ORIGINAL CONTRIBUTION Economic Return of Clinical Trials Performed Under the Pediatric Exclusivity Program

HISTORICALLY, ONLY 25 % OFapproved drugs marketed inthe United States have suf-ficient pediatric data to sup-port approval of product labeling by the US Food and Drug Administration (FDA) for dosing, safety, or efficacy in children.1 Inadequate dosing and safety information places children at risk for adverse events and denies them poten-tial therapeutic benefits.2,3 In 1994, the FDA encouraged spon-sors to obtain more pediatric drug data; however, new studies were not required, and the number of new studies was minimal.4 In 1997, Con-gress passed the US Food and Drug Administration Modernization Act.5 Section 505A of this act, known as th