Pediatric Care; FDA; Childrens' Health
This policy analysis examines the effectiveness of pediatric exclusivity, one of the policy approaches the federal government uses to promote drug safety for children. Federal policy in this area is highly complex, and provisions related to pediatric drug safety, including pediatric exclusivity, are set to expire in 2007. Following a policy overview, this analysis summarizes the impact of pediatric exclusivity and reports on the results of our effort to shed light on the economic value of pediatric exclusivity. The analysis concludes with a discussion of options for further promoting a safe environment for drug use in children.
Dor, A., Burke, T., Whittington, R., Clark, T., Lopert, R., & Rosenbaum, S. (2007). Assessing the effects of federal pediatric drug safety policies. Washington, DC: George Washington University, School of Public Health and Health Services.