Healthy Skepticism Library item: 5100
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: Journal Article
Breslow LH.
The Best Pharmaceuticals for Children Act of 2002: the rise of the voluntary incentive structure and congressional refusal to require pediatric testing.
Harvard J Legis 2003 Win; 40:(1):133-93
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.
Keywords:
Advisory Committees
Child*
Clinical Trials/ethics
Clinical Trials/legislation & jurisprudence*
Drug Approval/legislation & jurisprudence
Drug Industry/economics
Drug Industry/legislation & jurisprudence*
Drug Labeling
Financing, Government
Government Regulation*
Humans
Legislation, Drug*
Liability, Legal
Pediatrics*
Pharmaceutical Preparations*/adverse effects
Research Support
Therapeutic Human Experimentation/ethics
Therapeutic Human Experimentation/legislation & jurisprudence*
United States
United States Dept. of Health and Human Services
United States Food and Drug Administration*
