First Annual Invited Speaker Series Presents: Mark Clanton, MD, MPH The Role of Regulatory Sciences The Role of Regulatory Sciences in the Advancement of T in the Advancement of Tobacco obacco Contr Control Policy ol Policy Thursday April 10, 2014 10:30 AM Austin 6.362 Houston W-304 via ITV Reception to Follow Available vailable via ITV to Regional Campuses. Please Contact the ITV tech at your local campus. via ITV to Regional Campuses. Please Contact the ITV tech at your local campus.
Mark ¡S. ¡Clanton, ¡MD, ¡MPH ¡ • Former Chief Medical Officer and VP of Pharmacy Programs of Blue Cross Blue Shield of Texas. Undergraduate degree from Howard University in Washington, D.C. • Medical degree from Tulane University Medical School in New Orleans, LA • Pediatric training at Baylor Pediatric Residency Program in Houston, TX • MPH with a concentration in Health Policy and Management from the Harvard University School of Public Health. ¡ • Independent health care consultant for National Cancer Institute designated Cancer Centers • Inaugural voting member of the Food and Drug Administration's Tobacco Products Scientific Advisory Committee • Deputy director of National Cancer Institute-2004 to 2006 Recipient of two Secretary of Health and Human Service Distinguished Service Awards during his NCI tenure.
THE ROLE OF REGULATORY SCIENCES IN THE ADVANCEMENT OF TOBACCO CONTROL POLICY The Tobacco Center of Regulatory Science on Youth and Young Adults 1 st Annual Invited Speaker Series April 10 University of Texas School of Public Health Dr. Mark Clanton, M.D., M.P.H
DISCLOSURE Former Inaugural Tobacco Products Scientific Advisory Committee voting member • • Current Special Government employee of the U.S. Food and Drug Administration • Views represented in this presentation are the speakers alone and do not represent any official position or policy of the Food and Drug Administration or the Tobacco Product Scientific Advisory Committee. • No financial conflicts to disclose
KEY CONCEPTS A word about knowledge creation and translation and Tobacco Centers for Regulatory • Science Family Tobacco Prevention Act Authorization of the FDA to regulated Tobacco Products • U.S. Food and Drug Administrations Tobacco Regulatory role • FDA Center for Tobacco Products Tobacco Products Scientific Advisory Committee •
KEY CONCEPTS • Tobacco Centers for Regulatory of Regulatory Science (TCORS) • Translational Engines supporting regulatory science for tobacco policy • Translational Science (Regulatory Science)
KEY CONCEPTS • Unregulated tobacco products and research into taste perception, tobacco initiation, use and mixed use • Concepts important to the performance of the TCORs • The importance of Translational and Regulatory Science as applied to or expressed through the TCORs
EPISTEMOLOGY AND HUMAN HEALTH RESEARCH • Epistemology is a branch of philosophy concerned with the nature, scope and acquisition of knowledge • Practical aspects of the field: • The field also focuses on how knowledge relates to the connected notions of truth, belief and justification • This field provides the philosophical underpinnings of Basic Scientific Inquiry (pure science) 1. Encyclopedia of Philosophy, Vol. 3, 1969. 2. http://en.wikipedia.org/wiki/Epistemology
THE YIN AND YANG OF BASIC VS. TRANSLATIONAL SCIENCE Hence, we do not view basic and translational science as one being more • important than the other but rather as complementary areas of human endeavor, with the important distinction that basic science findings often precede advances in translational science. • We also note that observations in translational or applied science can generate new questions for fundamental research, as illustrated from the fact that vaccination preceded the field of immunology. • Hence, the epistemological flow is bidirectional, and investments in both types of science are needed. Lost in Translation-Basic Science in the Era of Translational Research, Fang, Casadevall Infect Immun. Feb 2010; 78(2); 563-566
EPISTEMOLOGY AND HUMAN HEALTH • The study of knowledge and knowing speaks directly to the belief that scientific inquiry for its own sake is sufficient. • However the epistemological notions of truth (evidence) and belief (behavior) are also central to understanding human health. • Biomedical and public health research will always target the ultimate goal of use (translation) of basic research knowledge for the purpose of preventing premature death and the elimination of suffer from disease
TCOR TEAMS • TCOR investigators and teams while attempting to understand the answers to specific research questions(knowledge), must vigilantly keep a eye toward translation. • The findings will be used both to inform the field and specifically used to shape • Tobacco Regulatory Science • Tobacco Regulator Policy • Tobacco Legislation • High Utility to Tobacco control interventions
JOHANN WOLFGANG GOETHE Knowing is not enough, we must apply Willing is not enough; we must do
FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT
FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT � The legislation was sponsored by U.S. Reps. Henry Waxman (D-CA) and Todd Platts (R-PA) and the late U.S. Senator Edward Kennedy (D- MA). � June 22, 2009, President Obama signed into law the Family Smoking Prevention and Tobacco Control Act, which gives the U.S. Food and Drug Administration the authority to regulate tobacco. Pub. L. 111-31
FSPTCA AND THE FDA Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to provide for the regulation of tobacco products by the Secretary of Health and Human Services through the Food and Drug Administration (FDA) Defines a tobacco product as any product made or derived from tobacco that is intended for human consumption.
DIRECTS THE SECRETARY TO ESTABLISH THE CTP WITHIN THE FDA (1) the Center for Tobacco Products to implement this Act; (2) an identifiable office to provide technical and other nonfinancial assistance to assist small tobacco product manufacturers in complying with this Act.
ALLOWS THE SECRETARY TO REQUEST ADDITIONAL INFORMATION FROM A TOBACCO PRODUCT MANUFACTURER OR IMPORTER (1) research activities or findings on the effects of tobacco products and their constituents and on whether the health risk can be reduced if the manufacturer employs known or available technology; (2) marketing research or practices used by manufacturers or distributors. (3) Sets forth notifications that manufacturers must make to the Secretary regarding any change in a tobacco product. Requires the Secretary to publicly display and annually publish a list (that is understandable and not misleading to a lay person) of harmful or potentially harmful constituents in each tobacco product by brand and quantity.
REQUIRES TOBACCO MANUFACTURERS OR IMPORTERS TO SUBMIT TO THE SECRETARY (1) a listing of all ingredients, including ingredients added by the manufacturer to the tobacco, paper, or filter, by brand and quantity; (2) a description of the content, delivery, and form of nicotine in each tobacco product; (3) a listing of all constituents, including smoke constituents, identified by the Secretary as harmful or potentially harmful to health in each tobacco product; (4) all documents developed that relate to the health, toxicological, behavioral, or physiologic effects of tobacco products and their constituents, ingredients, components, and additives.
ALLOWS THE SECRETARY TO REQUIRE PRIOR APPROVAL OF ALL LABEL STATEMENTS ON TOBACCO PRODUCTS TO ENSURE THAT SUCH STATEMENTS (1) do not violate misbranding provisions; � (2) comply with other provisions of this Act.
THE FSPTA ACT PROVIDES FOR AN FDA SCIENTIFIC ADVISORY COMMITTEE • The ACT creates, along with the Center for Tobacco Products, the Tobacco Products Scientific Advisory Committee • TPSAC review and advisory responsibilities and authority • TPSAS Congressionally mandated reports
TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE � The Committee may review new tobacco products or petitions for exemptions under Section 906(e) � The Committee may provide recommendations to the Secretary regarding any regulations to be promulgated under the act
TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE � TPSAC reviews and evaluates safety, dependence, and health issues relating to tobacco products and provides appropriate advice, information and recommendations to the Commissioner of Food and Drugs.
TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE � The TPSAC advises the commissioner in discharging responsibilities as they relate to the regulation of tobacco products
TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE � Effects of the alteration of nicotine yields from tobacco products � Level where nicotine yields do not produce dependence
TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE � Any application submitted by a manufacturer for a modified risk tobacco product
CONGRESSIONALLY MANDATED REPORTS
TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE The Committee will submit reports or � recommendations on tobacco related topics including: Impact of the use of menthol in � cigarettes on the public health - Children - African Americans - Hispanics - Other racial and ethnic minorities
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