November 2002

Federal Court Overturns FDA Pediatric Rule

Washington, D.C. – A federal district court has overturned the Food and Drug Administration’s Pediatric Rule. In a ruling issued this month, the court found the rule goes beyond the agency’s statutory power. The Competitive Enterprise Institute (CEI), the Association of American Physicians & Surgeons and Consumer Alert filed a suit against the rule in December 2000.

Under the Pediatric Rule, which the FDA issued in 1998, the agency could demand that drug manufacturers perform testing on “off-label” pediatric uses. Even though a drug may be labeled for use by adults only, companies could be required to test for use by children is there was a likelihood that pediatricians would use it.

“In our view, the Pediatric Rule constituted a drastic change in the drug approval process,” said Sam Kazman, CEI’s general counsel. “FDA essentially claimed it could force new uses or new patient populations – in this case children – on a label. While the rule was limited to pediatric uses, it opened the door for testing requirements for other off-label special patient populations and for other off-label uses. The end result could be a far riskier and costly approval process and, ultimately, fewer drugs.”

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