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Mr. MARKEY. I thank Chairman Upton and Chairman Pitts and I thank Ranking Member Pallone and Ranking Member Waxman for their work in bringing to the floor a bipartisan bill that provides FDA additional resources to bring new drugs and medical devices to market. But today's bill is also a huge missed opportunity. It would be a disservice to patient safety to ignore the bill's major shortfall.
Many Americans would be surprised to learn that 90 percent of medical devices are not required to undergo clinical testing in human beings prior to being sold. Under current law, the FDA is required to clear certain medical devices as long as they demonstrate their similarity to an earlier product, even if the new device is modeled after a similar defective device that caused serious injury or even death. Today's bill offered an important opportunity to address this device-safety loophole, but it doesn't. The loophole remains in place, and patients are still, and will remain, at grave risk.
Four years ago, Jaye Nevarez, a 50-year-old mother of three, was a healthy truck driver who earned a decent living, played in a band, and paid her bills on time. Then her doctor implanted a bladder mesh, a device that traces its origin back to a previous product that was recalled for causing serious injury and in some cases death. Jaye now lives in constant pain. She was forced to quit her job. She can't walk without a cane. She lost her insurance and faces a growing mountain of medical debt. The bank recently began foreclosure proceedings on her home where she lives with her 79-year-old mother.
Jaye isn't the first to be harmed by this loophole. If we fail to fix it, she won't be the last. There will be tens of thousands of others who fall into this loophole who will suffer serious injury.
I introduced the SOUND Devices Act providing FDA the ability to protect the public from these unsafe devices, but this was not included in the bill. The bill we are voting on today is critically important, however. It includes the EXPERRT Act, a bill that I authored to improve communication between FDA and experts in rare diseases. It includes bipartisan provisions that I'm proud to have worked with other Members to promote, especially in pediatric-device development.
This bill must not be the last word on medical-device safety. I hope that my colleagues will join with me to close this loophole so that we can keep the American public safe from harmful medical practices.
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Mr. LYNCH. Mr. Chairman, while I strongly support some of the programs supported by this funding bill, it contains a number proposals that I believe are detrimental.
Firstly, H.R. 5854 includes language that will amount to an unwarranted extension of the pay freeze that's currently in effect for Federal employees. Specifically, sections 129, 231, and 232 would freeze the pay for Federal civilian employees across the Departments of Defense and Veterans Affairs through FY 2013 even though these employees, like all Federal employees governmentwide, have already sacrificed their fair share when it comes to reducing the Federal budget deficit. In this Congress alone, Federal employees have given up over $75 billion towards deficit reduction efforts and to offset the costs of unemployment benefits for millions of other workers.
Let us remember that our Federal employees are in the second year of a 2-year Federal pay freeze that will save the Federal Government $5 billion by the end of fiscal year 2012 and an estimated $60 billion over the next 10 years. For the average middle-income Federal employee, this will amount to a loss of approximately $47,000 in income over a 20-year period that could go toward a child's education or a family's retirement security.
Our Federal employees have already done more than their part to achieve government cost savings, and in recognition of their dedication President Obama recently proposed a modest pay raise of 0.5 percent--a half a percent--in 2013 for Federal workers. This bill, however, rejects the President's funding request for 0.5 percent for civilian employees at DOD and the VA and freezes their salaries for a third consecutive year, even though a 0.5 percent raise will still not adequately protect Federal pay from being eroded by an inflation rate that is currently over 3 percent. So they're still going to get a pay cut, but it would have been a 2 1/2 percent pay cut instead of 3 percent. And we can't live with that.
Mr. Chairman, this is yet another in a series of legislative attacks that have targeted middle class workers in this Congress. It will further erode employee morale and diminish the Federal Government's ability to attract the best and brightest to carry out its work.
I don't know if you read Politico today. They did a survey of job satisfaction among Federal employees in the VA. The docs are doing great work. The nurses are doing fantastic work. The therapists over there are. We all say we're really protective about our veterans. Well, these are the people that take care of our veterans every single day. They clean the bedpans. They do their therapy. They do their surgery. They watch out for them. And we were going to give them a 0.5 percent raise this year. Instead, what this bill does is cuts their pay. It cuts out that 0.5 percent that they would have gotten.
These are the people that are taking care of our veterans. God bless them. A lot of them are veterans themselves. And these are DOD employees. We all say we're pro-military. These are people that are supporting our fighting men and women in Iraq and Afghanistan on a daily basis in a direct way. We were going to give them a 0.5 percent raise. But no, we're going to cut their pay in order to have them help us balance the budget some more. They're already in a 2-year pay freeze.
Our dedicated civil servants play a vital role in many critical areas, especially in the work they do every day to support our military and our veterans. They should not continue to bear a disproportionate burden when it comes to addressing our Nation's budget problems.
I also want to express my strong opposition to section 517, which, again, prohibits the use of project labor agreements, as we said before.
There's a lot of disappointments in this bill. I cannot believe that we're going after VA workers in this bill and against Defense Department workers in this bill. I think they do a lot for this country. They do a lot for the most vulnerable, especially at the VA. They do heroic work there. I have three VA hospitals in my district. I'm blessed with the Brockton Hospital. They're doing tremendous work there with a lot of our World War II veterans, who, for the first time in their lives, have to rely on the VA.
And these are the people that are doing that job, Mr. Chairman. They're doing a tremendous job. They're already working at less wages than they could get at a private hospital. But because they love our veterans and believe in it, they stay there at the VA out of the goodness of their heart. And now we've got them in a 2-year pay freeze. The President was trying to give them a 0.5 percent increase in cost of living, and they're being denied even that.
I yield back the balance of my time.