FDA Invites Comments on Proposal to Revise Lifetime Deferral on Blood Donation by Gay Men

Content From: Ronald Valdiserri, M.D., M.P.H., Deputy Assistant Secretary for Health, Infectious Diseases, and Director, Office of HIV/AIDS and Infectious Disease Policy, U.S. Department of Health and Human ServicesPublished: May 18, 20151 min read



In a Federal Register notice published Friday, May 15, 2015, the Food and Drug Administration (FDA) is inviting public comments on the following draft recommendations: Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products .

This draft guidance, to establishments that collect blood or blood components, proposes a policy change to the blood donor deferral period for men who have sex with men (MSM) from indefinite deferral to 1 year since the last sexual contact. The indefinite deferral was first put in place in 1985, due to the strong clustering of AIDS illness in the MSM community. On April 23, 1992, the FDA issued a memo which contains the current recommendations regarding deferral for MSM and other persons whose behaviors are associated with high rates of HIV exposure.

In order to ensure that the FDA considers your comments on this draft guidance before it begins work on the final version of the guidance, please submit either electronic or written comments on the draft guidance by July 14, 2015.