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Senator Clinton Announces Key Senate Committee Approval of Bill to Reauthorize Pediatric Rule

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Location: Washington, DC


Senator Clinton Announces Key Senate Committee Approval of Bill to Reauthorize Pediatric Rule

Senator Hillary Rodham Clinton today announced that the Health, Education, Labor and Pensions (HELP) Committee has approved the Pediatric Research Improvement Act. The bill, which was introduced by Senator Clinton last month, would renew 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. The bill now awaits a full Senate vote.

"The pediatric rule has been one of the great success stories. It has held drug companies accountable for proving that new medicines for children are safe and effective for our kids. It has saved lives and reduced suffering for children and provided critical information for caregivers, ending what too often was a guessing game for pediatricians and parents. Reauthorizing the pediatric rule will allow us to continue these strides and make sure that children's health remains a top priority for the FDA," said Senator Clinton.

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 approved by the HELP Committee would extend the pediatric rule for the next five years. This legislation 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 reiterated her commitment to making the pediatric rule permanent and vowed to work with HELP Committee Chairman Kennedy to achieve this goal.

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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