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FOR IMMEDIATE RELEASE |
Media Inquiries: 301-827-6242 |
President Bush today signed important new legislation that will enable the Food and Drug Administration to improve the quality of health care for our children.
FDA has worked diligently to use its available authorities and resources to give pediatricians and parents the solid information they need to treat children who are ill. These programs, which include financial incentives and new funding to conduct needed pediatric studies, have helped develop needed evidence on the effects of medicines in children. But in some cases needed studies have not been done. FDA's most recent attempt to require pediatric studies failed when the U.S. District Court for the District of Columbia held in October 2002, that our agency lacked sufficient statutory authority.
When it goes into effect today, the Pediatric Research Equity Act of 2003 will allow FDA to close the knowledge gap when it comes to treating children. FDA will now have clear authority to require pediatric studies of drugs when other approaches are not sufficient to ensure that drugs are safe and effective for children.
I wish to once again thank the President, Senate HELP Committee Chairman Gregg, Ranking Member Kennedy, Senator Dewine, House Energy and Commerce Committee Chairman Tauzin and Ranking Member Dingell, Representatives Greenwood, Bilirakis and Eshoo, as well as other original co-sponsors of the legislation, for giving our agency this necessary authority. I also want to thank the American Academy of Pediatrics and the Elizabeth Glaser Pediatric AIDS Foundation for their support. Today's signing lends the anniversary of Elizabeth's untimely death a special meaning, by providing new hope for children.
Prescription drugs can do more than ever to cure diseases, including illnesses in children. But it is not good medicine to assume that children can be treated like little adults. Parents and health professionals deserve confidence that medicines used to treat children are safe and effective. FDA will use this important new law to require pediatric studies, when necessary, to give parents and doctors the confidence they deserve.
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