What About the Children? - FDA's Response to Pediatric Drug Testing

Abstract

The Federal Food and Drug Administration (FDA) has played a critical role in the protection of human subjects in research. Most recently, FDA enacted an interim final rule regarding protection of children in clinical investigations. FDA’s interim rule represents its most current policy on human subject protection. Current events illuminate FDA’s policies and how FDA has chosen to respond to debates over pediatric drug testing. This paper will provide a brief history of FDA’s participation in human subject protection. This paper will then focus on FDA’s policies for pediatric research, its interim rule, and how the interim rule relates to current events. Finally, this paper will make a comment about how FDA balances its competing duties of protecting the public but also of promoting research.