Leading Children’s Health Groups Laud Senate for Funding Pediatric Medical Devices in FY09 Budget

3/10/2009

Initial Two Million Dollar Investment Can Help Save Young Lives, Experts Say

Washington, D.C.—With development of pediatric medical devices lagging five to ten years behind those for adults, some of the nation’s leading children’s health groups praised Congress for providing significant funding to spur the creation of devices that are safe and effective for children. The American Academy of Pediatrics (AAP), Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), National Organization for Rare Disorders (NORD), and the American Thoracic Society (ATS) led the successful effort to encourage Congress to include funds for this important initiative.

The omnibus spending bill, passed by the Senate today, contains $2 million for development of pediatric devices. It is the first-ever appropriation for demonstration grants for improving pediatric device availability, as authorized by the Food and Drug Administration Amendments Act of 2007.

In a letter last year to Senate colleagues, U.S. Senators Christopher J. Dodd (D-CT), Edward M. Kennedy (D-MA) and Orrin Hatch (R-UT) – as well as Secretary of State and former Senator Hillary Rodham Clinton – urged the Senate to secure these federal funds for the development of children’s medical devices.

The funds will be used to provide grants to nonprofit pediatric medical device consortia, which will give scientists and innovators technical and financial resources to improve the number of medical devices available to children. The Office of Orphan Products Development will be responsible for administering these grants.

“This investment can help save children’s lives,” said Pamela W. Barnes, Elizabeth Glaser Pediatric AIDS Foundation president and CEO. “Children are often left behind in the development of new drugs and medical devices that are suited to their particular needs. The funds authorized by this omnibus spending bill can spark innovations that will help them live longer and healthier lives.”

“Children differ from adults in size, growth, development, and body chemistry, creating major challenges for scientists who are creating medical devices for the pediatric population,” said Dr. David T. Tayloe, Jr., FAAP, president, American Academy of Pediatrics. “It is vitally important that children are not just an afterthought as new devices are developed, and this funding will help make this a reality.”

“Children deserve the best medical care we can provide,” said Peter L. Saltonstall, president and CEO of the National Organization for Rare Disorders. “These congressional champions did a wonderful service by pressing for this funding. It will create greater cooperation that will allow device manufacturers to focus on children, and make it possible for more kids to benefit from lifesaving innovations in medical device technology.”

“Due to the reduced market size, many important and breakthrough respiratory devices — including ventilators, sleep apnea machines and masks – are not available to children,” said Dr. Ann C. Halbower, director of Pediatric Sleep Research
at the Children’s Hospital and University of Colorado School of Medicine, and a representative of the American Thoracic Society. “This funding will help remove barriers that exist to bringing pediatric medical device products to market, which is crucial for improving care for children living with respiratory illnesses.”

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The American Academy of Pediatrics (AAP) is an organization of 60,000 primary care pediatricians, pediatric medical subspecialists and pediatric surgical specialists dedicated to the health, safety and well being of infants, children, adolescents and young adults. (www.aap.org)

The Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) is a worldwide leader in the fight against pediatric AIDS. Its innovative research programs, collaborative training initiatives, advocacy efforts, and rapidly expanding international prevention and treatment programs are bringing dramatic changes to the lives of children worldwide. (www.pedaids.org)

The National Organization for Rare Disorders (NORD) represents the 25 to 30 million Americans affected by rare diseases. NORD is the primary organization providing advocacy, education, research, and patient services for the rare disease community on the national level. (www.rarediseases.org)

The American Thoracic Society (ATS) represents more than 13,000 physicians, researchers, and allied health professionals, who are actively engaged in the diagnosis, treatment and research of respiratory disease, sleep disorders, and critical care medicine. (www.thoracic.org)