Needs and New Policies for Medicines for Children: The FDA,United States Incentives,and International Doings

Abstract

Most prescription medicines in the United States and in other countries are not labeled with sufficient information for sensible use in the pediatric population, even though many drugs are widely used for disorders present in both children and adults. The Food and Drug Administration (FDA) has launched initiatives to get pediatric use information into labeling of medicines in the United States: a 1998 regulation requiring that drugs be studied in the pediatric population; marketing exclusivity for obtaining pediatric data; and a 1994 labeling regulation allowing use of adult safety and effectiveness data as a basis for pediatric use of drugs. Harmonization of international pediatric drug policies and regulations could increase the global availability of drugs labeled for pediatric use. The goal is greater availability worldwide of information on pediatric dosing, pharmacokinetics, and avoidance of safety problems.