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Hearing of the Senate Committee on Health, Education, Labor and Pensions on Ensuring Safe Medicines and Medical Devices for Children


Location: Washington, DC

Senator Clinton's Opening Statement at Senate HELP Committee Hearing

Senator Dodd has such a long history of being on the forefront of all of the efforts we've made in the Congress over a number of years now on behalf of children and families, and it's a real pleasure to be here with both he and Senator Alexander. I'm pleased to be Senator Dodd's co-sponsor on the Pediatric Medical Devices Safety and Improvement Act, when that is finally offered, because it will improve the number and types of medical devices designed for pediatric populations.

And I particularly want to thank the witnesses today, who are going to give us the guidance that Senator Alexander said that we need to have. And I welcome back Susan Belfiore and her family because she's been an advocate on behalf of these issues along with her family for a number of years now.

The type of drugs and the number of drugs that are available for children has been an issue for me for many years. Back during the Clinton Administration, I first worked with the Food and Drug Administration and the Elizabeth Glaser Pediatric AIDS Foundation and other patient groups to establish the Pediatric Rule which requires that drug manufactures ensure medications marketed for pediatric use are safe and effective for our children. And then when this regulation was challenged in court, I worked with my colleagues in the Senate, Senator Dodd and Senator DeWine to get the Pediatric Rule enacted into law. And this landmark law, the Pediatric Research Equity Act was a real step forward. We can look at the changes and realize how much has occurred and yet still know we still have a long way to go.

As of the early 1990s, only about 20 percent of drugs contained specific pediatric dosing information, but we know that children are not just little adults, and a drug that reacts one way in an adult's body can have serious consequences in a child. And as Senator Alexander said, we sometimes tragically discover this.

We've put pediatricians in the past into a guessing game, trying to determine if a drug appropriate for an adult would have the same pharmacological effects on a child. But thanks to combined efforts the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act, we're now able to use the best evidence to make better healthcare decisions for children. We're now requiring submission of pediatric clinical trial data for new drug applications so that we can be better assured that drugs marketed for children are safe and effective.

Indeed, more than a thousand new and supplemental drug applications have fallen under the scope of the Pediatric Rule and the Pediatric Research Equity Act. The Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act have managed to increase our understanding of the way drugs work in a pediatric population.

For example, we've learned that a drug commonly prescribed for migraines in adults is not effective in pediatric populations and may actually cause serious adverse consequences. We've learned that methylphenidate, a drug prescribed for attention-deficit hyperactivity disorder, is processed more by adolescents than other age groups, therefore requires different dosages.

We've been able to collect data on drugs commonly used in children - like azithromycin, an antibiotic used to treat bronchitis, pneumonia, and respiratory infections- as well as drugs that are not so commonly used, but that help keep children alive, like emtriva one of the newer drugs we have to treat AIDS.

But, both of these Acts are scheduled to expire in September if they're not reauthorized. So, that's why this hearing is so timely and important.

And I'll be introducing the Pediatric Research Improvement Act legislation that would reauthorize the Pediatric Research Equity Act and make permanent the FDA's authority to require submission of pediatric clinical trial data for drugs designed for children.

I just want to emphasize this one point. When both of these bills were passed they had what are called sunsets, which means that you have to go back and reauthorize them. I think that there is general agreement that the Best Pharmaceuticals Act probably is one that a sunset is important for to make sure that the incentives that Senator Dodd designed are working the way they should. But, it seems a little strange that we would have to reauthorize the Pediatric Rule. We don't have sunsets on getting adult clinical data to determine what happens with drugs in adults. We shouldn't have any kind of sunset on getting the same data for children.

I think we should make this Pediatric Rule permanent and I will be introducing legislation to do that. It will also approve the ability of the FDA to require testing on already marketed drugs when drug companies refuse to carry out that testing on their own and better coordinate the incentives in these important laws. So, I'm very pleased to be here and continue to work with my colleagues led by Senator Dodd to get this done.

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