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The US Food and Drug Administration (FDA) has issued a final guidance outlining updated blood donor deferral recommendations.
As part of the guidance, the FDA is changing its recommendation that men who have sex with men (MSM) be indefinitely deferred from donating blood—a policy that has been in place for approximately 30 years.
Now, the agency is recommending that MSMs be deferred for 12 months since their last sexual contact with another man.
The FDA’s guidance also reflects a change in the rationale for deferring potential blood donors with hemophilia or related clotting disorders who have received clotting factor concentrates.
The FDA recommends that blood establishments make corresponding revisions to donor educational materials, donor history questionnaires, and accompanying materials, as well as donor requalification and product management procedures.
MSM deferral
The FDA said its recommendation regarding MSM blood donors reflects the most current scientific evidence and will help ensure continued safety of the blood supply by reducing the risk of human immunodeficiency virus (HIV) transmission by blood and blood products.
The agency also said this recommendation better aligns the deferral period for MSMs 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.
Before issuing this guidance, the FDA reviewed its policies regarding HIV transmission through blood products to determine appropriate changes based on the most recent scientific evidence. The agency examined a variety of 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, MD, PhD, 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 US population. We will continue to actively conduct research in this area and further revise our policies as new data emerge.”
Several countries, including the UK and Australia, currently have 12-month deferral policies for MSM blood donors.
During the change in Australia from an indefinite blood donor deferral policy for MSMs to a 12-month deferral, studies evaluating over 8 million units of donated blood were performed using a national blood surveillance system. These studies (CR Seed et al, Transfusion 2010; TTA Lucky et al, Transfusion 2014) show no change in risk to the blood supply with use of the 12-month deferral.
A study conducted in the UK produced similar results, although it also suggested that 3 in 10 MSMs don’t comply with the 12-month deferral policy.
And a study conducted in Canada, which recently shortened its MSM deferral period to 5 years, showed no change in risk to the blood supply with the 5-year deferral as compared to indefinite deferral. Based on these results, Canadian regulators are considering changing to a 12-month deferral period as well.
Patients with clotting disorders
The FDA’s new guidance also reflects a change in the rationale for deferring patients with hemophilia or related clotting disorders who have received clotting factor concentrates. Previously, potential donors with hemophilia or related clotting disorders were deferred due to the increased risk of HIV transmission to potential recipients.
Based on new scientific evidence, these potential donors are still deferred, but not due to the risk of HIV transmission—instead, for their own protection due to potential harm from large needles used during the donation process.
FDA policies and actions
Throughout the process of updating blood donor deferral policies over the past several years, the FDA has worked with other government agencies, considered input from external advisory committees, reviewed comments from stakeholders to its May 2015 draft guidance, and examined the most recent available scientific evidence to support the current policy revision.
The FDA has also implemented a nationally representative safety monitoring system for the blood supply with assistance from the National Heart, Lung and Blood Institute at the National Institutes of Health. This system will provide information to help inform future actions the FDA may take on blood donor policies.
The FDA said it will continue to reevaluate and update its blood donor deferral policies as new scientific information becomes available.
