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66,632 (1998). This rule requires manufacturers to subject children to tests of a drug with a ¬foreseeable¬ pediatric use, even if the company does not intend to market the drug for such use. Petitioners object to the FDA's unprecedented assertion of authority to order manufacturers to conduct studies of products they do not wish to market. AAPS argues that the rule is an unwarranted intrusion into the practice of medicine. The ¬off-label¬ use of drugs approved for other indications is recognized as a common and integral feature of medical practice. Between 20 and 60 of prescriptions written each year are for such uses.

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