The Food and Drug Administration has relaxed its 32-year ban on blood donations from gay men. The ban was originally introduced in 1983 to protect people receiving blood transfusions from people infected with HIV.
The FDA’s announcement on Monday lifting the ban comes with a caveat, however: Gay and bisexual men can only donate blood after having no sexual contact with another man for over a year.
“The FDA’s responsibility is to maintain a high level of blood product safety for people whose lives depend on it,” said the FDA’s Acting Commissioner Stephen Ostroff, M.D. “We have taken great care to ensure this policy revision is backed by sound science and continues to protect our blood supply.”
The FDA reviewed its policies regarding HIV transmission through blood products to determine appropriate changes based on the most recent scientific evidence. Moving forward, the FDA will continue to reevaluate its blood donor deferral policies as new scientific information becomes available.
As part of today’s finalized blood donor deferral guidance, the FDA is changing its recommendation that men who have sex with men (MSM) be indefinitely deferred – a policy that has been in place for approximately 30 years – to 12 months since the last sexual contact with another man. These updated recommendations better align the deferral period for MSM with the deferral period for other men and women at increased risk for HIV infection – such as those who had a recent blood transfusion or those who have been accidentally exposed to the blood of another individual. The FDA examined a variety of recent studies, epidemiologic data, and shared experiences from other countries that have made recent MSM deferral policy changes.
“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.”