Is pediatric exclusivity working?. Issue 1 (October 2007)

• Record Type: Journal Article
• Authors: Li, Jennifer S; Smith, P Brian; Califf, Robert M; Benjamin, Daniel K
• Is Part Of: Pediatric health. Volume 1:Issue 1(2007)
• Page Start: 43
• Page End: 49
• Publication Date: 2007-10
• Subjects: children -- clinical trials -- dosing -- drugs -- efficacy -- pediatric exclusivity -- safety; Pediatrics -- Periodicals; 618.920005
• DOI: 10.2217/17455111.1.1.43
• Languages: English
• ISSNs: 1745-5111

Abstract

Most drugs prescribed for children have not undergone pediatric testing; therefore, the data on dosing, efficacy and safety that are available for adults are not usually available for children. In 1997, Congress authorized the US FDA to grant extensions of marketing rights known as ''pediatric exclusivity'' if FDA-requested pediatric trials are conducted. Although the program has been praised for stimulating an unprecedented number of drug studies in children, it has been criticized as an economic ''windfall'' to prescription-drug manufacturers. The benefits of pediatric exclusivity are immeasurable towards improving child health, yet there exist many opportunities to improve the pediatric exclusivity program.