Pediatric AIDS Foundation, American Academy of Pediatrics File Federal Court Motion to Defend FDA Pediatric Drug Research Rule on Appeal

The Elizabeth Glaser Pediatric AIDS Foundation and the American Academy of Pediatrics filed a motion in federal court on Thursday requesting the right to defend the FDA's Pediatric Rule by appealing an October decision that "struck down" the agency's requirement that drug companies test medicines in children, as the FDA has not yet decided whether to appeal (AAP/EGPAF release, 12/6). U.S. District Judge Henry Kennedy in October ruled that the regulation, which requires pharmaceutical companies to test their products for use in children, "exceeds the FDA's statutory authority and is therefore invalid" (Pear, New York Times, 10/19). In 1997, Congress passed legislation to encourage pharmaceutical companies to test their products in children, and in 1998 the FDA implemented the Pediatric Rule to enforce the law. Although the number of treatments tested in children has increased and pharmaceutical companies have "generally accepted" the rule, the Competitive Enterprise Institute, the Association of American Physicians and Surgeons and Consumer Alert filed suit against the FDA, arguing that the regulation "improperly expanded" the agency's authority (Kaufman, Washington Post, 10/19). Kate Carr, president and CEO of the foundation, said, "The October ruling was a devastating blow to children's health. We need to restore this policy as soon as possible so we can guarantee that children receive the same information about the safety and dosing of drugs that we demand for ourselves as adults." Dr. Richard Gorman, chair of the AAP's committee on drugs, said that the organizations are "committed to pursuing all avenues for permanently reinstating" the Pediatric Rule, and that in addition to the legal filing they will continue to work on federal legislation to codify the rule. A judge must decide whether to grant the two organizations the right to appeal the decision. The FDA has until Dec. 16 to decide to appeal the decision on its own (AAP/EGPAF release, 12/6).