A Prescription for a Healthy Childhood: A History of Children and Pharmaceuticals in the United States

Award Year: 2009	Investigator: Cynthia Connolly	Budget: $334,552	Categories: Pharmaceutical Policy, Child Health
Abstract: The growing use of pharmaceuticals in children raises complex and troubling policy issues. How can we conduct research on safety and efficacy, ensure patient safety, provide access to promising treatments, and encourage private sector innovation and product development, all the while protecting children? Cynthia A. Connolly, Ph.D., R.N., P.N.P., an associate professor of nursing at the University of Pennsylvania, probes the many dimensions of this dilemma through a historical lens. Her project, A Prescription for Healthy Childhood: A History of Children and Pharmaceuticals in the United States, addresses four major health policy issues: how beliefs about children and their place in American society informed policy debates surrounding pharmaceuticals for children; how stakeholders have responded to debates about use, testing, advertising, and regulation of pharmaceuticals for children; how ideas about children's best interests shifted over time and shaped health policy; and how politics and legislative and regulatory choices led to reforms with both intended and unintended consequences. Dr. Connolly's findings will shed light on current controversies such as the escalating use of behavioral drugs in children, off-label prescribing of anti-depressants, use of over-the-counter products, and the appropriate role of drug studies on children to ensure safety and efficacy. Her research should help expand our understanding of the costs, benefits, risks, coverage, and access issues associated with children's pharmaceuticals.