NIDA/FDA Collaborations

Transcription

1 NIDA/FDA Collaborations Wilson M. Compton, M.D., M.P.E. Director, Division of Epidemiology, Services and Prevention Research National Institute on Drug Abuse National Institutes of Health

2 Tobacco use is the leading preventable cause of disease and death in the U.S. 8.6 million smokers have at least one serious illness due to smoking Approximately 443,000 U.S. deaths each year from cigarette use and second hand smoke More deaths than caused by HIV, illegal drug use, alcohol use, motor vehicle injuries, suicides, and murders combined

3 Adult per capita cigarette consumption, the United States, Warner K E, Mendez D Nicotine Tob Res 2010;12:

4 MTF Lifetime Cigarette Use among Students, by Grade th Grade 10th Grade 12th Grade Denotes significant difference between 2010 and SOURCE: University of Michigan, 2011 Monitoring the Future Study

5 MTF Past Month Cigarette Use, Marijuana Use, among Students, by Grade Marijuana-8th Marijuana-10th Marijuana-12th Cigarettes-8th Cigarettes-10th Cigarettes-12th Denotes significant difference between 2010 and SOURCE: University of Michigan, 2011 Monitoring the Future Study

6 NSDUH - Past Month Tobacco Use, Persons Aged 12 or Older: Tobacco Products Cigarettes Cigars Smokeless Tobacco Pipe Tobacco + Difference between this estimate and the 2010 estimate is statistically significant at the.05 level.

7 Family Smoking Prevention and Tobacco Control Act (FSPTCA) FSPTCA gave the Food and Drug Administration (FDA) the authority to regulate tobacco-product advertising, labeling, marketing, constituents, ingredients and additives. These regulatory changes are expected to influence tobacco-product risk perceptions, exposures, and use patterns in the short term, and to reduce tobacco-related morbidity and mortality in the long term. Enacted June 22, 2009

8 The Tobacco Control Act Authorizes the FDA to: Require disclosure of tobacco product ingredients Regulate modified risk tobacco products Create standards for tobacco products Restrict tobacco sales, distribution, and marketing Require stronger health warnings on packaging and advertisements Conduct research to support tobacco product regulation

9 Tobacco Control Act - Limitations FDA does not have the authority to: Set nicotine levels to zero Ban any class of tobacco products Require prescriptions for tobacco products Set price of tobacco products Regulate medications/products marketed to treat tobacco dependence Regulate clean indoor air policies Regulate tobacco growing

10 FDA Tobacco Control Goals 1. Prevent youth tobacco use 2. Help those who use tobacco to quit 3. Promote public understanding of contents and consequences of use of tobacco products 4. Develop science base and continue meaningful product regulation to reduce the toll of tobaccorelated disease, disability, and death

11 Key FDA Tobacco Control Accomplishments to Date Examples of Specific Actions: 1. Banned flavored cigarettes 2. Required industry registration and submission of ingredients 3. Restricted access and marketing of cigarettes and smokeless tobacco products to youth 4. Prohibited misleading marketing terms ( Light, Low, and Mild ) for tobacco products 5. Required warning labels for smokeless tobacco products 6. Requiring graphic cigarette health warnings on cigarette packages and advertisements

12 Key FDA Tobacco Control Accomplishments to Date Started the Center for Tobacco Products (CTP), under the leadership of Lawrence R. Deyton, M.D., M.P.H., Director FDA-CTP Budget is $477 million in FY2012 and increases to $712 million per year for FY2019 and beyond Engaged in the development of a robust research program under the leadership of David Ashley, Ph.D., Director FDA-CTP Office of Science

13 How will FDA accomplish its extensive research goals? Collaborations are key. Especially with NIH NIH-FDA Tobacco Regulatory Science Workgroup

14 NIH-FDA Tobacco Regulatory Science Workgroup: Co-chairs: Lawrence (Bopper) Deyton and Tom Insel IC Representatives OD FIC NCI NEI NHGRI NHLBI NIAAA NICHD NIDA Robert Kaplan, Patty Mabry Xingzhu Liu Robert Croyle, Michele Bloch, Ami Bahde, Stacey Vandor Natalie Kurinij Colleen McBride William Riley Joanne Fertig, Ralph Hingson Caroline Signore Wilson Compton, Kay Wanke, Susan Weiss

15 NIH-FDA Tobacco Regulatory Science Workgroup: Co-chairs: Lawrence (Bopper) Deyton and Tom Insel IC NIDCD NIDCR NIEHS NIGMS NIMH NINDS NINR NLM Representatives Carter VanWaes Dave Clark Aubrey Miller Stephen Marcus Amy Goldstein, Denise Juliano-Bult Randall Stewart Linda Weglicki Pertti Hakkinen

16 NIH-FDA Tobacco Regulatory Science Workgroup Accomplishments Supported Studies Population Assessment of Tobacco and Health (PATH) Study (Total $117.4 M for base plus option years) Evaluating New Nicotine Standards for Cigarettes P50 Center PIs E. Donny & D. Hatsukami ($2.5 M in FY2011) In Process Funding Opportunities for FY2012 NIH Competitive Revision Applications for Research Relevant to the FSPTCA (R01s and U01s, $20M) Administrative Supplements to NIH-funded Program Projects/Center Grants: Research Relevant to the FSPTCA ($40M)

17 NIH-FDA Tobacco Regulatory Science Workgroup Accomplishments Future Funding Opportunities Consideration of Funding of NIH grants relevant to FSPTCA Other specific announcements in progress, such as Centers of Excellence for Research Relevant to the FSPTCA (P50) (NOT-DA ) Estimated FOA Publication: Spring 2012 Estimated Application Due Date: Fall 2012 Estimated Award Date: July 2013

18 Population Assessment of Tobacco and Health (PATH) Study

19 HAVE Model Host Tobacco User Vector Tobacco Industry Agent Tobacco Biomarkers Environment Familial, Social, Cultural, Workplace, Political, Economic, Historical, Media, Health Care System, etc.

20 Population Assessment of Tobacco and Health (PATH) Study National, longitudinal cohort study of 44,000+ users of tobacco products and those at risk for tobacco use ages 12 and older in the U.S. Conducted through NIDA via a contract to Westat. Funded by the Center for Tobacco Products, FDA. Results from this study will inform the impact of FDA regulatory authority over tobacco products, and help to inform future activities.

21 Specific Aims Identify trends in tobacco use, including new products; Monitor change in risk perceptions and other attitudes such as social acceptability and individual preferences; Characterize uptake/initiation, quitting, and relapse patterns; Collect biomarkers of tobacco use and disease processes (via urine, buccal, and whole-blood samples); Compare intermediate endpoints and ultimately, shortand long-term incident health outcomes and causespecific mortality among users of different products; Assess critical subgroups.

22 Sample (as currently planned) Nationally representative sample, followed yearly Ages 18+: About 38,000 (~26,000 current tobacco users; ~12,000 former/never users) Ages 12-17: About 7,000 (~1,300 current tobacco users; ~ 5,700 former & never users) Critical subgroups Young adults, (~8,500) Menthol smokers (~7,600) Dual users of cigarettes/smokeless tobacco (~700) Daily smokers (~20,800) Recent quitters (~1,100) Users of new and/or modified risk tobacco products Racial/ethnic minority groups

23 Domains (as currently planned) Outcomes Tobacco Product Use including Dual Use, Switching, New Products Tobacco Use Behaviors including Initiation, Cessation/Quitting, Relapse Health Outcomes Mediators/Moderators Demographics Knowledge, Attitudes, Beliefs, and Risk Perceptions Tobacco Addiction Peer, Environmental, Contextual influences Mental Health/Substance Abuse Co-morbidities

24 Study Timeline OMB Approval Contract Award OMB Pilot Study Submission Wave 1 Wave 2 Wave 3 Wave Deliverables * & Data Files *Deliverables include: Analytic Data File, Detailed Tables, Codebooks, and Other Reports

25 P50 Center: Evaluating New Nicotine Standards for Cigarettes (E. Donny, D. Hatsukami)

26 Product Regulation How to address through product regulation? Restrict or prohibit substances or formulations that facilitate initiation Restrict or prohibit substances that cause addictiveness Restrict or prohibit substances that are harmful Means attractiveness addictiveness toxicity Progression Initiation Established user Health problems 26 Source: Dorothy Hatsukami

27 Establishing a Nicotine Threshold for Addiction Proposal: A gradual reduction of nicotine content of cigarettes over years. Benowitz NL, Henningfield JE. Establishing a nicotine threshold for addiction. The implications for tobacco regulation. (1994). N Engl J Med, 331(2),

28 Cigarettes per Day Hatsukami et al., Addiction, December 2010

29 Projects Assessment of Very Low Nicotine Content Cigarettes Gradual vs. Immediate Reduction in Nicotine Content Very Low Nicotine Content Cigarettes in Smokers with Schizophrenia Other Constituents and Nicotine Self-administration

30 Summary of NIDA Involvement in NIH/FDA Tobacco Control Collaborations PATH Study Team NIDA: Wilson Compton, Kevin Conway, Elizabeth Lambert, Kay Wanke, Kathy Etz, Joni Rutter, Nahla Hilmi, Genevieve Vullo NIH-FDA Tobacco Regulatory Science Workgroup NIDA: Wilson Compton, Kay Wanke, & Susan Weiss HHS Tobacco Control Leadership Group Chair: Howard Koh, M.D., Assistant Secretary for Health NIDA: Wilson Compton, Kay Wanke

31 Next Steps FY 2012 Funding Opportunities - NIH Competitive Revision Applications - Administrative Supplements to Program Projects/Centers - Funding of NIH grants relevant to FSPTCA FY 2013 Plans - P50 Centers for Research Relevant to the FSPTCA - Others possible Additional Concepts - Projects Linked to PATH Study - Other NIH Efforts

32 The Vision for NIDA/FDA Collaboration Support science to gather data that will monitor, inform, support, and enhance tobacco control efforts.