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On July 26, 2003, the federal Food and Drug Administration approved a supplemental new drug application by Eli Lilly & Company for the use of human growth hormone to treat children who are healthy but unusually short (defined as an adult height of less than 5 feet 3 inches for men and 4 feet 11 inches for women) without a known cause. This approval makes rGH available to short children who may suffer from, but cannot demonstrate, a medical condition that is responsible for short stature.
The FDA based its decision on studies that found the biosynthesized hormone Humatrope added between one and three inches in height to children who took it for four to six years, and that there were no significant health risks for the children. The FDA decision followed the recommendation of an advisory panel last month that voted 8 to 2 in favor of approving the new usage of the drug. The approval could significantly increase the number of children who receive rGH, which can cost $30,000 to $40,000 a year. The effect of the expanded use of rGH on its cost to patients and on insurance coverage is not yet clear. The medical profession is split on this expansion of the use of rGH. Critics argue that the expanded use of rGH is likely to be misused for non-health reasons.
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