HHS NEWS

P98-37                        FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE         Print Media:         301-827-6242
November 27, 1998             
                              Consumer Inquiries:  888-INFO-FDA

FDA ACTS TO MAKE DRUGS SAFER FOR CHILDREN

Today's announcement marks an important milestone in the administration's effort to make drugs safer and more effective for children.

"Our children are the nation's most precious resource and we must do everything possible to ensure they get the best medical treatment," said President Clinton. "Today's action represents our continuing commitment toward this goal."

Every year more than half of newly approved drugs and biologics that are likely to be used in children lack information to permit safe and effective use. Without adequate information, physicians may be reluctant to prescribe certain drugs for their pediatric patients, or they may prescribe them inappropriately. The new rule makes it more likely that children will receive improved treatment because doctors will have more complete information on how drugs affect children and what age- appropriate doses are needed.

"Pediatricians and other health care providers will now have more specific dosing information based on scientific evidence," said First Lady Hillary Rodham Clinton. "This will make prescribing medication for children safer and may also lessen the number of side effects."

The rule also allows FDA to require pediatric testing of already-marketed products in certain compelling circumstances such as when a drug is commonly prescribed for use in children, but the absence of adequate labeling could pose significant risks.

FDA issued a regulation in 1994 simplifying the type of information needed to demonstrate the safety and effectiveness of drugs in children to encourage drug manufacturers to submit pediatric data voluntarily for review. While these voluntary efforts were helpful, there are still a large number of drugs and products without adequate pediatric labeling.

"We are committed to ensuring that health care providers get the best information they need to treat children," said Michael A. Friedman, M.D., Acting FDA Commissioner. "By simplifying the information requirements, providing financial incentives in the FDA Modernization Act and enacting these new regulations, we have taken great strides forward."

The final rule allows pediatric data to be submitted after a drug has already been approved if FDA has safety concerns about testing the drug on children prior to testing it on adults. FDA, however, will not delay the approval of a drug for adults if the pediatric studies are not yet completed.

Even if the drug is one that is commonly used in children or will be therapeutically important for children, the pediatric study requirement can be waived entirely if:

• FDA finds that the product is likely to be unsafe or ineffective in pediatric patients,
• pediatric studies are impossible or highly impractical, or
• reasonable efforts to develop a pediatric formulation have failed.