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Rogers, Markey Call for Reauthorization of Pediatric Medical Device Law

Wed, 08 Feb 2012 05:00:00 GMT

With the development of devices for children still lagging at least five to 10 years behind those for adults, today Congressmen Mike Rogers (R-Mich.) and Edward J. Markey (D-Mass.) introduced The Pediatric Medical Device Safety and Improvement Reauthorization Act of 2012 (H.R. 3975) to support the continued development of medical devices intended specifically for children.

The bipartisan legislation would reauthorize the successful 2007 law co-authored by Reps. Rogers and Markey which created 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.

"I am pleased that the 2007 law has been so successful in strengthening access to medical devices for children," said Rep. Rogers, a senior member of the House Energy and Commerce Committee. "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."

"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, also a 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."

Specifically the Pediatric Medical Device Safety and Improvement Reauthorization Act of 2012 would:

Reauthorize 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."

Rogers Praises Rescue of Hostages in Somalia

Wed, 25 Jan 2012 05:00:00 GMT

U.S. Rep. Mike Rogers, MI-08, and chairman of the House Intelligence Committee today released the following statement regarding the rescue by U.S. Special Forces of two hostages in Somalia.

"With the daring rescue of Jessica Buchanan and Poul Thisted, our intelligence professionals and special forces yet again showed the reach and determination of our nation to combat terrorism and protect our citizens and our allies. Unlike others, this nation does not negotiate with terrorists; we fight them wherever they threaten our interests and our citizens. The detailed and complex intelligence that goes into a raid like this is astounding. This event demonstrates the need to maintain a strong and flexible intelligence and military apparatus, even as we make hard choices about government spending. I commend our special forces, and our men and women on the front lines of intelligence who toil day in and day out to keep our nation and our people safe."

Rogers Statement on the President's State of the Union Address

Tue, 24 Jan 2012 05:00:00 GMT

U.S. Rep. Mike Rogers, MI-08, issued the following statement today on the president’s State of the Union address:

"Unfortunately for Michigan families, President Obama has promised a lot over the past three years but has failed to deliver. The budget deficit and national debt are at record highs, his administration is choking off American energy sources and employers continue to fear even more taxes and regulations that are already killing jobs and economic expansion.

"Taxpayers don’t need any more big government mandates that have proven to be disastrous. The president should reverse course and work with Congress on real solutions to our country’s most pressing issues, including getting government spending under control, preventing tax increases and adopting an all-of-the-above national energy strategy such as allowing the Keystone XL pipeline project to proceed.

"The country’s future can be bright, but only with bold solutions and ideas that tear down government barriers and encourage private sector job creation."

Rogers Statement on Keystone Pipeline Permit Denial

Wed, 18 Jan 2012 05:00:00 GMT

U.S. Rep. Mike Rogers, MI-08, issued the following statement after the Obama Administration formally rejected a permit to construct the Keystone XL pipeline.

"With Americans struggling to afford soaring gas prices, such a short-sighted decision will simply force the Canadians to sell their oil to China while enriching America's enemies like Iran. At a time when the Iranians are threatening to close off the Strait of Hormuz – a move that would cripple the American economy – the President just said no to 20,000 new jobs and delivered a kick in the gut to every American who commutes to work or takes their kids to school."