One of the many provisions of the recently enacted Food and Drug Administration Modernization Act (FDAMA) provides for an additional period of market exclusivity in exchange for completed pediatric studies requested by the FDA for certain drugs of potential benefit to the pediatric population. The impetus for this law centers around two facts: Drugs needed in the pediatric population lack labeling for pediatric use, and industry lacks incentive to perform studies to support this additional labeling. Congress has now provided the incentive. The success of the pediatric initiative will rest initially on industry's willingness and readiness to do the studies. This willingness, in turn, will depend on FDAMA's impact on the economics of drug development and the availability of pediatric research capacity, both of which could be affected by the FDA's final rule on the assessment of safety and effectiveness of drugs and biologicals for pediatric patients. This rule will compel firms to conduct pediatric studies similar to the ones encouraged under FDAMA's voluntary pediatric exclusivity program. Although the Act provides for the statutory harmonization of the rule with the Act, whether the effects of the rule on the Act have been fully contemplated is a premise considered in this article. Congress too has much to contemplate as they evaluate the FDA's report, due in less than 2 years, on the public health effectiveness and economic effects of the Act's incentive program in preparation for possible FDAMA II modifications.