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Date: Wednesday, August 13, 1997 FACT SHEET Contact: Ivey Kupec (301) 443-3285
Today, President Clinton unveiled a new FDA regulation that will protect children by requiring drug manufacturers to study the safety and appropriate dosage levels of medications for pediatric populations. The regulation also requires proper labeling of drugs for use by children. Even though many drugs affect children differently than adults, most drugs have not been tested on pediatric populations. Under this rule, manufacturers of prescription drugs likely to be used by children will be required to complete studies and place information on drug labels to help pediatricians and other health care providers make scientifically-based treatment decisions when prescribing drugs to children.
WHY THIS REGULATION IS NEEDED
Most drugs -- even those commonly used in children -- have not been widely tested on pediatric populations. According to the American Academy of Pediatrics, only a small fraction of drugs and biological products marketed in the United States have had clinical trials performed on pediatric patients. Despite evidence that drugs affect children differently than adults, 80 percent of all drugs marketed in the United States have not been labeled for use by infants, children, and adolescents. Only forty-two percent of drugs that are widely used in pediatric populations have been tested on children.
Drugs are likely to have a different impact on children than adults. The appropriate use and dosage levels of medication for children and adults is usually different because of disparities in organs, the immune system, and metabolism.
Children who take prescription drugs that have not been tested on pediatric populations are at serious risk for unexpected adverse reactions. Evidence suggests that prescribing drugs that have not been adequately tested on children can be extremely dangerous. One example of the possible harm is the case of "gray baby syndrome" where a number of babies died from chloramphenicol, an antibiotic that their immature livers were unable to accept. Other children had withdrawl symptoms from prolonged administration of fentanyl, a pain killer used as an adjunct to anesthesia in infants and small children. Still others have suffered seizures and cardiac arrest from bupivacaine, a local anesthetic not adequately tested on pediatric populations.
Some physicians are reluctant to prescribe much needed therapies to children because they have not been tested on pediatric populations. Physicians report that they have denied children important new drugs because, in the absence of adequate testing and labeling, they would have to guess at an appropriate dosage, and they do not want to take that risk. As a result, too many children do not receive the treatment they need and deserve.
SUMMARY OF THE RULE
Pediatric Studies for New Drugs. Under this proposed rule, manufacturers of new drugs would have to do studies on pediatric populations under two circumstances: when the product represents a meaningful therapeutic benefit over existing treatments; or when the product is expected to be widely used on pediatric patients. The FDA anticipates that about twelve new products each year would meet this requirement. Manufacturers could receive waivers from the requirement to do a pediatric study under any one of the following circumstances:
Pediatric Studies for Existing Drugs. For drugs that are already on the market, the new FDA regulation requires additional testing on the pediatric population only if there is a "compelling need for more information." The criteria used is: