[Congressional Record Volume 158, Number 81 (Friday, June 1, 2012)]
[Extensions of Remarks]
[Page E948]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




            FOOD AND DRUG ADMINISTRATION REFORM ACT OF 2012

                                 ______
                                 

                               speech of

                           HON. ANNA G. ESHOO

                             of california

                    in the house of representatives

                        Wednesday, May 30, 2012

  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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