work encompasses many of the leading pediatric clinical pharmacologists at universities and children's hospitals in the United States. Thus, it can draw on the data from the more than 200,000 in patient and 2 million pediatric outpatient visits each year.

Role of Insurance and Managed Care Organizations

In some areas of the United States, health insurance providers report spending more on pharmaceutical coverage than in patient hospital services. In trying to address the rapidly growing cost of prescription pharmaceuticals, some insurers and managed care organizations have begun to develop more restrictive formularies, basically applying tiered payments to offer incentives for the purchase of preferred pharmaceuticals. Thus, insurers have an interest in encouraging safe and efficient clinical testing of drugs for use by the pediatric population. One way of building on the incentives already being supplied through FDAMA would be to encourage the use of pharmaceuticals that have received guidance and labeling instructions for administration to pediatric patients. Some have suggested that third party payers should perhaps stop paying for either off-label or innovative interventions unless they are used as part of a well designed, controlled, and adequate study. Other providers have established policies that do not deny payment to any patient participating in any phase I through IV clinical trials. In New Jersey, for example, insurance and managed care organizations have agreed not to exclude patients from coverage for health care needed because of participation in certain phases of clinical trials. Standard contracts often exclude patients from coverage when they participate in clinical trials.

Legal Concerns

Legal questions remain: What will the effect of the mandatory study rule be, particularly for marketed products? Will the FDAMA incentive be renewed after its initial impact is evaluated?

International Issues

Although the ethics of research with children will always differ among cultures and nations, the fundamental principles of how such research should be done can be developed. In any event, ethical issues should be openly discussed. The World Medical Association and the American Medical Association have established a task force to receive and review input on the Helsinki Declaration in an effort to achieve some standardization of basic ethical principles for research with humans.

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