For Immediate Release:	February 8, 2007
For More Information:	Ashley Wolfington, Elizabeth Glaser Pediatric AIDS Foundation, ashley@pedaids.org, 202-296-9165
Sponsor Organization:	Elizabeth Glaser Pediatric AIDS Foundation
Duke University Study Published in JAMA Finds Children Gain from Incentive Program
Washington, D.C.—February 6, 2007—A study conducted by professors of medicine, economics and business at Duke University and published in the February 7 issue of the Journal of the American Medical Association concludes that a law creating incentives to drug companies to test certain products in children has produced major medical benefits. The findings are a powerful affirmation of the Best Pharmaceuticals for Children Act (BPCA), a law that offers a six-month patent extension for companies that conduct pediatric studies. The authors conclude that the greatest benefit of the program is the valuable data generated by the pediatric studies. The JAMA study also found that BPCA patent extensions for high volume "blockbuster" drugs netted large profits for their manufacturers after factoring in the costs of pediatric studies, but that extensions for most drugs netted far more modest profits or even resulted in small losses. “We still owe children a lot of information about the medicines they take every day,” said Pamela W. Barnes, president and CEO of the Elizabeth Glaser Pediatric AIDS Foundation. “We urge lawmakers to remember how important these studies are for children's health and to preserve the incentive program. While our number one priority is to generate studies that tell us how these products work in children, we should also address the windfall profits associated with some blockbuster drugs.” This year, Congress will consider reauthorizing two groundbreaking laws, BPCA, last renewed in 2002 creates an incentive to conduct pediatric studies, and the Pediatric Research Equity Act (PREA), first enacted in 2003, requires that pediatric studies of certain drugs be done. Taken together, these bills have created an effective “carrot and stick” approach to pediatric testing, offering dramatic and unprecedented benefits. The dual approach has dramatically increased the number of drugs tested for use in children, giving physicians important tools with which to treat children suffering from a variety of illnesses and conditions. In the ten years since BPCA was enacted, it has generated 336 requests from the Food & Drug Administration to industry for more than 780 pediatric studies. So far, studies have been completed on more than 132 medications, resulting in changes to more than 115 drug labels to incorporate new pediatric information. “Data generated by BPCA and PREA shows us the danger of assuming a drug that is safe in adults also will be safe in children,” said Diane E. Thompson, vice president of the Elizabeth Glaser Pediatric AIDS Foundation. “Of the 59 drugs examined in the JAMA study, one-third of them were being dosed incorrectly in children before pediatric studies prompted by BPCA. We know these laws are working to provide doctors with information that saves children’s lives and Congress should waste no time in reauthorizing them.” For more information on the results of pediatric drug testing laws, including a list of products that have been found to work differently in children, visit http://www.pedaids.org . # # # About the Elizabeth Glaser Pediatric AIDS Foundation - The Elizabeth Glaser Pediatric AIDS Foundation is the worldwide leader in the fight against pediatric AIDS. The Foundation’s innovative research programs, collaborative training initiatives, advocacy efforts, and rapidly expanding international prevention and treatment programs are bringing hope to the lives of children and families affected by AIDS worldwide. To learn more about the Foundation and its programs, visit the Web site at http://www.pedaids.org .