In 1998, the Pediatric Rule was implemented that required drug manufacturers to study the efficacy and safety of their products in children or risk denial of FDA approval. The Rule also required manufacturers to devise formulations of drugs for use in children. The regulations applied to all drugs that may be used in children even if the drug manufacturer does not request approval for use in children.

On Oct. 17, 2002, federal district court Judge Henry H. Kennedy, Jr. struck down the FDA Pediatric Rule, holding that the agency had overstepped its authority.