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Food and Drug Administration Safety and Innovation Act--Motion to Proceed--Resume

Floor Speech

By:
Date:
Location: Washington, DC

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Mr. ROBERTS. Mr. President, I rise today to speak on the legislation that is actually before us as opposed to the topic before, the Food and Drug Administration Safety and Innovation Act that we are currently debating. In addition to reauthorizing the user-fee agreements, this legislation includes many other important provisions. Members should know what is in this bill and how important these provisions are.

There is language to permanently reauthorize pediatric research incentives, programs to incentivize antibiotic research and development, and more transparency and accountability for the FDA and stakeholders, which we hope will help to address drug shortages. That is a big problem not only in urban areas but in the rural health care delivery system in every State. Every Senator ought to be aware of that, and I am sure they are hearing about it.

In May I joined with Senators Reed, Murray, and Alexander in introducing the Better Pharmaceuticals and Devices for Children Act, the BPDCA. I don't think that makes a very good acronym, so I am not even going to try it. Back in 1997 Congress passed the Best Pharmaceuticals for Children Act, which acknowledged the importance of ensuring medications were effective and safe for children by providing an incentive for pharmaceutical companies to invest in pediatric research. In 2003, with the passage of the Pediatric Research Equity Act, Congress required the pharmaceutical companies to engage in these studies.

These bills are often referred to as the carrot-and-the-stick approach for pediatric drug development. I prefer carrots to sticks around here, especially mandates, but they have proven over time to work--the carrot-and-the-stick approach. Since the enactment of these laws, approximately 426 drug labels have been revised with important pediatric information, and the number of off-label drugs used in children has declined from 80 to 50 percent. That is certainly good news.

In 2007 a complementary initiative to promote the development of pediatric medical devices; that is, the Pediatric Medical Device Safety and Improvement Act, was enacted. This law has resulted in a fivefold increase in the number of small-market medical devices designated for pediatric use.

The Better Pharmaceuticals and Devices for Children Act will permanently extend these worthwhile programs, while providing some real predictability and accountability for pediatric drug and medical device development.

The legislation also includes the Generating Antibiotic Incentives Now Act that I joined with Senators Blumenthal and Corker in supporting last year. This title contains provisions that aim to boost development of products to treat serious and life-threatening infections--something that is a growing problem in all of our hospitals. It provides meaningful market incentives and reduces--get this--reduces regulatory burdens. Glory be. Here is a bill that actually reduces regulatory burdens to encourage development of new antibiotics. Why? Well, the antibiotic pipeline has slowed to an alarming rate. According to the FDA, the approval of such drugs has decreased by 70 percent since the mid-1980s. This is unacceptable. The development of just one new antibiotic can take upwards of 10 years. We must act now to avoid a potential health care crisis.

When I am back in Kansas--and I know when other Senators are back in their States--talking to folks about health care, I often hear about the problem with drug shortages. When a problem exists in an urban setting, simply multiply that 10 times, and that is what we have in our rural areas. This is never more true than on the issue of drug shortages. This is a crisis. As difficult as it is to hear from my hospital administrators and pharmacists in Kansas about the difficulties they are having in getting drugs to fill prescriptions for patients, nothing compares to the patients and the families of patients who can't get their drugs, who can't get their treatment, who are already scared about their future and they can't get their lifesaving medication due to shortages. This is unacceptable. That is why I joined with a number of my colleagues on the HELP Committee to work together to see if we could come to a bipartisan consensus on a way to alleviate at least some of the burden drug shortages create. The legislation now requires reporting on drug shortages, but it also provides some transparency and accountability in the hope that we can get to the root cause of this problem.

Not everything in this legislation is what I would have done if I had my choice--that is obvious and probably the case with every Senator and every major bill on which we must make decisions. I am certain many of my colleagues on the HELP Committee are thinking the same thing. However, I think we are all pleased we were able to come to a bipartisan consensus on this legislation and in addressing many of the issues that are affecting Kansans and the rest of Americans.

I talked with a fellow last night who said: Why can't you all work together? Why can't you pass something in a bipartisan way?

This legislation is a good example of exactly what that gentleman was talking about and what a lot of Americans are concerned about. In that regard, I thank Chairman Harkin and Ranking Member Enzi for all of their work and for all of the work by their staff and our staff over the past years and months in putting together this important piece of legislation. This took a long time. It took a lot of effort. It took a lot of hard work. Their commitment to a bipartisan process and their willingness to communicate with all the members of the HELP Committee has led us through a relatively noncontentious markup, and I hope the same will happen as we consider this legislation on the floor.

I yield the floor.

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