Assessing the Effects of Federal Pediatric Drug Safety Policies

Authors

Avi Dor, George Washington UniversityFollow
Taylor Burke, George Washington University
Ramona Whittington, George Washington University
Taylor Clark, George Washington University
Ruth Lopert, George Washington UniversityFollow
Sara J. Rosenbaum, George Washington UniversityFollow

Document Type

Report

Publication Date

6-2007

Keywords

Pediatric Care; FDA; Childrens' Health

Abstract

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.

Comments

Funder: Elizabeth Glaser Pediatric AIDS Foundation and the American Academy of Pediatrics.

APA Citation

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.

Open Access

1