Markey, Rogers Call for Reauthorization of Pediatric Medical Device Safety Act

Legislation speeds development of life-saving devices for children
WASHINGTON, D.C. – With the development of devices for children still lagging at least five to ten years behind those for adults, today Congressman Edward J. Markey (D-Mass.) and Mike Rogers (R-Mich.) introduced The Pediatric Medical Device Safety and Improvement Reauthorization Act of 2012 to support the continued development of medical devices intended specifically for children. The bipartisan legislation would reauthorize the original 2007 law co-authored by Reps. Markey and Rogers and includes a grant program to bring scientists and innovators together to hasten the development of pediatric devices. The bill also incentivizes the development of devices that serve children with rare conditions. Many important technologies remain unavailable for kids because there is a much smaller market for pediatric devices and children pose unique medical challenges. Rep. Markey and Rogers’ bill helps to close that gap.
Children are not simply smaller-sized adults, and their size, physique, and activity level means that their medical needs are very different from our own,” said Rep. Markey, senior member of the House Energy and Commerce Committee. “Just as kids need car seats in the car while adults use seat belts, children require medical devices that are designed to work for them to keep them safe. Our original law has made good progress helping children get medical devices that are made uniquely for them, but there is more work to do. Without this reauthorization, we risk losing the incentives and innovation occurring now in support of developing these life-saving devices.”
“I am pleased that the 2007 law has been so successful in strengthening access to medical devices for children,” said Rep. Rogers. “Kids have unique medical needs that are difficult to address, and reauthorization of this law will be critical to ensuring that kids can receive the same kind of breakthrough devices that adults do.”
Specifically the Pediatric Medical Device Safety and Improvement Reauthorization Act of 2012:
Includes a grant program to support development of devices for children. The program provides grants to non-profits that bring scientists and innovators together with device companies and regulatory experts to help get medical devices to pediatric patients as quickly as possible. These networks – known as “pediatric medical device consortia” - support device innovators and help them navigate the device approval process, thereby speeding the development, productions, approval and distribution of pediatric medical devices. Pediatricians and pediatric surgeons often have ideas for devices that could help them do their jobs and improve the health of children, but they are unsure how to navigate the device approval and patent process. The consortia provide a support network to bring these good ideas to life. One of these consortia is the Pediatric Cardiovascular Device Consortium at Children’s Hospital Boston, which develops devices for children with heart conditions.
Encourages the development of devices that serve children with rare conditions. These devices, known as “Humanitarian Use Devices” (HUDs), treat diseases that have 4,000 or fewer patients per year. Generally, companies cannot earn a profit on HUDs, because these devices go through a less stringent approval process. The bill allows devices intended for use in pediatric patients to earn a profit. Because of the tiny market for such devices, companies would otherwise have zero financial incentive to develop devices in this space.
The consortia and HUD profit cap exemption began in 2007, under Reps. Markey and Rogers’ original law. To date, the consortia have provided support to more than 130 pediatric medical devices.
The legislation is endorsed by the American Academy of Pediatrics (AAP), Massachusetts Medical Society, and Elizabeth Glazer Pediatric AIDS Foundation.
“The American Academy of Pediatrics strongly supports the Pediatric Medical Device Safety and Improvement Reauthorization Act of 2012,” said Robert W. Block, MD, FAAP, president, AAP. “Children are not just small adults and they need safe medical devices that are specifically designed for their use. Pediatricians and pediatric surgeons know the challenges to providing care to children when appropriate devices are not available. This legislation reauthorizes important and effective initiatives that were created as part of the Pediatric Medical Device Safety and Improvement Act of 2007. We are pleased that Representatives Rogers and Markey share our commitment to improving the health and well-being of children, and we look forward to working together as this important legislation moves through Congress.”