HHS to enforce proper drug labeling for pediatric use

Department of Health and Human Services Secretary Tommy G. Thompson has 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.

This is a reversal of the FDA’s March announcement that it was suspending the "pediatric rule" for two years. The FDA wanted to determine whether the Best Pharmaceuticals for Children Act (BPCA), which President Bush signed into law in January 2002, made the rule necessary. BPCA provides new funding mechanisms for pediatric studies and other provisions that encourage the development of better information on the effective use of drugs in children.

The FDA does plan to update the pediatric rule, which was adopted in 1998. The FDA planned to issue an Advanced Notice of Proposed Rulemaking that will be published in the Federal Register. A copy of the notice is available at www.fda.gov/OHRMS/DOCKETS/98fr/oc02105.pdf

Thompson also said that the National Institutes of Health would 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.