title: Review of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act: What can the obstetric community learn from the pediatric experience?
abstract: Children have been called therapeutic orphans as they have been excluded from drug research and new drug development resulting in the lack of proper labels for majority of the drugs for pediatric use. The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) are two legislative mandates to improve pediatric drug labeling. The BPCA legislation authorizes the National Institutes of Health (NIH) to implement research programs through funding clinical trials to study off-patent drugs in pediatric population. Obstetric pharmacology research gaps are in many ways similar to those in pediatrics, including off-label use of common medications, and lack of knowledge of appropriate dosing, safety, and efficacy of drugs. Much research is needed to define mechanisms of disease and drug actions in pregnant women to fill the knowledge gaps.
authors.affiliation: Obstetric and Pediatric Pharmacology and Therapeutics Branch, The Eunice Kennedy Shriver, National Instititute of Child Health and Human Development, National Institutes of Health, 6100 Executive Boulevard, Suite 4A01, MSC 7510, Besthesda, MD 20892-7510.
authors.forename: Zhaoxia
authors.initials: Z
authors.lastname: Ren
authors.affiliation: Obstetric and Pediatric Pharmacology and Therapeutics Branch, The Eunice Kennedy Shriver, National Instititute of Child Health and Human Development, National Institutes of Health, 6100 Executive Boulevard, Suite 4A01, MSC 7510, Besthesda, MD 20892-7510. Electronic address: zajiceka@mail.nih.gov.
authors.forename: Anne
authors.initials: A
authors.lastname: Zajicek
mesh_terms: D000367:Age Factors; D035843:Biomedical Research; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D004348:Drug Labeling / Q000331:legislation & jurisprudence; D064420:Drug-Related Side Effects and Adverse Reactions; D033161:Government Regulation; D006801:Humans; D056687:Off-Label Use / Q000331:legislation & jurisprudence; D010372:Pediatrics; D055553:Prescription Drugs / Q000493:pharmacokinetics*; D011358:Product Surveillance, Postmarketing; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence
chemical_list: D055553:Prescription Drugs