The Food and Drug Administration (FDA) announced this week that the indefinite deferral for blood donors based on sexual history has been modified.
The FDA states that men who have engaged in same-sex activity are no longer placed on an indefinite deferral, but instead on a one-year deferral. According to the announcement, this is similar to recommendations for what the FDA considers groups that are or were at greater risk for acquiring HIV, which includes those who have recently had a blood transfusion and those who have otherwise come into contact with another person’s blood.
“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,” Dr. Peter Marks, deputy director of the FDA’s Center for Biologics Evaluation and Research, said. “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.”
The former policy has been in effect for approximately 30 years. With this change in recommendation, the FDA states that blood donation centers should revise materials associated with education and donor history forms.This change also impacts the deferral of those with hemophilia and other clotting disorders, and indicates that deferrals for these individuals remain in place due to the risks associated with the needles used in the donation process.
The U.K. and Australia also have 12-month deferral policies for individuals who have engaged in same-sex activity.
