The Food and Drug Administration announced Nov. 27 final regulations to ensure that drug companies provide physicians with information on the safe and appropriate pediatric uses of new drugs. In treating illnesses such as pediatric AIDS, the lack of information has been particularly challenging. The regulations, however, will require pediatric labeling for drugs that will be therapeutically important or commonly used in children. Also, the rule would allow the FDA to require pediatric testing of already-marketed products in certain compelling circumstances, such as when a drug is commonly prescribed for children and the lack of pediatric dosing information could pose serious risks. In some instances, however, pediatric testing could be delayed until preliminary adult studies confirm the drug's safety and efficacy or when a comparable drug exists for pediatric use.
Pediatric studies are impossible or highly impractical.
Reasonable efforts to develop a pediatric formulation have failed.