FDA Eases Restrictions on Blood Donations From Gay Men

FDA changed its recommendation that men who have sex with men be indefinitely deferred from donating blood to 12 months since the last sexual contact with another man.

The original policy had been in place for approximately 30 years.

 “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, M.D., Ph.D., deputy director of the FDA’s Center for Biologics Evaluation and Research. “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.”

Several countries, including the United Kingdom and Australia, currently have 12-month deferrals for MSM. During the change in Australia from an indefinite blood donor deferral policy for MSM to a 12-month deferral, well-conducted studies evaluating over 8 million units of donated blood were performed using a national blood surveillance system. These published studies document no change in risk to the blood supply with use of the 12-month deferral. Similar data are not available for shorter deferral intervals.

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