A US federal judge has overruled the Food and Drug Administration's requirement that drug companies test some of their products on children, saying the agency had overstepped its authority in requiring companies to do so.
The rule, promulgated by the FDA in 1998, has been generally accepted by the pharmaceutical industry, and the number of drugs tested for use by children has been rising. The rule has been considered a major success by the FDA and public health advocates in helping increase the number of drugs available for routine use in children.
The FDA said it was “very disappointed” by the decision. “We still think it is vitally important that drugs be studied in children so that their safety and efficacy can be determined on the basis of sound data,” said FDA spokesman Lawrence Bachorik. He said the agency is “weighing its options” on how to proceed.
Before the FDA rule was implemented, most drugs were approved after being tested only in adults. Doctors prescribing of drugs for children would be based on their own medical experience. Congress passed legislation in 1997 that encouraged drug companies to test their drugs on children.
But several groups, including the Competitive Enterprise Institute, a public policy group in Washington, DC, and the Association of American Physicians and Surgeons, sued the FDA to overturn the rule. They argued that it improperly expanded the agency's authority because it went beyond the original legislation by compelling companies to conduct tests on children and opened the door to greater regulation of off label uses of drugs, which are widespread in medicine.
In the court decision district judge Henry Kennedy Jr, of the federal court for the District of Columbia, agreed with their argument.