
Originally Posted by
FDA
Up until the last decade, children were rarely included in studies of medical treatments. As a result, much is still unknown about how children respond to drugs, some biologics (such as gene therapy), and medical devices."We had the peculiar situation of demanding a very high level of proof before a product was marketed for adults, but then having it used 'off-label' in children," says Dianne Murphy, M.D., Director of the Office of Pediatric Therapeutics at the Food and Drug Administration (FDA). This means that FDA did not have studies on how the product did or did not work in children, what different kinds of reactions children might have, or what the proper dose would be over the wide range of children's ages, weights, and developmental stages, Murphy says.