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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

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

"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

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


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