Alexander Urges Action on Legislation to Improve Safety of Pediatric Medicine

Reauthorization, New Bill Aimed at Pharmaceuticals, Devices for Children

Posted on March 27, 2007

U.S. Senator Lamar Alexander today urged his colleagues to act quickly on legislation aimed at increasing the research and development of medical products specifically for use on children, citing a group of Tennessee babies who required surgery in 1999 after receiving an antibiotic that had never been tested on young children. The Best Pharmaceuticals for Children Act of 1997, which expires this year, was designed to encourage the study of how medicines react specifically in children. “For 10 years this law has helped provide worried parents and concerned physicians with information they need to make better decisions in prescribing treatment for young children,” Alexander said. “By extending drug patents in exchange for additional research on how these drugs affect children, this program has prompted studies on 144 products and led to 122 label changes on some of the most frequently prescribed drugs for children. Clearly the system works and should be continued, especially since only a third of drugs prescribed to children have yet been studied and labeled for children.” Seven Tennessee babies who were prescribed an antibiotic to treat whooping cough in 1999 became so seriously ill that they needed stomach surgery. The Centers for Disease Control linked their illness to the antibiotic, which had never been tested in young children. The Pediatric Medical Device Safety and Improvement Act of 2007 would encourage manufacturers to bring more pediatric devices to market by: Allowing manufacturers to earn profits from humanitarian device exemptions (HDE’s) for devices specifically designed to meet a pediatric need and affecting fewer than 4,000 children per year. Currently manufacturers are not allowed to profit from these devices. Promoting pediatric device development, including “matchmaking” between inventors and manufacturers and linking innovators and physicians with existing federal resources. Giving FDA’s Pediatric Advisory Committee authority to monitor pediatric devices and address availability and safety. “Children differ widely in sizes and growth rates, so doctors often must either ‘jerry-rig’ smaller versions of devices or simply use a more invasive treatment because they lack an alternative,” Alexander said. ““Doctors should have better options.”