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Public Statements

Food And Drug Administration AMendments Act Of 2007

Floor Speech

Location: Washington, DC

FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT OF 2007 -- (House of Representatives - July 11, 2007)


Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I rise in strong support of this legislation. I am 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 that 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 are 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 reauthorization 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 review activities of FDA, this bill includes a substantial amount of new funding for post-market safety activities.

The bill will also reauthorize two important programs that will help encourage drug makers to conduct research into the appropriate use of prescription drugs in pediatric populations. Similarly, we are providing new incentives to device manufacturers to develop products that are specifically designed for use in children. Finally, this bill establishes the Reagan-Udall Foundation, which will help build public-private partnerships designed to advance the mission of the FDA.

I would like to thank all the Members who devoted so many hours and days to developing this bill. Specifically, I would like to thank Chairman Dingell, Ranking Member Barton, Mr. Deal, Mr. Waxman, Mr. Markey, Ms. Eshoo, Mr. Rogers and Dr. Burgess, as well, all of them, for their hard work and devoted staff, as well, because of all the support that the staff did in their efforts in making this bill possible.

In closing, I would just like 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. I strongly urge my colleagues to support its passage.


Mr. PALLONE. Mr. Speaker, before we proceed to the vote on H.R. 2900, I yield myself time to acknowledge the months of work that Members have done leading to this bill coming before the House today. It truly was a bipartisan effort, and everyone worked so hard.

I also wish to take a moment to recognize the efforts of the staff who worked long hours in ensuring we produced a quality piece of legislation. In particular, I thank Warren Burke and Ellen Sutherland, professional staff with the Office of Legislative Counsel, for their outstanding service.

I also want to thank the staff of the Committee on Energy and Commerce. I'm not going to mention the Republicans, not because they didn't do as much work, because they certainly did, but I don't remember all their names. I don't want to eliminate anybody.

As far as the Democratic staff is concerned, I do want to specifically mention John Ford, Pete Goodloe, Jack Maniko, Melissa Sidman, Jessica McNiece, Bob Clark and Virgil Miller. And from Mr. Waxman's staff, because Mr. Waxman and Mr. Markey played a major role in this bill and Mr. Waxman's staff in particular, Karen Nelson, Rachel Sher and Stephen Cha. And again, everyone worked very hard on this.

I think it is really remarkable that we were able to achieve a consensus and bring this up today, particularly under suspension.


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