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Just a Spoonful of Sugar: Drug Safety for Pediatric Populations

Journal of Law Medicine and Ethics, Vol. 37, p. 280, 2009

Posted: 12 Jan 2012  

Barbara A. Noah

Western New England University School of Law

Date Written: January 1, 2009

Abstract

Children deserve optimal medical care. Although prescription drugs play a prominent and essential role in pediatric health care delivery, health care providers often must make prescribing decisions for their young patients based on imperfect or absent safety and efficacy data for pediatric populations. The safe and effective use of prescription drugs in children depends on a thorough understanding of the physiologic differences between children and adults. Currently, only one-third of drugs prescribed to children have been studied for safety and efficacy in pediatric populations. Until relatively recently, the Food and Drug Administration (FDA) made surprisingly little effort to improve the quality or quantity of clinical research data for this patient group. Recent agency efforts to encourage pediatric drug research have generated mixed results and created unintended consequences. The development, prescribing, and safety evaluation of prescription drugs for children will require that the FDA and health care providers examine current practices, acknowledge their shortcomings, and consider creative solutions to the challenges associated with gathering additional data through pediatric drug research.

Keywords: prescription drugs, children, pediatric health care, pediatrics

Suggested Citation

Noah, Barbara A., Just a Spoonful of Sugar: Drug Safety for Pediatric Populations (January 1, 2009). Journal of Law Medicine and Ethics, Vol. 37, p. 280, 2009. Available at SSRN: https://ssrn.com/abstract=1983284

Barbara A. Noah (Contact Author)

Western New England University School of Law ( email )

1215 Wilbraham Road
Springfield, MA 01119
United States
413-782-1432 (Phone)

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