Washington, DC - Today, Senator Hillary Rodham Clinton introduced the Pediatric Research Improvement Act, legislation that would make permanent the Food and Drug Administration's authority to ensure that drugs marketed for pediatric use are safe and effective for children. Without action by September 30, the FDA's authority to require drug companies to submit pediatric data will expire.

"By making the Pediatric Rule permanent, we can continue to hold drug companies accountable for proving that new medicines for children are safe and effective for our kids. We can also keep giving families and healthcare providers information they need to make the best healthcare decisions for our children. Children's health is too important to ever again be a guessing game."

During the Clinton Administration, Senator Clinton worked with the FDA and patient groups to establish the Pediatric Rule, which requires drug manufacturers to ensure medicines marketed for pediatric use are safe and effective for kids. 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, Senator Clinton worked with her 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 2004, approximately 150 approved new drugs have completed pediatric studies as required under this law.

The Pediatric Research Equity Act is set to expire on September 30 of this year, and the bill Senator Clinton introduced today would permanently extend the Pediatric Rule. In addition to removing the sunset provisions, it would increase the amount of data available about the use of the Pediatric Rule, expand the role of pediatric specialists in reviewing labels and other pediatric data, and require evaluations of the ways in which the pediatric rule contributes to improved access to therapies for children.

Senator Clinton's bill is supported by the American Academy of Pediatrics, Ambulatory Pediatric Association, American Pediatric Society, Association of Medical School Pediatric Department Chairs, the Society for Pediatric Research, and the Elizabeth Glaser Pediatric AIDS Foundation.

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Senator Clinton's Opening Statement at Senate HELP Committee Hearing on Ensuring Safe Medicines and Medical Devices for Children

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