Court Rules Against FDA Bid to Stop Pediatric Rule Challenge

Court Rules Against FDA Bid to Stop Pediatric Rule Challenge

October 28, 2001

Washington, D.C., October 29, 2001—A U.S. District Court judge has thrown out FDA’s motion to dismiss a lawsuit challenging the agency’s “Pediatric Rule.”  In his ruling late last week, U.S. District Court Judge Henry H. Kennedy, Jr. held that the three organizations filing the suit, the American Association of Physicians and Surgeons, CEI, and Consumer Alert, had alleged clear injuries that could result from the FDA rule, under which the agency can require drug companies to perform pediatric testing for drugs even if they are labeled for use only by adults. The court will now proceed to consider the plaintiffs’ pending motion for summary judgment.<?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" />


“Judge Kennedy’s decision recognizes that consumers can be hurt by the reduced availability of medical drugs that might result from this unauthorized rule, since FDA can use it to block drugs that had been found safe for adults until its demands for pediatric testing have been met,” said Sam Kazman, CEI’s general counsel.  “Similarly, the rule could restrict the ability of physicians to provide the best medical care for their patients.  All in all, this decision is a major advance for the right of consumers and physicians to protect their medical freedoms.”


The FDA established the pediatric rule in December of 1998.  The agency claimed it was acting to protect children, but in the view of AAPS, CEI, and Consumer Alert, the rule simply adds one more regulatory obstacle to the drug approval process.


AAPS is a non-profit organization of 4,000 physicians dedicated to preserving the practice of private medicine.  CEI and Consumer Alert are non-profit public interest groups involved in opposing government over-regulation.


The Washington, D.C. law firm of Wiley, Rein, & Fielding is handling the case.  Two years ago, the firm won a First Amendment challenge to the FDA’s ban on the distribution of off-label research publications.  Attorney Bert W. Rein stated: “Having overcome FDA’s attempt to define the public interest on its own narrow terms, we now look forward to a prompt disposition of this case on its merits.”



CEI is a non-profit, non-partisan public policy group dedicated to the principles of free enterprise and limited government.  For more information, please contact the media relations department at or 202.331.1010.