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Executive Summary

In 1997, as part of the Food and Drug Administration Modernization Act (FDAMA) (Pub. L. 105-115), Congress enacted a new law that provides marketing incentives to manufacturers who conduct studies of drugs in children.  This law, which provides six months exclusivity in return for conducting pediatric studies, is commonly known as the pediatric exclusivity provision. The pediatric exclusivity provision has a sunset date of January 1, 2002, and includes a requirement that the Secretary report by January 1, 2001, on the experiences under the new law. This report is submitted in accordance with that requirement.

As described in this report, the pediatric exclusivity provision has been highly effective in generating pediatric studies on many drugs and in providing useful new information in product labeling. Some categories of drugs and some age groups remain inadequately studied, however, despite the new incentives. The Secretary has provided suggestions for modifications to the pediatric exclusivity provision that may address these gaps.