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News Release

HHS STATEMENT
On Approval of S. 650, the Pediatric Research Equity Act of 2003

HHS Secretary Tommy G. Thompson and FDA Commissioner Mark B. McClellan, M.D., today applauded Chairman Gregg, Ranking Member Kennedy, and the other members of the Senate Committee on Health, Education, Labor and Pensions for the committee's consideration and approval of S. 650.

"Yesterday's action is a major step in the right direction toward providing enhanced protection for America's children," Secretary Thompson said. "To protect our children and improve their health, the time to move forward on this important issue is now."

"Many of the innovative pharmaceutical products now being developed are likely to be used in children," said Dr. McClellan. "Medicines that children take should be tested in children. If enacted, S. 650 will help ensure that we meet this crucial public health goal. In the meantime, we do not have a full set of tools to get the pediatric testing that we need."

The Pediatric Research Equity Act of 2003 will provide the Food and Drug Administration (FDA) with additional authority to require pediatric studies of pharmaceutical products when they are needed to ensure their safe and effective use in children. On Oct. 17, 2002, the U.S. District Court for the District of Columbia held that FDA lacked sufficient statutory authority to require pediatric studies and prevented FDA from enforcing the requirements that were originally mandated in a 1998 final regulation known as the "pediatric rule"

On Dec. 16, 2002, the Bush Administration decided not to appeal the ruling and instead called on Congress to work with the Administration to swiftly enact the needed legislation to provide FDA with the authority to require pediatric studies. At that time, Secretary Thompson said, "The fastest and most decisive route for establishing clear authority in this area is to work with Congress for new legislation." "Children are a special population that need to have access to drugs that can benefit them, and these drugs need to be properly tested for pediatric use," said Dr. McClellan. "We have strongly defended the pediatric rule in court because public health will be best served by enabling FDA to require testing of drugs for pediatric use, but continued litigation is likely to take years, and its outcome is uncertain. The better course now is to work with Congress and enact new, specific legislation rapidly."

Last December, the Administration outlined key principles for pediatric legislation, including clear FDA authority to enable early consultation between manufacturers and the FDA in the drug development process regarding pediatric plans; authority to require pediatric data to be provided by manufacturer at the time of new drug approval application, or a timeline for pediatric data submission, if deferral is deemed appropriate; authority to require pediatric studies of already marketed products; and the creation of a new FDA Pediatric Advisory Committee.

HHS is pleased that the legislation reported by the Senate HELP Committee addresses the principles outlined in December and thank the committee for working with the Administration to develop and swiftly consider this legislation. The department looks forward to continuing to work with members in the Senate and House of Representatives to secure enactment of legislation to require pharmaceutical manufacturers to conduct appropriate pediatric clinical trials.

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Last Revised: March 25, 2003