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 U.S. Food and Drug Administration’s (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.

While the pharmaceutical industry generally accepted the Pediatric Rule, several groups including the Association of American Physicians and Surgeons (AAPS) and the Competitive Enterprise Institute (CEI) remained opposed.  In December 2000, AAPS, CEI, and Consumer Alert filed a lawsuit asking the federal court to overturn the Pediatric Rule, claiming that the FDA overstepped its authority.  Proponents of the Pediatric Rule include the American Academy of Pediatrics (AAP), which filed an amicus brief supporting the rule.

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.