The Emerging Role of the Food and Drug Administration in Pharmacoeconomic Evaluation during the Drug Development Process

Abstract

Economic analysis is increasingly being integrated into Phase III clinical trials. A survey was developed to assess the use of pharmacoeconomic data in the clinical development process. To date, the extent and scope of these activities in drug development is relatively unknown. This survey gathered information regarding the companies' use of economic analyses, the data submitted to the Food and Drug Administration (FDA) in the drug approval process, and the analyses commented upon by the FDA in its review. The survey was sent to the senior person responsible for pharmacoeconomics at 22 major American pharmaceutical companies. It was found that companies report that pharmacoeconomic data are increasingly being submitted to the Food and Drug Administration in product approval packages, and that the FDA increasingly comments on these materials. It is believed that these data elements will play an increasingly important role in the clinical development process in the future.