Summary excerpt from the Statement of the Association of Medical School Pediatric Department Chairs: In the following we wish to emphasize AMSPDC’s agreement with the American Academy of Pediatrics' Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations. In addition we believe that the N.I.H. Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects should be upheld. We further believe, as stated in the FDA's Pediatric Rule, that ‘many drugs and biological products marketed in the United States are inadequately labeled for use in pediatric patients or pediatric sub-groups’. Finally we strongly disagree with the assertion that off-label use of drugs in children that have been approved by the FDA in adults for similar indications constitutes a substitution for scientifically valid investigation of those drugs in children. Since the courts have determined that the FDA does not have the power to enforce ‘the pediatric rule’, we feel it is essential for Congress to pass legislation to enact this rule as soon as possible.