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.
Financial & competing interests disclosure
Supported by grant 1UL 1RR024128–01 from the National Center for Research Resources and NIH. DK Benjamin received support from K23 HD044799–02 and 5U10 HD045962–04.
JS Li has received research support from Bristol-Myers Squibb, Sanofi-Aventis, Pfizer, The National Institute of Child Health and Human Development (NICHD), the National Hearth, Lung and Blood Institute (NHLBI), First Horizon, Medlmmune and ID Biomed; and salary support from the National Institutes of Health (NIH). JS Li does not own any stock or hold financial interest in any of the listed companies. PB Smith has received research support from Astellas Pharma US, Inc. RM Califf reported research and salary support from Guilford Pharmaceuticals, Millennium Pharmaceuticals, the NIH, Novartis, and Schering Plough and has personally received funding support from Conceptis and has equity in NITROX LLC. Educational activities or lectures provided by RM Califf generate revenue for Duke University from the following companies: Aventis, Bristol-Myers Squibb, Conceptis, Guilford Pharmaceuticals, Merck, Novartis, Pfizer, Sanofi-Aventis, Schering Plough and the Medicines Company. Dr Benjamin has received research support form Cape Cod Associates, Astellas, MedImmune, NABI Biopharmaceutical, the National Institutes of Allergy and Infectious Diseases (NIAID), NICHD, Pedatrix, Pfizer, Rockeby, Thrasher Research and Vicuron; fellowship funding from AstraZeneca and Johnson & Johnson; speaking and consulting honoraria from Enzon, Ligocyte, Ross and Vicuron. DK Benjamin does not own any stock or hold financial interest in any of the listed companies.
The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of this manuscript.