CA hails court decision on Pediatric Rule.

The U.S. Circuit Court for the District of Columbia struck down in October the Food and Drug Administration's "Pediatric Rule," citing the agency's lack of statutory authority. The move means consumers will be able to buy new pharmaceuticals both sooner and cheaper, and many more children won't be drafted for clinical trials on drugs that haven't been used widely.

Consumer Alert, the Competitive Enterprise Institute, and the Association of American Physicians and Surgeons filed suit against the FDA in December 2000 (AAPS, Inc., et al vs. United States Food and Drug Administration, et al.), charging FDA was not authorized to issue the rule under the Food and Drug Administration Modernization Act passed by Congress in 1997 (nor under the follow-up law, the Best Pharmaceuticals for Children Act of 2002).

The decision, issued by Judge Henry H. Kennedy, Jr., stated bluntly, " ... the Pediatric Rule exceeds the FDA's statutory authority and is therefore invalid."

Using the Pediatric Rule, the FDA unilaterally seized authority to decide which drugs are to be labeled for pediatric use, and to order drug companies to conduct clinical trials on children to determine the drug's proper use. This is a turn-around from accepted practice. Since the first federal drug regulations were passed in 1906, it is the drug manufacturer, not the FDA, that determines the "intended use" of a drug. That intended use incorporates both the medical condition the drug would address as well as the patients for whom the drug was designed and tested.

Under the Pediatric Rule, even when a drug is developed with no intended pediatric use, manufacturers, before introducing the drug, would have to test the drug on children. This additional layer of pre-market testing will drive up pharmaceutical costs for consumers, as well as delay the introduction of new drugs to the consumer market--all with little, if any, benefit to children. The rule, through its requirement for pediatric testing at earlier stages, could increase risks to children.

The court decision picked up on plaintiffs' argument that the FDAMA and the BPCA set up voluntary programs for pediatric studies of drugs and incentives for those studies when drugs were not explicitly marketed for children's use. In contrast, the FDA through the Pediatric Rule issued in 1998 required mandatory testing and enforcement through FDA refusal to approve a new drug if a manufacturer did not conduct those studies. The decision noted, "Congress adopted an incentive scheme while the FDA adopted a command and control approach.... Far from complementing Congress's voluntary incentive scheme, the Pediatric Rule usurps it by superimposing an often-incompatible regime."