The results of all pediatric studies -- positive and negative -- are incorporated into labeling. If a company demonstrates efficacy, it is reflected in the labeling and the company may be granted a new indication. If efficacy is not demonstrated, that information is also put into the labeling. Pediatric safety data are presented publicly to an outside advisory committee one year after the labeling has been changed.
In 2007, PREA was reauthorized, and changes included mandates to make the approval process more transparent and publicly available. PREA has been very successful in obtaining information about medications for pediatric patients. Under PREA, there have been more than 450 postmarketing requirements for pediatric studies through the end of 2010. The labeling changes that resulted from these data can be found at: http://www.fda.gov/downloads/ScienceResearch/Special Topics/PediatricTherapeuticsResearch/UCM163159.pdf.