Analysis of the Pediatric Age Groups Studied in Novel Drug Approvals

Background and Objectives: According to the Food and Drug Administration (FDA), prior to 2007 more than 80% of drugs approved in adults were being used off-label in pediatrics. In order to improve data on the use of drugs in children, Congress authorized two acts, the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA). The impact of these acts on the age groups for which new drugs are approved has not been evaluated. The objective of this study was to evaluate the …