Impact of pediatric exclusivity on drug labeling and demonstrations of efficacy

• Published in: Pediatrics (Evanston) Vol. 134; no. 2; p. e512
• Main Authors: Wharton, Gerold T, Murphy, M Dianne, Avant, Debbie, Goldsmith, John V, Chai, Grace, Rodriguez, William J, Eisenstein, Eric L
• Format: Journal Article
• Language: English
• Published: United States 01.08.2014
• Subjects: Clinical Trials as Topic; Drug Approval; Drug Industry - economics; Drug Labeling; Drug Therapy; Humans; Marketing; Patient Selection; Research Subjects; Treatment Outcome; United States; United States Food and Drug Administration; United States; gastrointestinal; FDA; blockbuster drug; negative studies; drug safety; pediatric exclusivity; clinical trials; labeling changes; cancer/oncology; drug sales; efficacy; moiety

Besides vaccines and otitis media medicines, most products prescribed for children have not been studied in the pediatric population. To remedy this, Congress enacted legislation in 1997, known as pediatric exclusivity (PE), which provides 6 months of additional market protection to drug sponsors in...