Abstract IA13: Connecting science to law: Understanding the policymaking process

Abstract

Abstract Tobacco use remains the leading cause of preventable death in the U.S., killing 480,000 Americans a year. To address the death and disease caused by tobacco use, Congress enacted the Family Smoking Prevention and Tobacco Control Act (FSPTCA) in 2009, granting the U.S. Food and Drug Administration (FDA) broad authority to regulate the manufacture, marketing, and sale of tobacco products. In order to help build the science base for tobacco regulation, the FDA has invested heavily in “tobacco regulatory science.” In partnership with the National Institutes of Health (NIH), it is investing $273 million over five years in the Tobacco Centers of Regulatory Science (TCORS) initiative. The TCORS program funds 14 centers at academic institutions (including Ohio State) that conduct research relevant to the FDA's regulation of tobacco. This initiative is a unique partnership between a regulatory agency and researchers, developed with the explicit expectation that the research will directly inform the FDA's regulatory actions. To conduct research that will assist the FDA in fulfilling its regulatory mission, researchers must venture outside of their comfort zone and consider the relevant legal and policy environment. More specifically, scientists engaged in tobacco regulatory science must consider at least four different questions: (1) what FDA regulatory action(s) might my research inform?; (2) what types of evidence would the FDA need to consider in order to take such actions?; and (3) if such a regulation were reviewed in court, what questions would the courts ask about the available evidence? Failure to consider these questions may lead to research that, while scientifically valid, does not advance the FDA's ability to fulfill its regulatory mission. Thus, in order for the TCORS program to succeed, there must be a productive and ongoing dialogue between scientists and attorneys familiar with the regulatory landscape. This presentation will discuss the need for better coordination between scientists and attorneys, particularly in the context of tobacco regulatory research. It will also discuss how law acts as a social determinant of health that has a significant impact (both positive and negative) on health disparities. Citation Format: Micah L. Berman. Connecting science to law: Understanding the policymaking process. [abstract]. In: Proceedings of the Seventh AACR Conference on The Science of Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; Nov 9-12, 2014; San Antonio, TX. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2015;24(10 Suppl):Abstract nr IA13.