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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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