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Abstract
Two-thirds of pediatric drugs currently prescribed have not been studied and labeled for pediatric use. The pediatric exclusivity provision established by the Food and Drug Administration (FDA) under Food and Drug Administration Modernization Act of 1997 (FDAMA) granted drug manufacturers six months of patent extension for conducting pediatric studies. This study seeks to identify by surveys and interviews of key stakeholders if the pediatric exclusivity provision has improved the safety and effectiveness of pediatric drugs vis-a-vis their improved labeling, dosing, and formulation information. In general, the pediatric exclusivity provision has been successful in stimulating pediatric studies by improving the labeling, dosing, and formulation of pediatric drugs. Respondents reported inadequate pediatric doses as the main problem and expensive pediatric trials as the main challenges in pediatric drug development. Well-designed pediatric studies conducted by highly trained investigators with active collaboration by parents are the key factors determining the success of studies for pediatric exclusivity.