FDA Revises Blood Donation Policy for Gay Men

After a 32-year ban, the U.S. FDA has updated its final guidance on blood donation policies for gay men. Men who have sex with men (MSM) may now donate blood, though the ruling requires that MSM be sexually abstinent for 12 months prior to blood donation. Since 1983, shortly after the onset of the AIDS epidemic, the U.S. FDA advised blood centers to refuse donations from gay men for fear of contaminating the blood supply. Since then, the U.S. FDA has been reviewing its policies regarding HIV transmission through blood products to reflect more up-to-date scientific evidence.

In May 2015, the FDA issued a formal proposal recommending ending the ban; the recent action marks the official acceptance of this proposal.

“In reviewing our policies to help reduce the risk of HIV transmission through blood products, we rigorously examined several alternative options, including individual risk assessment,” said Peter Marks, MD, PhD, deputy director of the Center for Biologics Evaluation and Research at the U.S. FDA. “Ultimately, the 12-month deferral window is supported by the best available scientific evidence, at this point in time, relevant to the U.S. population. We will continue to actively conduct research in this area and further revise our policies as new data emerge.”

Critics, including the lesbian-gay-bisexual-transgender (LGBT) community, object to the 12-month deferral requirement, arguing that current blood donation testing detects all known serious bloodborne pathogens, including HIV, within 45 days of exposure. A shorter deferral window of two months or less would be suitable, the LGBT community argues. Other countries, including the United Kingdom and Australia, have 12-month deferrals for blood donations from MSM.

The FDA issued additional guidance recommending that blood centers make corresponding revisions to donor educational materials, donor history questionnaires, and accompanying materials, as well as donor requalification and product management procedures.

Sources: U.S. FDA news release, December 21, 2015; U.S. FDA, “Revised recommendations for reducing the risk of human immunodeficiency virus transmission by blood and blood products – questions and answers.”