Food and Drug Administration Amendments Act of 2007

Floor Speech

FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT OF 2007 -- (House of Representatives - September 19, 2007)

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Mr. BARTON of Texas. Mr. Speaker, I yield myself such time as I may consume.

(Mr. BARTON of Texas asked and was given permission to revise and extend his remarks.)

Mr. BARTON of Texas. Mr. Speaker, most of us are too young to remember, but in the early days of the movies there was a series of movies based on the ``Perils of Pauline.'' Pauline was a heroine who always got tied to the railroad track, and just as the train was bearing down on her the hero would come out and rescue her for another adventure in the next movie reel.

Well, this bill before us has kind of experienced the Perils of Pauline. It started out in a tremendous positive bipartisan spirit here in the House. Chairman Dingell and Subcommittee Chairman Pallone on the majority and Mr. Deal and myself on the minority side and our colleagues in the rank-and-file worked together. We reported a bill, and I don't remember how many votes it got on the House floor, but I believe it was over 400. It got over to the other body, and they modified it in some ways that were somewhat different than the House bill. The negotiations broke down, and it looked for a while this week that the Food and Drug Administration was going to have to send out reduction in force notices to over 2,000 employees at the Food and Drug Administration. But thanks to the tremendous leadership of Chairman Dingell and Subcommittee Chairman Pallone and the help of people like Congressman Waxman and others on the majority side, we've been able to come back together and create a unified House position and work with our friends in the other body. And they've accepted the compromise that's before us to say that here, at 3 o'clock on Wednesday afternoon, we're going to rescue Pauline and pass the PDUFA, I hope by unanimous consent on the suspension calendar, the PDUFA reauthorization bill, and lots of good things are going to happen.

I am honored to be the ranking member on the Energy and Commerce Committee, along with Subcommittee Ranking Member Deal, who has worked with the majority to put this compromise together.

I want to stress the sensitivity of completing the reauthorization of the Prescription Drug User Fee Program and the Medical Device User Fee Program right now. As I said earlier, if we were not to have done that by the end of this week, over 2,000 employees at the FDA would probably have received a reduction in force notice sometime next week or the week after. These are dedicated experts who are responsible for reviewing and approving new drugs, biologics and medical devices. If we were to lose those individuals, we would probably never get them back. That would have severe negative repercussions for everybody in this country.

The legislation before us will promote advancement in pediatric therapies both for pharmaceuticals and for medical devices. The Pediatric Rule and the Best Pharmaceuticals for Children Act have helped to fill a void in pediatric medicine. Prior to these acts, many children were not getting the best treatment because the information was simply not available to determine how a drug would act on them. Drugs do perform differently in different patients, which is especially true when that patient is a child. These acts have begun to provide physicians the information they need to make the best decisions for their pediatric patients. These two acts work together to ensure that accurate, timely pediatric use information is developed to ensure the best medical outcomes for the Nation's children.

The bill preserves the 6-month incentive that companies receive to do additional testing in pediatric populations. I want to emphasize that. The bill before us preserves the 6-month pediatric exclusivity provision in current law, and I think that's a real accomplishment. Chairman Dingell should be commended for his leadership on that effort. I was glad to support him in that insistence on that particular provision. I would also like to thank Congresswoman Anna Eshoo for her work on that provision.

Finally, the legislation addresses the issue of drug safety. No drug is completely safe. All drugs have some risk. The goal of the Food and Drug Administration is to ensure that the benefits of the drug outweigh any potential risks and ensure that patients have access to life-saving and life-improving medications.

The legislation before us today strives to ensure that the FDA has the authority to monitor drugs to ensure that the balance between the benefit and the risk remains in equilibrium. The FDA will now have the authority to require that drug sponsors conduct postmarket clinical trials. The FDA will now have the authority to require that a drug make a label change. The FDA will also now have the authority to impose additional requirements on a drug in the form of a risk evaluation and mitigation strategy when it is needed to ensure that a drug's benefits outweigh its risk.

Mr. Speaker, this bill is a bipartisan compromise that does strengthen the FDA, it will improve children's health, and it will reauthorize programs that are essential to ensuring that patients have timely access to drugs and medical devices.

Before I reserve the balance of my time, I again want to thank Chairman Dingell, Subcommittee Chairman Pallone, Ranking Member Deal, and all the rank-and-file members. I also want to especially thank Ryan Long on the minority staff, the gentleman that is sitting to my left. He stayed up all last night working on these final nuances. I shouldn't say this, but I'm told that he has the same clothes on today that he had on yesterday because he has worked so hard on this bill. We do want to give him special commendation. And I would urge that he take the appropriate hygienic provisions as soon as possible.

With that, Mr. Speaker, I reserve the balance of my time.

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