The FDA has finalized a recommendation to lift its lifetime ban on men who have sex with men from donating blood, a policy that dated back more than 30 years to the HIV/AIDS epidemic’s early days.
In its place, the agency now recommends that gay and bisexual men refrain from donating blood for 12 months after their last sexual contact with another man (http://1.usa.gov/1NHsc0O). The new guideline now aligns with recommendations for other men and women at increased risk for HIV infection, such as those who recently received a blood transfusion or were accidentally exposed to another person’s blood.
Peter Marks, MD, PhD, deputy director of the FDA’s Center for Biologics Evaluation and Research, noted that the agency “rigorously examined” several alternatives to the lifetime ban, including individual risk assessment prior to donation.
“Ultimately, the 12-month deferral window is supported by the best available scientific evidence, at this point in time, relevant to the US population. We will continue to actively conduct research in this area and further revise our policies as new data emerge,” Marks said in a statement.
Several other countries, including the United Kingdom and Australia, also have 12-month blood donation deferrals for men who have sex with men. An analysis of more than 8 million units of donated blood in Australia showed no increased risk of HIV in the blood supply after blood centers adopted 12-month deferrals (Seed CR et al.Transfusion. 2010;50:2722-2730). Similar data are not available for shorter deferral intervals, the FDA noted.
The new recommendations also advise blood centers to revise their donor education materials, donor history questionnaires, and donor requalification and product management procedures.
During the decades-long course of the HIV/AIDS epidemic in the United States, the FDA noted that transfusion-related HIV transmission has decreased from 1 infection per 2500 transfusions to 1 per 1.47 million transfusions.