2002.04.19:HHS Launches New Pediatric Drug Safety Initiative

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FOR IMMEDIATE RELEASE
Friday, April 19, 2002

Contact:

FDA Press Office
(301) 827-6250

HHS LAUNCHES NEW PEDIATRIC DRUG SAFETY INITIATIVE

HHS Secretary Tommy G. Thompson today launched a new initiative to further ensure the safety and effectiveness of drugs used to treat children and promised to continue to enforce the Food and Drug Administration (FDA) rule requiring companies to take steps to ensure drugs are properly labeled for pediatric use based on scientific studies.

"Children need access to the same kinds of safe, effective treatments that are available to their parents, and that means conducting appropriate clinical trials," Secretary Thompson said. "We will enforce and improve the FDA's pediatric rule as we simultaneously take additional steps made possible when President Bush signed new legislation to promote the development of drugs that can save children's lives."

Key elements of HHS' pediatric drug initiative include:

FDA will continue to enforce the pediatric rule as it has since the rule took effect in 1999. The rule is an important tool in assuring that children receive safe and effective medical care. FDA will continue to defend the legal authority of the pediatric rule in court and will not pursue a stay of litigation.
� FDA will seek public comment on what additional steps it can take to assure adequate study of drugs in children in light of the Best Pharmaceuticals for Children Act (BPCA), which President Bush signed into law in January 2002. The law's provisions include new funding mechanisms for pediatric studies that companies choose not to conduct and other provisions that encourage the development of better information on the effective use of drugs in children. To get maximum benefit from these new authorities, the "pediatric rule" needs to be updated. The FDA will issue an Advanced Notice of Proposed Rulemaking that will be published shortly in the Federal Register. A copy of the notice is available at www.fda.gov/OHRMS/DOCKETS/98fr/oc02105.pdf.
HHS' National Institutes of Health (NIH) will request proposals this year using new contracting approaches authorized by BPCA to study certain drugs for pediatric use when manufacturers choose not to do so. NIH expects to award initial contracts under BPCA in fiscal year 2003. The new law also permits the NIH Foundation to fund pediatric studies of certain drugs with private donations received for that purpose, providing an additional funding source.
NIH also will provide $7 million in fiscal year 2002 funds to support pediatric drug research at its affiliated Pediatric Pharmacology Research Units. These funds will allow these units to study additional pediatric drugs.

"Through today's actions, we hope to use all the tools Congress has given us to ensure that drugs used in the treatment of children are indeed safe and effective," FDA Deputy Commissioner Dr. Lester Crawford said. "In addition, we want to ensure that adequate, good scientific information on the use of these products in children is made known to practitioners and parents so that they can make truly informed decisions regarding the use of these products."

"NIH will continue to work with the FDA and the pediatric community to get the BPCA program successfully initiated," said
Dr. Duane Alexander, director of NIH's National Institute of Child Health and Human Development. "The sooner we get this program underway, the sooner America's children can benefit from it."

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