The United States Food and Drug Administration (FDA) decided to change its policy that prohibits gay men from donating blood for 30 years after their last sexual contact with another man. The ban was implemented to prevent the transmission of human immunodeficiency virus (HIV) by blood and blood by-products. HIV causes AIDS.
Today, the FDA issued a final guidance regarding its blood deferral recommendations, which indicated that game men can now donate blood 12 months after their last sexual contact with another man.
The FDA said its policy change reflects the most current scientific evidence and to help ensure the continued safety of the blood supply by reducing the risk of HIV transmission.
FDA reviews blood deferral policies based on current scientific evidence
In a statement, FDA Acting Commissioner Stephen Ostroff, M.D. said, “The FDA’s responsibility is to maintain a high level of blood product safety for people whose lives depend on it. We have taken great care to ensure this policy revision is backed by sound science and continues to protect our blood supply.”
The agency determined the appropriate changes by reviewing its policies regarding HIV transmission through blood products based on the most recent scientific evidence. The FDA said it will continue to re-evaluate its blood donor deferral policies in the future as new scientific evidence becomes available.
Peter Marks, M.D., Ph.D., deputy director of the FDA’s Center for Biologics Evaluation and Research, said, “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.”
“Ultimately, the 12-month deferral window is supported by the best available scientific evidence, at this point, 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,” added Dr. Marks.
FDA reduces HIV blood transmission rates significantly
The use of best available science, donor education materials combined with specific deferral questions and advances in HIV donor testing helped the FDA reduced the HIV transmission rates from blood transfusions from 1 in 25000 to 1 in 1.47 million.
The FDA evaluated a variety of new studies, epidemiologic data, and shared experiences from other countries that recently implemented policy changes on blood donations by men who have sex with men (MSM).
According to the agency, several countries including Australia and the United Kingdom currently have the 12-month ban on blood donations by MSM. Australia previously had indefinite blood donor deferral policy for MSM but decided to change it after performing studies and evaluating more than eight million units of donated blood using a national blood surveillance system.
The FDA said published studies documented no change in risk to the blood supply with the implementation of the 12-month deferral.
Additionally, the FDA said its new blood deferral policy recommends that blood establishment should make corresponding revisions to donor educational materials, donor history questionnaires and accompanying materials, as well as donor requalification and product management procedures.
Furthermore, the updated deferral policy also reflect a change in the rationale for deferring people with hemophilia or related clotting disorders who have received clotting factor concentrates. Potential donors with hemophilia or related clotting disorders were previously prohibited due to the increased risk of HIV transmission to potential recipients.
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 based on new scientific evidence.