FDA Center for Drug Evaluation and Research (CDER) Pediatric Plan and New Regulations

Abstract

The lack of appropriate pediatric information in the drug label has long been a concern for pediatricians and other clinicians who serve children, pediatric advocacy groups, regulators, drug sponsors, and academicians dedicated to clinical care and research in children. Many approved drugs are used in the pediatric population without the proper information on dosage, dosing schedules, and potential toxicities. In 1979 FDA published the first pediatric labeling regulations in an attempt to correct this problem. These regulations required sponsors to conduct clinical trials in children before including pediatric information on a drug's label. Clearly, these regulations did not produce the expected results. The new pediatric regulation published in December 1994 eases requirements for sponsors to claim pediatric uses in their drug product labeling. The agency must conclude that the course of the disease and the effects of the drug are sufficiently similar in the pediatric and adult populations to permit extrapolation from the adult efficacy data to pediatric patients. Sponsors need only to gather and analyze supporting pediatric information (eg, pharmacokinetic data, safety data) and decide whether this information provides appropriate instructions for use in the pediatric population. This regulation will hopefully provide an incentive to sponsors to gather data for inclusion in the pediatric subsection of the label. CDER will proactively work with sponsors throughout drug development in order to obtain adequate information on pediatric drug use.