Nancy Kassebaum: “today, together with Senators Dodd, Hatch, and Simon, I am introducing the Better Pharmaceuticals for Children Act. This…”

“today, together with Senators Dodd, Hatch, and Simon, I am introducing the Better Pharmaceuticals for Children Act. This legislation provides a strong incentive for pharmaceutical companies to conduct pediatric trials for drugs which are developed primarily for adults. It establishes a 6-month market exclusivity for pharmaceuticals for which pediatric studies are conducted at the request of the Secretary of Health and Human Services. This incentive to conduct pediatric studies is sorely needed. Currently, fewer than 30 percent of the prescription medications on the U.S. market are approved for use by pediatric populations and labeled for pediatric use. Pediatricians using drugs developed with adults in mind but which may also be effective in children or be the only option for treating the same diseases or illnesses in children must estimate dosages from dosages found safe and effective in adults. Such estimates are uncertain because children, and particularly those under 2 years of age, often metabolize drugs differently than do adults. Further, some drugs can be less safe in children than in adults even when appropriate doses are used. For these reasons, pediatricians have long had an active interest in promoting clinical trials of drugs in infants and children so that the drugs can be labeled for use by these age groups.”