Improving health care for children

FDA Consumer, March-April, 2004

The FDA can now require certain research that will improve the quality of health care for children. This authority was granted to the agency under a new law known as the Pediatric Research Equity Act. Signed by President Bush in December 2003, the law allows the FDA to require drug firms to conduct pediatric studies of drugs when needed to ensure that the drugs are safe and effective when used in children.

"The Pediatric Research Equity Act of 2003 will allow FDA to close the knowledge gap when it comes to treating children," says FDA Commissioner Mark B. McClellan, M.D., Ph.D. "FDA will now have clear authority to require pediatric studies of drugs when other approaches are not sufficient to ensure that drugs are safe and effective for children."

Prior to the act, studies of drug effects in children were done infrequently, and doctors had to rely on adult test results when prescribing drugs to children.

"Prescription drugs can do more than ever to cure diseases, including illnesses in children," says McClellan. "But it is not good medicine to assume that children can be treated like little adults. Parents and health professionals deserve confidence that medicines used to treat children are safe and effective. FDA will use this important new law to require pediatric studies, when necessary, to give parents and doctors the confidence they deserve."