WASHINGTON—A federal court has invalidated the FDA’s "Pediatric Rule" after concluding that its requirement that drug companies test the safety of adult drugs in children is contrary to the intent of Congress.
Judge Henry H. Kennedy, Jr., of the US District Court for the District of Columbia, enjoined the FDA from enforcing the regulation. He found that the rule exceeded the wording of laws passed by Congress that provide specific incentives to the pharmaceutical industry to establish the safety of new and approved drugs in pediatric patients. The FDA can appeal Judge Kennedy’s ruling to the Circuit Court of Appeals.
The agency proposed the Pediatric Rule in 1997, stating that it did not believe "that incentives alone will result in pediatric studies of some of the drugs and biologics where the need is greatest." Oncologic drugs were one area of particular concern.
The rule became effective on April 1, 1999, and required companies filing new drug applications to provide "data adequate to assess whether the drug is safe and effective in pediatric populations." Pediatric testing could be deferred until after the FDA approved the adult usage of the drug. The rule also gave the agency the power to require companies to provide evidence to support the dosage and administration of approved drugs in some or all of the pediatric subpopulations, including neonates, infants, children, and adolescents.
"The Pediatric Rule may well be a better policy tool than the one enacted by Congress; it might reflect the most thoughtful, reasoned, balanced solution to a vexing public health problem," Judge Kennedy said in his decision. "The issue here is not the rule’s wisdom. . . . The issue is the rule’s statutory authority, and it is this that the court finds lacking."
The rule was challenged by three groups—the Association of American Physicians and Surgeons and two advocacy groups that oppose excessive government regulations, the Competitive Enterprise Institute and Consumer Alert.
In his decision, Judge Kennedy acknowledged that the Pediatric Rule sought to address a significant public health issue. He noted that because of expense and the difficulty of recruiting significant numbers of pediatric patients in clinical trials, many drugs are tested in adults only. As a result, he said, "physicians with pediatric patients often find their treatment options limited." Often the decision is made to prescribe a drug off-label at a reduced dosage, which "can expose children to various hazards."
