Political Quotes

“today we are considering a bill that will improve the FDA's ability to assure the safety of drugs in our medicine cabinets and medical devices in our hospitals. The FDA is an essential guardian of the public's health and safety. In the past few years, FDA has faced obstacles that call on the agency to adapt and respond to the evolving nature of reviewing, manufacturing, and distributing drugs and devices. Some of those obstacles and challenges are addressed in the reauthorizations of the Prescription Drug User Fee Act and the Medical Device User Fee Act, which are set to expire at the end of September 2012. Last fall, I visited Cook Medical's medical device plant in Canton, Illinois, and representatives expressed concern about the amount of time it takes medical devices to be reviewed. The FDA needs sufficient time to review medical devices, in order to ensure their safety and effectiveness. However, inefficiencies and insufficient resources can result in longer review times, which mean patients have to wait longer to benefit from new medical devices. This bill makes key changes to maintain the safety of devices and preserve our country's leadership in biomedical innovation. The bill will authorize the FDA to collect almost $600 million in user fees over 5 years. The FDA can use these additional resources to help hire and train staff.…”