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Public Statements

Food and Drug Administration Safety and Innovation Act

Floor Speech

Location: Washington, DC


Mr. PALLONE. Thank you, Chairman WAXMAN.

I want to say I'm very proud to support the bill before us, which would reauthorize and revitalize a number of different programs at the FDA.

This bill really represents a great compromise between the House and the Senate and strikes the right balance by including strong provisions that will be good for both innovation and patient safety.

When we passed the House version of this bill, I spoke highly of a great cordial process, and I'm happy to be able to echo those sentiments again here today. This process should be a model for congressional bipartisan cooperation in the future. Not only did we all work so well together, staffs were able to rectify the differences among the two Chambers' versions of the bill in a matter of 2 weeks. That's commendable. It's a clear indication that Congress is certainly capable of greatness if we just allow ourselves to set politics aside and simply legislate.

I want to thank Chairman Upton and Ranking Member Waxman for your leadership. And to all the staff who worked around the clock--and of course particularly Tiffany Guarascio, who is my staff person--they were all dedicated to achieving a comprehensive and consensus product, and they've done just that.

The bill before us today provides the FDA with more than $6 billion over 5 years to pay for the timely and efficient reviews of medical products. Together, these agreements will ensure that Americans have access to safe and effective new medicines and medical devices. It will reduce the drug costs for consumers by speeding the approval of lower cost generic drugs with the establishment of a new user fee program for generic drugs and for lower cost versions of biotech drugs as well.

It also includes promising provisions that address the safety of the supply chain, help to foster the development and safe use of prescription drugs for children, increase efforts to address drug shortages, change conflict of interest rules so that the FDA has access to the best expertise on their advisory panels, and other provisions which are important to the pubic health of our Nation.

This bill is good for the FDA; it's good for industry; it's good for patients alike. I'm confident we will pass this critical bill overwhelmingly today and that the Senate will act early next week so we can send it to the President for his signature as soon as possible.

I urge all Members to support this bill, and I reserve the balance of my time.


Mr. PALLONE. Thank you, Mr. Speaker. I won't use all the time.

I just want to stress, again, that the process of getting this bill passed and moved both here and in the Senate has been just a great model, if you will, for what we can do when we want to get together and work together on a bipartisan, bicameral basis. So I can't say enough about everyone who was involved on both sides of the aisle and staff for making this happen today.

I also want to reiterate some of the things that some of my colleagues have said about how important this is. Because it's on a suspension, some people may say, Well, how important is it? It is extremely important. And some of those sentiments have been echoed by those who talk about the drug and medical device industry, which is really so important to this country.

We pride ourselves on innovation. As some of you know, many of these companies are in my district. And we pride ourselves on the fact that Thomas Edison had his lab at Menlo Park, in my district, and that we are an innovative area in New Jersey, and New Jersey as a whole. But innovation can't continue to happen in this industry unless we continue to have an FDA process that runs smoothly and effectively.

The fact of the matter is that this legislation is designed to make sure that that continues to happen, that the money is available so we can have an efficient process that continues to make the United States the innovator in the area of pharmaceuticals and medical devices.

I'm very proud to have been part of this today. I urge everyone to support the bill. I thank my colleagues.

I yield back the balance of my time.


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