FDA issues final guidance on blood donations from MSM
The FDA has released the final version of its blood donation safety guidelines, which allow men who have sex with men to donate if their most recent sexual contact was at least 1 year earlier.
“Relating in large part to the development of more sensitive HIV testing methodologies, there have been calls in the social and scientific literature to revisit the blood donor deferral policies that were established about 3 decades ago, in particular, with regard to the deferral of MSM,” the agency wrote in the guidelines.
“FDA concludes that the available evidence most strongly supports a change from the indefinite deferral to a 1-year blood donor deferral policy for MSM, and FDA expects that this change will maintain or improve blood safety with respect to HIV. FDA will continue to monitor the safety of the blood supply, including the effect of a change to a 1-year deferral.”
Despite this change, the agency continues to recommend that indefinite deferral remain for commercial sex workers and those who inject drugs.
In collaboration with the NIH’s National Heart, Lung, and Blood Institute, the FDA has undertaken the creation of a national blood surveillance system that will allow the agency to monitor the effect of this policy change and to ensure the continued safety of the national blood supply.
FDA. Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products. Guidance for Industry. www.fda.gov. Accessed December 21, 2015.