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…
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.