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Public Statements

Food and Drug Administration Reform Act of 2012

Floor Speech

Location: Washington, DC

Ms. ESHOO. Mr. Speaker, I rise today to speak in support of H.R. 5651, the Food and Drug Administration Reform Act of 2012, to reauthorize the Prescription Drug User Fee Act and the Medical Device User Fee Act. These critically important laws have improved patient access to important therapies and expedited the FDA's approval times while upholding the most rigorous standards for patient safety.

The Prescription Drug User Fee Act, PDUFA, was enacted in 1992 when drug review times were lagging and FDA simply couldn't keep up with the flood of new drug applications. Through user fees paid by applicants, PDUFA gave FDA the resources it needed to hire and support more staff. The program has been successful at reducing review-time backlogs and expediting safe and effective therapies to patients.

Along with faster drug approvals, Congress also recognized the need to study drugs in children. As the original author of the Best Pharmaceuticals for Children Act, BPCA, and the Pediatric Research Equity Act, PREA, I'm proud of how successful these programs have been in treating children, resulting in new dosing information, new indications of use, new safety information, and new data on effectiveness. Before BPCA and PREA, the vast majority of drugs (more than 80 percent) used in children were used off-label, without data for their safety and efficacy. Today, that number has been reduced to 50 percent.

We know that children are not just small adults--they have unique medical needs and drugs react differently in their bodies. That's why in this year's reauthorization, it was important for us to look at areas in need of improvement.
The bipartisan legislation gives FDA the tools it needs to ensure companies are thinking about pediatric populations as early as possible in the drug development process, and that they're able to enforce timelines that are routinely missed. The language encourages further study into untested age groups, like neonates, and clarifies any confusion over what some see as ``loopholes'' to allow companies to access the market exclusivity incentive without completing additional studies.

The legislation ensures that companies routinely submit their pediatric plans earlier in the process by establishing a clear timeline and expectations. I will be closely monitoring the regulation that will implement the pediatric plan content, as it was my intention that the regulation closely mirror the 1998 Pediatric Rule.

I thank my colleagues, Rep. Mike Rogers and Rep. Edward Markey who worked tirelessly with me to improve these programs, and the American Academy of Pediatrics, along with 20 other pediatric advocacy groups who provided expert guidance and recommendations throughout the process. Together we've improved BPCA and PREA to benefit medical care for children for generations to come.

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