FDA Milestone for Pediatric Drugs: 100 Drug Labels Have New Pediatric Information Since 19

The FDA announced that Trileptal, a drug to treat seizures, has become the 100th medicine to have new information for children and teenagers included in its labeling. Under eight years of legislation to enhance pediatric drug information, 100 pediatric drugs now include additional labeling information on safety, efficacy, dosing and unique risks for children. The Federal Food, Drug, and Cosmetic Act (as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 2002 Best Pharmaceuticals for Children Act (BPCA), provides incentives to companies who perform research to determine the safety, efficacy, dosing and unique risks associated with medications for children, based on the same level of scientific evidence required for adults. Under the law, FDA works with the larger pediatric community to determine which products should be studied in the pediatric population based on the public health needs of children. The American Academy of Pediatrics (AAP), representing the nation’s pediatricians, and the Elizabeth Glaser Pediatric AIDS Foundation have partnered with FDA to disseminate the new drug information to doctors and consumers across the country. See http://www.fda.gov/bbs/topics/NEWS/2005/NEW01280.html for a list of the 100 drugs with pediatric labeling.