al., A survey of oral and maxillofacial surgeons tobaccouse related knowledge, attitudes and intervention behaviors, J Am Dent Assoc 139, no. 12 (2008): Judith S. Gordon, Judy A. Andrews, et al., The impact of a brief tobacco-use cessation intervention in public health dental clinics, J Am Dent Assoc 136, no. 2 (2005):