[Congressional Record Volume 158, Number 55 (Tuesday, April 17, 2012)]
[Senate]
[Page S2395]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      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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