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.

Keywords

Pediatric FDA International Clinical study

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References

Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients. Federal Register. 1998;63:66632.

Food and Drug Administration Modernization Act of 1997. Pub Law 105–115 (1997 Nov 21); 21 USC 355a; 111 Stat 2296.

Specific requirements on content and format of labeling for human prescription drugs: Revision of the “pediatric use” subsection in the labeling. Federal Register. 1994;59:64240.