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

Economic analysis is increasingly being integrated into Phase III clinical trials. In 1995, the Clinical Economics Research Unit of Georgetown University Medical Center implemented a survey to assess the use of pharmacoeconomic data in the clinical development process. This survey gathered information regarding the companies ' use of economic analyses in the drug approval process and the analyses commented upon by the Food and Drug Administration (FDA) in its review (17). The results from the 1995 survey found that companies reported that pharmacoeconomic data were increasingly being submitted to the FDA in product approval packages, and that the FDA increasingly commented on these data. Given the growth of interest in economic evaluation since 1995, the survey was re-implemented in 1998 to examine the current state of the art in economic evaluation. The results indicate continuing and expanding interest in submitting pharmacoeconomic data to the FDA during the drug development process and reports of recent approval of economic claims in product labeling.