Research Report: IOM – Safe and Effective Medicines for Children: Pediatric Studies Conducted Under BPCA and PREA
Released: February 29, 2012
Board on Health Sciences Policy, Board on Children, Youth, and Families

Until 1997, most drugs used to treat children were tested for safety and effectiveness only in adults. It was then that Congress and the FDA created policies – including what are now the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) – to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as to assess the incentives for pediatric studies of biologics – drugs derived from human or animal sources, or microorganisms – and the extent to which biologics have been studied in children.

The IOM committee concludes that policies included in BPCA and PREA have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation’s children.

http://www.iom.edu/Reports/2012/Safe-and-Effective-Medicines-for-Children.aspx