As a grandfather of a precocious and precious 2-year old, this week’s Senate HELP Committee hearing on the importance of pediatric medicines was of great interest to me. We all hope and pray that our children and grandchildren never need prescription medicines, but the fact is children, just like adults, get sick and require unique treatments.

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.� This has led to new labeling in more than 120 new or approved drugs for use in children. In comparison, between 1990 and 1997, before the law was enacted, only 11 products were studied in children, according to a recent article in JAMA.

The pediatric exclusivity program has allowed for public health benefits that are undeniable. According to the American Academy of Pediatrics, “Pediatricians are now armed with more information about which drugs work and at what doses.� Requests for studies have been made in a wide range of therapeutic areas, including treatment of fever, skin conditions, heart disease, HIV, cancer, endocrine problems, gastrointestinal disorders and others.

Clearly, this program has had a tremendously positive impact on the lives of children across America. For this reason, Congress should reauthorize BPCA, leaving its basic features unaltered.

This entry was posted on Thursday, March 29th, 2007 at 3:47 pm and is filed under Politics, Healthcare .