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Clark Nardinelli, Director
We do all of the economic analysis for the Office of the Commissioner and for most of the rest of the FDA. We ensure that cost-benefit and cost-effectiveness analyses of FDA regulations fulfill all economic requirements, as well as provide the best possible economic information to the FDA management and staff responsible for regulatory decisions. We collect, maintain, and analyze data on FDA-regulated products and carry out special research projects on significant topics affecting the agency or its responsibilities. In all of these activities, we serve as objective, unbiased economic analysts who let management and staffs know the economic implications of actions and events. In this role, we advise and assist the Commissioner and other key officials on a day-to-day basis on the economic implications of current and proposed agency activities.
We see that economic data used by the agency are of the highest quality and that the methods used to analyze them are appropriate. We also present the economics of FDA activities outside the agency. We supply FDA representation on economic matters to the Department of Health and Human Services, the Office of Management and Budget, Congress, and other outside organizations and groups. We supply economic research material for use by agency officials in preparing testimony before congressional committees and in developing replies to inquiries directed to the agency. As a behavioral science, applied economics is particularly relevant to policies likely to influence the behavior of patients, industry, or healthcare professionals. We therefore carry out background research on many of the most pressing healthcare problems facing the agency.
Topics we have recently studied as part of special research projects include:
- the returns of market exclusivity granted to drug sponsors who conduct pediatric trials;
- the market size for follow-on protein-based drug products;
- the agency’s workload associated with increasing review activities under the Prescription Drug User Fee Act;
- potential economic gains associated with genetically-engineered animals;
- trends in drug approvals;
- measures of drug safety; and
- effects of potential financial conflicts-of-interest on FDA advisory committees.