EXECUTIVE SUMMARY Objective

To assess the feasibility of the unrestricted and unlabeled use of blood drawn therapeutically from patients with he-reditary hemochromatosis (HH) in the United States, via a review of the scientific literature, current media reports, and governmental regulations. Data Sources Literature searches on the terms “hemochromatosis,” “blood donation, ” and “voluntary blood donation ” were conducted in the MEDLINE database from 1966 through 1998. Lexis/Nexis news databases were searched for devel-opments in the last 2 years by using the same terms. The World Wide Web was searched by using the key terms “blood donation ” and “hemochromatosis ” and was em-ployed to access the Code of Federal Regulations and the Food and Drug Administration (FDA) to determine regula