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Peter P. Budetti, MD, JD

JAMA. 2003;290:950-951.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

Pediatricians and other child health professionals routinely treat children with medications that have not been proven to be safe and effective for their patient population and that have labels that lack appropriate guidance from the manufacturer on how those drugs should be used for children. Shocking? Perhaps. But in reality those who provide medical care to children have little choice because, as noted in the article by Roberts et al¹ in this issue of THE JOURNAL, "only one third of drugs used to treat children have been studied adequately in the population in which they are being used and have appropriate use information on the product label. For the other two thirds of drugs, information regarding safety and efficacy for pediatric patients is insufficient or absent."

Under the Federal Food, Drug and Cosmetic Act,² the Food and Drug Administration (FDA) must approve new medications as . . . [Full Text of this Article]

Author Affiliations: Department of Health Administration and Policy, College of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City.

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