Washington, D.C., October 18, 2002—A federal district court has overturned the Food and Drug Administration’s Pediatric Rule. In a ruling issued late yesterday, the court found the rule goes beyond the agency’s statutory power. The Competitive Enterprise Institute, the Association of American Physicians & Surgeons, and Consumer Alert had filed suit against the rule in December 2000.
Under the Pediatric Rule, which FDA issued in 1998, the agency can demand that drug manufacturers perform testing on “off-label” pediatric uses. Even though a drug may be labeled for use by adults only, it would have to be tested on children if there was a likelihood pediatricians would use it. The agency claimed it was acting to protect children, but CEI and the other plaintiffs argued the result would be a more burdensome approval process with fewer new drugs overall.
“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.”
In yesterday’s ruling, the judge reached the merits of the issue. It found that FDA's approach was unauthorized under the Food, Drug and Cosmetic Act, and was contrary to the voluntary, incentive-based approach that Congress has taken to encourage off-label pediatric testing.
The Washington, D.C. law firm of Wiley, Rein, & Fielding represented the plaintiffs pro bono. AAPS is a non-profit organization of physicians dedicated to preserving the practice of private medicine. CEI and Consumer Alert are non-profit public interest groups involved in opposing government overregulation. The court’s decision is available online.
CEI General Counsel Available for Interviews on Pediatric Rule Decision Sam Kazman General Counsel 202.331.1010, ext. 218
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CEI is a non-profit, non-partisan public policy group dedicated to the principles of free enterprise and limited government. For more information about CEI, please visit our website at www.cei.org.
