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News Release

STATEMENT BY TOMMY G. THOMPSON
Secretary of Health and Human Services
and
MARK B. McCLELLAN, M.D., Ph. D.
Commissioner of Food and Drugs
Regarding Passage of S. 650, The Pediatric Research Equity Act of 2003

We commend the Senate for today's action in passing the Pediatric Research Equity Act of 2003. This legislation is another step toward closing the gaps that have existed in guaranteeing proper testing of pharmaceutical products for children. Under the President's leadership, HHS agencies have already taken important steps toward assuring the safety and efficacy of drugs when given to children. But an important action that is still needed is clear legislative authority for the Food and Drug Administration (FDA) to require pediatric testing for appropriate products. The Senate has taken us another step toward that goal.

Many of the innovative pharmaceutical products now being developed are likely to be used in children. But medicines to be used by children should undergo specific pediatric testing, and not simply rely on adult tests. This testing is needed both for new drugs and also for already-approved drugs that may be prescribed for children but still lack pediatric testing.

Congress took one important step toward addressing this need with enactment of the Best Pharmaceuticals for Children Act (BPCA) in January 2002. This legislation authorized HHS' National Institutes of Health and the FDA to undertake pediatric testing of already-approved drugs that do not benefit from other types of pediatric development incentives. We are carrying out this mandate. Earlier this year, HHS identified an initial list of 12 already-approved drugs that urgently need pediatric testing. We are making up to $25 million available this year to begin this process, and the President has proposed to double the amount to be available in the coming fiscal year.

At the same time, the BPCA also extended incentives for pharmaceutical companies to provide pediatric testing for new products, and this action has also helped ensure that appropriate testing takes place for many new drugs.

However, it remains important for FDA to have clear authority to require pharmaceutical manufacturers to conduct pediatric clinical trials on appropriate drugs and biologics. The Senate's action takes us a step closer toward enactment of a law to make that authority clear. We thank HELP Committee chairman Gregg and Ranking Member Kennedy for their leadership in shepherding this legislation, and we express the hope that the House of Representatives will also act soon on this important issue.

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Note: All HHS press releases, fact sheets and other press materials are available at http://www.hhs.gov/news.

Last Revised: July 24, 2003