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The FDA formally lifted its 32-year ban on blood donations from gay and bisexual men on Monday, but it also left new restrictions in place that still limit who can donate.
According to federal health officials, men who have sex with men, or MSM, can give blood so long as they were abstinent for 12 months prior to donation. The agency said the updated blood donor deferral guidelines reflected the “most current scientific evidence” that still protected blood supplies from HIV contamination.
FDA moves to 12 month MSM deferral for blood donation and commits to working to further progress policy. https://t.co/A7Air7NdlS
— U.S. FDA (@US_FDA) December 21, 2015
The new rule overturns a ban that dates to 1983, when the Aids epidemic was just emerging and many experts were fearful of contaminating the blood supply with a poorly understood disease.
“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, deputy director of the FDA’s Centre 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 US population.”
The ban remains in place for commercial sex workers and people who use injection drugs, because “insufficient data are available to support a change to the existing deferral recommendations at this time”, the FDA said in a statement.
In order to arrive at the decision, the FDA said it “examined a variety of recent studies, epidemiologic data and shared experiences from other countries that have made recent MSM deferral policy changes.”
“These published studies document no change in risk to the blood supply with use of the 12-month deferral,” it said.
People with haemophilia or related clotting disorders are also still barred from donating blood “for their own protection due to potential harm from large needles used during the donation process”, the FDA said.
Agencies/Canadajournal
