Floor Speech
Thank you, Mr. Speaker. I yield myself such time as I may consume.
Mr. Speaker, I rise in strong support of this legislation. I'm extremely proud to say that the bill before us is a product of a bipartisan effort to ensure that the Food and Drug Administration has the authority and resources it needs to ensure American consumers have timely access to safe and effective prescription drugs and medical devices. This bill accomplishes a number of important goals; first and foremost, the legislation will empower the FDA to protect patients from potentially harmful prescription drugs. Over the past few years, it has become clear that consumers have been placed in harm's way due to the failing of our current drug safety system. The legislation we're passing today will lay the groundwork for restoring public confidence in the FDA by giving it the tools it needs to safeguard the public health. There are many other significant measures included in the bill before us such as the re-authorization of two important user fee programs that will provide the FDA with the financial resources it needs to approve applications for new drugs and devices to be marketed. In addition to new funding for the pre-market actives of FDA, this bill includes a substantial amount of new funding for post market safety activity. The bill will re-authorize two important programs that will help encourage drug makers to conduct research into prescription drugs in pediatric populations. Similarly, we are providing incentives to device manufactures to develop products specifically designed by the use of children. And finally, this bill establishes the Reagan-Udall foundation to help build public-private partnerships designed to advance the mission of the FDA. I would like to thank all the Members who devoted the hours and days to developing this bill. Specifically, I would like to thank our Chairman Mr. Dingell, Ranking Member Barton, Mr. Deal, Mr. Waxman, Mr. Markey, Ms. Eshoo, Mr. Rodgers and Dr. Burgess as well - all of them - for all of their hard work, and devoted staff as well, because of all of the work the staff did and their efforts in making this bill possible. In closing, I just want to reiterate that this bill has strong bipartisan support as well as support from the pharmaceutical and medical device industries and a number of consumer advocacy organizations. Few times in the past do I recall that we have achieved such a wide ranging consensus on a bill of this size or importance and I strongly urge my colleagues to support its passage and I reserve the balance of my time. |
