Bill Clinton: “today I am introducing the Pediatric Research Improvement Act, legislation to reauthorize the Pediatric Rule and extend…”

“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.”