Political Quotes

“Mr. Speaker, I rise today in support of H.R. 2430, the FDA Reauthorization Act of 2017 to reauthorize four important user fee programs: the Prescription Drug User Fee Act, the Medical Device User Fee Act, the Generic Drug User Fee Act, and the Biosimilar User Fee Act. These critically important laws have improved patient access to important therapies and expedited the FDA's approval times while upholding the most rigorous standards for patient safety. The Prescription Drug User Fee Act (PDUFA) was enacted in 1992 when drug review times were lagging and FDA simply couldn't keep up with the flood of new drug applications. Through user fees paid by applicants, PDUFA gave FDA the resources it needed to hire and support more staff. The program has been successful in reducing review-time backlogs and expediting safe and effective therapies to patients. My legislation created the Medical Device User Fee Act (MDUFA), which was enacted in 2002 and has resulted in significant changes to the medical device industry and within the medical device center at the FDA. Through this user fee program, the device center has improved its efficiency and reduced the time it takes to bring effective medical devices to market. This legislation builds on the progress made in previous user fee agreements and will produce important developments for the medical device industry.…”