Statements on Introduced Bills and Joint Resolutions

Floor Speech

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By Mr. REED (for himself, Mr. Alexander, Mrs. Murray, and Mr. Roberts):

S. 2289. A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions; to the Committee on Health, Education, Labor, and Pensions.

Mr. REED. I am pleased to be joined today by Senators ALEXANDER, MURRAY, and ROBERTS in introducing the Better Pharmaceuticals and Devices for Children Act, BPDCA. This legislation will ensure that children are prioritized in the drug development process, as well as continue the increase in the number and quality of medical devices developed for use in children. I am particularly pleased that this bill has the support of the American Academy of Pediatrics and the Pharmaceutical Research and Manufacturers of America.

Indeed, drugs and devices work differently in children than in adults, and consequently, must be studied specifically for use in children. However, due to the fact that pediatric trials can be costly, take several years, and offer less of a return on investment, drug companies weren't initiating these trials. As a result, nearly 80 percent of drugs were used off-label in children.

This alarming statistic garnered the attention of pediatricians, medical experts, families, and ultimately, Congress. In 1997, Congress provided pharmaceutical companies with an incentive to invest in pediatric research through the Best Pharmaceuticals for Children Act, BPCA. In 2003, Congress passed the Pediatric Research Equity Act to begin requiring pharmaceutical companies to engage in these studies. Since the enactment of these laws, 426 drug labels have been revised with important pediatric information and there has been a decline in the number of drugs used off-label in children from 80 to 50 percent.

However, these laws will expire on October 1 unless Congress passes legislation to renew them. The Better Pharmaceuticals and Devices for Children Act would ensure that these laws are never at risk of expiring again. Laws that examine the safety and effectiveness of drugs and devices in adults are permanent. Children should have the same assurances. By making these laws permanent, pharmaceutical companies will also gain the certainty they need to continue wisely investing in these studies.

In making these laws permanent, we must not miss an opportunity to improve their benefits for children to ensure that more robust and timely information about the use of drugs and devices can guide clinical care. This legislation does just that.

First, it would ensure pediatric studies are planned earlier in the drug development process. Currently, pediatric study plans can be submitted to the FDA when a company submits its new drug application. This can be a very stressful time for a company and, as such, pediatric study plans are often left to the last minute. This has traditionally resulted in insufficient and inappropriate study plans, as well as delays of important pediatric data. Our legislation would require companies to submit a more robust pediatric study plan at the end of phase two in the drug development process. By this time in the process, a company already has performed the requisite clinical trial or trials in adults and has a better understanding of a drug's safety and efficacy, as well as dosing requirements. Moreover, experts at the FDA initially tried to require companies to submit a pediatric study plan at this time in the drug development process in a regulation that was struck down by the courts. However, the rationale and justification behind the regulation helped inform the drafting of this legislation and led us to believe that companies should submit their initial pediatric study plan to the FDA at the end of phase two.

The legislation would also ensure that pediatric studies are actually completed. An alarming 78 percent of pediatric studies that were scheduled to be completed by September 2007 are currently late or were submitted late. While it is appropriate for some studies to take longer than expected and we wouldn't want a pediatric study to hold up the approval of a drug for use in adults it is unacceptable for companies to fail to complete pediatric studies altogether. Our bill would give the FDA the authority to distinguish between reasonable and unreasonable delays in pediatric studies and provide the agency with critical enforcement tools to ensure required pediatric studies are completed. This legislation would also provide the FDA with the ability to better track the progress of studies and assist with any complications.

The Better Pharmaceuticals and Devices for Children Act also responds to the need for the development of pediatric medical devices in children, which can lag five to ten years behind those manufactured for adults. The pediatric profit allowance for Humanitarian Use Devices has proven to be an effective incentive for the development of new medical devices that are designed specifically for the needs of children. Our bill would continue this important policy. It would also reauthorize the Pediatric Device Consortia, which in just two and a half years, has assisted in advancing the development of 135 proposed pediatric medical devices and helped get life-saving and life-improving pediatric devices to the patients that need them.

This legislation is critical for children's health. It will help give parents peace of mind that when their doctor prescribes a medication or recommends a medical device for their kids, it is proven safe and effective for specific use in children.

It is my understanding that Chairman Harkin will be including this legislation as part of a broader initiative that the Health, Education, Labor, and Pensions Committee will soon be considering focused on improving drugs and devices. I look forward to working with Senators ALEXANDER, MURRAY, and ROBERTS, as well as the Chairman and others on moving this bill forward before the October deadline.

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