The FDA is issuing an interim rule to provide additional safeguards for children enrolled in clinical trials of medical products the agency regulates. This action was mandated by the Children’s Health Act of 2000 that calls for specific measures to better promote the unique needs of children participating in clinical trials.

The new rule is designed to help the agency and clinical researchers address many of the ethical issues that will accompany the expected increase in the enrollment of children in clinical trials. Recent initiatives such as the agency’s 1998 pediatric rule and the pediatric provisions of the FDA Modernization Act of 1997 have encouraged sponsorship of more pediatric clinical trials that can provide vital information about how therapeutic drugs and devices work specifically in children. These data can provide important insight into how these products can be formulated, administered and labeled in ways that maximize their benefit and minimize their risk to children.

Under the new regulation, Institutional Review Boards responsible for maintaining safeguards for clinical trial subjects will now have specific standards for determining whether proposed pediatric clinical trials can be ethically conducted. A key aspect of the new rule sets standards and procedures for assuring that children have assented to participating in clinical trials (when possible), and that their parents or guardians are able to give fully informed consent to the child’s participation in a study. The interim rule will be published in the Federal Register early next week and will become effective five days later. Written comments on the rule can be submitted to FDA for 90 days following its publication at the following address:

Dockets Management Branch (HFA-305)
(HFA-305) Food and Drug Administration
5630 Fishers Lane
Rockville, Maryland 20857