Drug therapy in pediatrics: a developing field


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Lisa Mathis, MD, OND Associate Director and Pediatric and Maternal Staff, Office of New Drugs, 10903 New Hampshire Avenue, Rm. 6414, Silver Spring, MD 20903, or email lisa.mathis@fda.hhs.gov.


For many years, drug therapies were not explicitly studied in the pediatric population. The lack of data forced clinicians to treat children using empiric therapy, often guessing at the treatment dose. In addition to the lack of dosing information, there was no evidence that a product would be safe and efficacious in this unique population. Because dermatologic conditions are common in children, this lack of information affected dermatologists. In 1998, a new legislation passed that encouraged drug development in pediatrics. Additional legislation followed that allowed the Food and Drug Administration the authority to require studies in pediatrics when it was anticipated that a product would be used in the pediatric population. With the new legislation and a better understanding of differences in the dose effectiveness and safety profiles of drugs in children when compared with adults, evidence-based treatment of pediatric patients is now possible.