FDA updates blood donor deferral recommendations to help ensure continued safety of blood supply

Dec 22 2015

Today, the U.S. Food and Drug Administration issued final guidance outlining updated blood donor deferral recommendations to reflect the most current scientific evidence and to help ensure continued safety of the blood supply by reducing the risk of human immunodeficiency virus (HIV) transmission by blood and blood products.

"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.

Using the approach of following the best available science together with use of donor education materials, specific deferral questions and advances in HIV donor testing has helped the FDA reduce the HIV transmission rates from blood transfusion from 1 in 2,500 to 1 in 1.47 million.

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."

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.

The guidance also 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. Additionally, this guidance reflects a change in the rationale for deferring people 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.

Throughout the process of comprehensively 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 carefully 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 critical information to help inform future actions that the FDA may take on blood donor policies. Moving forward, the FDA will continue to reevaluate and update its blood donor deferral policies as new scientific information becomes available.