Read the full report (PDF - 348KB)

Introduction

The Food and Drug Administration Safety and Innovation Act (FDASIA), enacted in 2012, required in section 508 that the Secretary of Health and Human Services report by July 9, 2016, and every 5 years thereafter, on various activities resulting from the implementation of sections 505A and 505B of the Federal Food, Drug, and Cosmetic Act. This report, submitted in accordance with that provision, contains a brief discussion of various pediatric drug development laws, regulations, and guidances; an assessment of the pediatric programs; as well as suggestions for improving pediatric research.

The first pediatric drug development incentive legislation was enacted as part of the Food and Drug Administration Modernization Act (FDAMA) in 1997. The 2001 Status Report to Congress, as required by FDAMA, identified a number of gaps in pediatric labeling information and an inadequate focus on certain important drug categories and age groups. With the subsequent enactment of the Best Pharmaceuticals for Children Act (BPCA) in 2002, amended in 2007, and the Pediatric Research Equity Act (PREA) in 2003, amended in 2007, we have made significant progress in terms of the number, timeliness, and successful completion of studies of drugs in pediatric populations. FDASIA made BPCA and PREA permanent.