Political Quotes

“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.…”