FDA NEWS RELEASE

FDA Joins Children's Health Groups to Mark Historic Milestone for Pediatric Drugs
100 Drug Labels Have New Pediatric Information Since 1997

The Food and Drug Administration (FDA) announced today 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.

"This is a highly gratifying achievement for our most precious patients, their parents, and their physicians," said Acting FDA Commissioner Dr. Andrew von Eschenbach. "This initiative highlights our agency's efforts to continue to improve the quality of information available about medications."

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.

"Pediatricians are now armed with more information about which drugs work and at what doses," said AAP President Eileen M. Ouellette, MD, JD. "In some instances, we found out we weren't giving enough medicine to be effective. We also learned when some drugs don't work or have potential safety concerns only associated with their use in children. The law that generated this drug information is truly making a difference in patient care."

"The law creating these incentives has resulted in an unprecedented surge in the number of drugs tested in children," said Mark Isaac, vice president of the Elizabeth Glaser Pediatric AIDS Foundation. "Since 1997, we've seen a 20-fold increase in critically-needed pediatric studies compared to the same period before that. The incentives are proven to deliver life-saving health information for children--the same information that we expect and demand for ourselves as adults."

FDA has issued more than 300 requests for studies of medications, based on either the frequent use or the potential use of those medicines in the treatment of children, or on the need for pediatric information so the drugs may be used to treat disorders for which children have few or no other options. Since FDAMA was enacted in 1997, manufacturers have conducted more than 250 pediatric studies for 125 products. By comparison, in the 7-year period before FDAMA was enacted only 11 such studies were conducted. The studies from 114 products responded to the requests by FDA and these products have been granted six months of additional marketing without generic competition.

"The studies were conducted for a wide range of childhood conditions, such as asthma, HIV, seizures, juvenile rheumatoid arthritis, pain management, diabetes, high blood pressure, attention deficit hyperactivity disorder, brain tumors and leukemia," said Steven Galson, MD, Director of FDA's Center for Drug Evaluation and Research. "They have resulted in important new pediatric information in 100 new drug labels and additional drugs are presently being studied to further protect our children from any serious side effects."

"Because of FDAMA/BPCA and so many in the pediatric academic and advocacy community, significant progress has been made to provide better information on how to use medicines more effectively and safely in children," said FDA Deputy Commissioner Murray Lumpkin, MD. "Much more remains to be done, but these studies clearly indicate that children need their own studies if we are to have the information needed for parents and practitioners to provide appropriate safe and effective therapies to our children."

For a list of the 100 drugs with pediatric labeling, see: www.fda.gov/cder/pediatric/labelchange.htm.

For information on AAP, see: www.aap.org.

For information on the Elizabeth Glaser Pediatric AIDS Foundation, see: www.pedaids.org.

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