[Congressional Record Volume 153, Number 53 (Tuesday, March 27, 2007)]
[Senate]
[Page S3842]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mrs. CLINTON (for herself and Mr. Dodd):
  S. 993. A bill to improve pediatric research; to the Committee on 
Health, Education, Labor, and Pensions.
  Mrs. CLINTON. Mr. President, today I am introducing the Pediatric 
Research Improvement Act, legislation to reauthorize the Pediatric Rule 
and extend it permanently. I believe that doing so is critically 
important to ensure that the drugs designed for children are safe and 
effective for children. This legislation will result in better health 
outcomes for our children, grandchildren, and many generations of 
children to come.
  In 1998, the FDA issued a regulation called the pediatric rule, which 
allowed the agency to require companies to perform pediatric clinical 
trials on medications used by children. It is important to note that 
this requirement does not slow the drug approval process. If a drug is 
not likely to be used in the pediatric population, it is not subject to 
this testing. Companies can also apply for a deferral, so that they can 
perform necessary tests after a drug has been approved and is being 
used in the adult population.
  In October 2002, a U.S. District Court found that the FDA had 
exceeded its statutory authority when it promulgated the Pediatric 
Rule, and that Congress needed to explicitly award the FDA the power to 
require these clinical trials.
  In response, I worked with my colleagues in Congress to pass the 
Pediatric Research Equity Act, legislation that codified the Pediatric 
Rule, and which was signed into law on December 3, 2003.
  Since 2003, over 100 drugs have been evaluated under PREA--and since 
1998, more than 1,000 drugs have fallen under the authority of the 
pediatric rule. The legislation has successfully resulted in increased 
pediatric evaluations. We've been able to collect data on drugs 
commonly used in children--like azithromycin, an antibiotic used to 
treat bronchitis, pneumonia, and other respiratory infections--as well 
as drugs that may not be so commonly used, but that help keep children 
alive, like emtriva, one of the newer drugs we have to treat AIDS.
  But unless we act to reauthorize this legislation now, the pediatric 
rule is set to sunset on September 30 of this year, placing in jeopardy 
the ability of the agency to require these safeguards for our children.
  In order to address this, I am introducing the Pediatric Research 
Improvement Act to remove the sunset for the pediatric rule, so that we 
will never again be in danger of losing the authority to make sure that 
the drugs designed for children are safe for children.
  In addition to making the rule permanent, this reauthorization would 
do the following:
  Improves Coordination between Pediatric Specialists and Others at the 
FDA. In order to improve coordination with the pediatric exclusivity 
provisions of the Best Pharmaceuticals for Children Act (BPCA), PRIA 
would expand an internal FDA committee to review all issues of 
pediatric-related labeling and assessments. Doing so ensures that a 
drug that falls under PRIA or BPCA is reviewed not only by experts for 
that particular drug, but those with pediatric expertise.
  Streamlines the process for obtaining pediatric data on already-
marketed drugs. If a company chooses not to pursue pediatric 
exclusivity for an already marketed drug under the Best Pharmaceuticals 
for Children Act, the Secretary has the authority to require the 
submission of pediatric data for the drug. This authority has never 
been utilized, in part due to the lengthy administrative process 
required. PRIA would streamline this administrative process and help 
get essential data on drugs for which it is vitally needed, while 
preserving the ability of companies to have a fair review of the 
agency's decisions.
  Increases Data about the Use and Applicability of PRIA. PRIA would 
require two reports--one from the Institute of Medicine and one from 
the GAO--that would allow us to have better data on the number and ways 
in which the pediatric rule is used, and evaluate its contributions to 
ensuring overall pediatric drug safety.
  This legislation is supported by the American Academy of Pediatrics, 
Elizabeth Glaser Pediatric AIDS Foundation, Ambulatory Pediatric 
Association, American Pediatric Society, Association of Medical School 
Pediatric Department Chairs, and the Society for Pediatric Research.
  I look forward to working with my colleagues in Congress to pass this 
vital piece of legislation as quickly as possible, and help to ensure 
that our pediatricians and other health professionals have the tools 
they need to provide safe and effective treatment to our Nation's 
children.
                                 ______