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U. of Michigan report looks at pediatric FDA approvals


ANN ARBOR, Mich. According to a University of Michigan report released earlier this week, only 90 percent of prescription medicines used in adults have been Food-and-Drug-Administration approved, with the remaining 10 percent accounting for off-label prescribing. Moreover, the University report charged that out of the entire universe of prescription-drugs, only 30 percent have been approved for use in pediatric populations. The report did not include data regarding the overall percentage of medicines actually prescribed to children, however, nor how that data might correspond to the 30 percent of medicines bearing a pediatric usage label.

The report did include a December 2007 C.S. Mott Children’s Hospital National Poll on Children’s Health which gauged parent’s knowledge on whether or not they knew the prescription drugs being prescribed to their children were being prescribed via FDA label guidelines or as an off-label use for a particular medicine. According to the survey, 83 percent of parents believed the last medicine prescribed for their child had FDA approval for use in children, and 77 percent of parents would prefer that their doctors not prescribe a medicine in an off-label capacity to their children. That number did not change when parents were informed that only 30 percent of all medicines, including medicines for disease-states more often associated with adult diagnoses, such as erectile dysfunction, menopause or contraception, for example, have been approved for use in children.

The majority of parents, 94 percent, expected the doctor to tell them whether or not a medicine is being prescribed per its labeling or if the doctor is suggesting an off-label use of the medicine.

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