FDA publishes draft guidance on children

The US Food and Drug Administration has published, in the Federal Register, a draft guidance for clinical investigators on the agency's review process for drug trials involving children.

Under the draft guidance, institutional review boards are obliged to review clinical trials that employ children. Approval should only be given if they meet a detailed risk-benefit calculus and the approvals obtained of children as well as their parents and/or guardians. The FDA suggests that these requirements could be set aside if the IRB could demonstrate that the clinical trial would help "to understand, prevent or alleviate" a serious childhood health disorder. The FDA Commissioner's approval would also be required in such cases, to ensure that ethical practices are followed.

Requests for FDA approval of a clinical trial involving children would be reviewed at a public meeting of the Pediatric Advisory Committee, which recommends a decision to the Commissioner. The latter's decision would be final.