Dissertation Research: Decisions at Scientific Agencies: How Do the NIH and the FDA Balance Expert Opinions, Changing Agendas, and Political Pressure?

Yale University, New Haven CT

Investigators

Abstract

How do scientific agencies fulfill their science mandates in a democracy that asks them to consider non-scientific factors? Why might the NIH and the FDA, both scientific agencies that address medical policy, have different reactions to similar pressure? This Research on Science and Technology Dissertation Improvement Grant will examine how these two agencies balance the conflicting tensions associated with the need to rely on scientific experts, mandates to improve health, and their responses to competing pressures from Congress and interest groups. The analysis will focus on the period 1970-2003 and will examine the impacts of the women's and minority health social movements, Congressional oversight, and agency decision-making processes on NIH grant awards and FDA drug approval decisions. The agencies are hypothesized to respond differently to pressure because of important internal differences in their decision-making processes, such as how they use expert panels, as well as external differences in their interest group environments. The research will employ both qualitative and quantitative methods, including interviews with agency, Congressional, and interest group leaders and staff, review of archival materials, and multivariate analysis of agency decisions such as the speed of new drug review and research grant funding. Throughout the analysis, the comparisons between these two scientific agencies will highlight their potentially similar and differential responses to their political environments. The contribution of this dissertation will be in several areas. First, the conceptual analysis will analyze the characteristics of scientific agencies, a class of agencies that have not been adequately examined, and propose testable hypotheses about their behavior. Second, this study will be the first to examine the impacts of the women's and minority health movements on scientific agencies and will be the first to explore the expanded role of women, minorities, and patients in scientific agencies. Understanding how these agencies responded to these changes will help policymakers broaden the participation of underrepresented groups. Third, this study will compare priority setting at two federal agencies responsible for producing and utilizing scientific knowledge. The study will be the first comprehensive analysis of how politics affect the research process at the NIH and will contribute to the growing literature on the politics of FDA regulation. Fourth, this dissertation will show how scientific agencies combine technical expertise with responsiveness to the public and the health needs of the population. The study will explain how these agencies have resolved this issue over the last 33 years, which has important implications for understanding science policies and the processes that generate science policies.