Potential Benefits of Pediatric Information: Background Paper

This analysis examines the potential benefits of new regulations the FDA is preparing to issue which would require pediatric studies of certain new and marketed drug and biological products. The regulations address two major problems associated with the lack of adequate information on the effects of drugs on pediatric patients: (1) frequent adverse drug reactions in children due to inadvertent drug overdoses or other drug administration problems that could be avoided with better information on appropriate pediatric use, and (2) frequent underuse of safe and effective drugs for children, due to the prescribing of an inadequate dosage or regimen, a less effective drug, or no drug at all, because of uncertainty over its effect on children or the lack of a pediatric formulation. By developing improved information on whether, and in what dosage, a drug is safe and effective for use in children, FDA believes that the regulation will result in fewer adverse drug reactions and fewer instances of less-than-optimal treatment of pediatric patients.

AGENCY SPONSOR: Office of Planning, Policy & Legislation

FEDERAL CONTACT: Braslow, Lawrence

PIC ID: 7272

PERFORMER: Food and Drug Administration
Rockville MD