Commissioner McClellan sizes up Humatrope

FDA's approval of Lilly's Humatrope (somatropin) for idiopathic short stature did not involve "fundamental decisions or fundamental judgments, philosophical or otherwise, about...any psychological or philosophical issues related to short stature," Commissioner McClellan tells the National Press Club Aug. 8. "When the commissioner is 5'8", we're not going to," he joked. "There are some issues related to benefits and risks that some people may regard as cosmetic," McClellan acknowledged. "I think there was some evidence that we considered in that particular process on how this might have an impact on large issues," but "our decision was focused on, is the product safe and effective for its intended use, which is to lead to a significant increase in growth for some people at the very low end of the growth distribution chart" (1"The Pink Sheet" Aug. 4, 2003, p. 36)...