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THE BETTER PHARMACEUTICALS FOR CHILDREN ACT< /h3>

Mrs. KASSEBAUM. Mr. President, today I am introducing the Better Pharmaceuticals for Children Act. This bill will create a new partnership among pharmaceutical researchers and manufacturers, pediatric researchers, and the government to improve the information about pediatric uses of pharmaceuticals. The provisions of this bill were originally included in S. 1477, the Food and Drug Administration [FDA] Performance and Accountability Act, which was approved in March, with bipartisan support, by the Senate Committee on Labor and Human Resources.

The Food, Drug, and Cosmetic Act requires a showing of safety and effectiveness before drugs can be marketed to the American public. Until recently, it was thought that such a showing would be the same for adults and children. It is now clear, however, that children are not small adults. They do not necessarily react to drugs the same way. New data are necessary to ensure that America's children have the same benefit of safe and effective drugs as our adults do. As it stands now, however, 80 percent of the drugs taken by children are not labelled for pediatric use.

The Better Pharmaceuticals for Children Act addresses this need for pediatric use data by providing an incentive to manufacturers to conduct pediatric studies for new and approved drugs. Manufacturers who provide pediatric data for the drugs most urgently needed by our children would receive an extra six months market exclusivity for their product. By taking this type of partnership approach, we can get critically needed information on pediatric uses. Providing the FDA with the extra authority to offer this type of encouragement will help to ensure that companies conduct such studies.

Under the bill, the Secretary of Health and Human Services is required to develop, in consultation with pediatric experts, a list of approved drugs for which additional pediatric information may produce health benefits in the pediatric population. For pediatric studies of new and approved drugs to trigger the six-month exclusivity incentive, they must be formally requested by the Secretary, and filed with the Secretary in an acceptable manner. Manufacturers would be precluded from obtaining more than one six-month period of exclusivity.

I am proud to join with Senators Kennedy, Dodd, DeWine, Mikulski, and Simon in introducing this bill. Mr. President, it creates a win-win situation in which manufacturers get a benefit for proactively testing drugs for pediatric use, while our children get timely access to the safe and effective drugs they so desperately need.

Mr. DODD. Mr. President, I rise today as a proud cosponsor, again, of the Better Pharmaceuticals for Children Act. I have cosponsored this legislation in several Congresses now, and hope that finally, we will pass this enormously important legislation.

This act would address a problem that pediatricians first recognized more than 30 years ago: information about safe and effective therapies for their young patients is scarce. According to the American Academy of Pediatrics only about one-fifth of all drugs marketed in the United States today, and only four of the 25 new drugs approved by the FDA last year, have been labeled for use by children.

Given this largely adults-only drug market, individual doctors face an uncomfortable dilemma with many of their child patients. Should doctors limit themselves to the handful of proven pediatric drugs? Some might not even exist for certain illnesses, and in such cases this could mean not treating a sick child. Or should they take a gamble on an adult drug and rely on their training, professional judgment, and luck to make it work as intended?

Most physicians find the latter option, known as `off-label prescribing,' to be the more acceptable choice. As a result, the American Academy of Pediatrics says that off-label prescribing has `by default become an established standard of care of children. '

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