Advent of recombinant human growth hormone to increase final adult height of the normal child.

This commentary is motivated by the publication of the Briefing Document on the use of somatropin for non– growth hormone deficiency short stature by Eli Lily on 1 May 2003. This was followed by approval by the US Food and Drug Administration’s (FDA’s) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) on 10 June 2003, and subsequent full approval by the FDA on 25 July 2003. Eli Lily has advised the FDA that it will not engage in direct-to-consumer advertising of somatropin, and will limit the marketing of the new use of this product to paediatric endocrinologists in order to better ensure the proper use of this product in the indicated population. In addition, the manufacturer intends to tightly control its distribution.