By Dr. Alan Goldhammer, Deputy Director for Regulatory Affairs, Pharmaceutical Research Manufacturers of America
That’s why it is critically important that the Best Pharmaceuticals for Children Act (BPCA) be reauthorized. This program has greatly advanced pediatric medical care by providing a voluntary incentive to America’s pharmaceutical research companies for conducting pediatric studies of medicines that the Food and Drug Administration (FDA) determines may be useful to children.
Studying drug therapies in children is highly specialized work. According to the Tufts Center for the Study of Drug Development, the cost, length and complexity of pediatric studies have expanded significantly since 2000 Despite that trend, FDA data show companies are still investing and engaging in this important research and responding to FDA written requests at very high numbers.
BPCA has helped spur research and, according to the Food and Drug Administration, has helped generate more critical information about the use of medicines in pediatric patients than any other government initiative. For example, according to the Tufts Center for the Study of Drug Development, “by the end of 2006, FDA had issued 336 written requests for 782 pediatric studies involving 46,000 children.