US FDA Final Rule on Pediatric Labeling

The US Food and Drug Administration has published a rule aimed at making it easier for manufacturers of drugs and biologics to include information about a product's use in children from birth up to the age of 16 on the product's label, and to obtain approval for such use.

The final rule, originally proposed in October 1992 and published in the Federal Register last month, is entitled Specific Requirements on Content and Format of Labeling for Human Prescription Drugs; Revision of "Pediatric use" Subsection in the Labeling. it takes effect on January 12, 1995. The FDA has told companies that they have until December 1996 to "re-examine existing data to determine whether the 'Pediatric use' subsection of the labeling can be modified, based on adequate and well-controlled studies in adults and other information supporting pediatric use, and if appropriate, submit a supplemental application" to comply with the new rule. "A sponsor who does not believe that the disease and drug effects are similar in the pediatric and adult populations, or who believes that use in pediatric patients is otherwise not adequately supported by data, should not propose revised labeling," it continues, adding that the sponsor "need not inform the agency of this conclusion."

The agency is also to set up a special pediatric subcommittee of the Center for Drug Evaluation and Research medical policy coordinating committee, which will track the implementation of the new regulations, draft policies and guidance documents, to ensure the possibility of pediatric testing and use are explored during development of new drugs. The subcommittee will be chaired by Rosemary Roberts of the Division of Anti-infective Drugs.