Federal Judge Rules FDA Lacks Authority To Require Drug Companies To Test Drugs for Use in Children
U.S. District Court Judge Henry Kennedy on Thursday ruled that an FDA regulation that requires pharmaceutical companies to test their products for use in children "exceeds the FDA's statutory authority and is therefore invalid," the New York Times reports (Pear, New York Times, 10/19). In 1997, Congress passed legislation to encourage pharmaceutical companies to test their products in children, and the FDA implemented the Pediatric Rule in 1998 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). In his decision, Kennedy said that the FDA regulation conflicts with two laws -- the FDA Modernization Act of 1997 and the Best Pharmaceuticals for Children Act, enacted in January -- that provide financial incentives for, but do not require, pharmaceutical companies to test their products in children. Kennedy wrote, "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. 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" (New York Times, 10/19). FDA spokesperson Lawrence Bachorik said that the agency has not decided whether to appeal the decision. He added, "We still think it is vitally important that drugs be studied in children so that their safety and efficacy can be determined on the basis of sound data" (Washington Post, 10/19).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.