title: The Best Pharmaceuticals for Children Act of 2002: the rise of the voluntary incentive structure and congressional refusal to require pediatric testing.
abstract: On January 4, 2002, President Bush signed into law the Best Pharmaceuticals for Children Act, which is the government's most comprehensive legislation regarding pediatric research to date. The Act offers pharmaceutical companies a six-month exclusivity term in return for their agreement to conduct pediatric tests on drugs. It also provides public funding and organizes private funding to help conduct pediatric research on those drugs that pharmaceutical companies opt not to test in children. This Note reviews the history of pediatric research and traces the development of the Best Pharmaceuticals for Children Act's unique incentive and public funding structure. The Note contends that, while the Act is comprehensive and promotes important pediatric studies, its incentive structure forces consumers and taxpayers to bear the costs of testing pharmaceuticals in children instead of the manufacturers who research, develop, and market those drugs. Congress should consider mandating pediatric studies in any future enactment of the legislation.
authors.affiliation: Honorable Barbara S. Jones, United States District Judge for the Southern District of New York, USA.
authors.forename: Lauren Hammer
authors.initials: LH
authors.lastname: Breslow
mesh_terms: D026683:Advisory Committees; D002648:Child; D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence; D004345:Drug Industry / Q000191:economics / Q000331:legislation & jurisprudence*; D004348:Drug Labeling; D064420:Drug-Related Side Effects and Adverse Reactions; D005380:Financing, Government; D033161:Government Regulation; D006801:Humans; D007880:Legislation, Drug; D016365:Liability, Legal; D010372:Pediatrics; D004364:Pharmaceutical Preparations; D012109:Research Support as Topic; D036302:Therapeutic Human Experimentation / Q000941:ethics / Q000331:legislation & jurisprudence*; D014481:United States; D014483:United States Dept. of Health and Human Services; D014486:United States Food and Drug Administration
chemical_list: D004364:Pharmaceutical Preparations