Give them what they want? The permissibility of pediatric placebo-controlled trials under the best pharmaceuticals for children act.
This article discusses the Best Pharmaceuticals for Children Act and the FDA's request for placebo-controlled studies of drugs to treat OCD and depression in children. First, the article explains the need to test drugs in children and examines the reasons this testing has not occurred. Next, the article describes the legislative and administrative responses to remedy this lack of research and assesses the ethics and legality of their implementation. The article concludes that these initiatives are legally and ethically acceptable until a safe and effective treatment is determined--at which point the use of placebos in pediatric testing must be replaced with active controls.
Lynch
Holly Fernandez
HF
Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School, USA.
D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence*; D033161:Government Regulation; D006801:Humans; D010372:Pediatrics; D010919:Placebos; D014481:United States
D010919:Placebos