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Federal Court Invalidates FDA’s ‘Pediatric Rule’ on Drug Safety Tests

Federal Court Invalidates FDA’s ‘Pediatric Rule’ on Drug Safety Tests

A federal court has invalidated the US Food and Drug Administration'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. The plaintiffs' attorneys argued that FDA exceeded its powers in the Pediatric Rule. "FDA has no authority to require manufacturers to conduct studies of drug uses for which they do not intend to seek approval or devise formulations of the drug tailored to those uses," they said in a motion to overturn the rule.

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