FDA lifts ban on blood donation by gay and bisexual men January 15, 2016 General California Phyhsician's Legal Handbook, Food and Drug Administration, Blood Donation 0 The U.S. Food and Drug Administration (FDA) has released final rules that ease restrictions on blood donations by gay and bisexual men. The new rule allows gay and bisexual men to donate blood if they have not had sex with a man for one year. Previously, the FDA banned all blood donations from men who have had sex with another man since 1977. The previous FDA regulations stipulated that gay men were "deferred as blood donors ... because as a group, [they were] at increased risk for HIV, hepatitis B and certain other infections that can be transmitted by transfusion." The rule had not been updated since 1992. In making this new rule, the FDA considered a shorter deferral period, but opted for the one-year delay because there is a body of research on this time frame. According to the FDA, studies have not yet evaluated the safety of shorter deferral periods. “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," Peter Marks, M.D., Ph.D., deputy director of the FDA’s Center for Biologics Evaluation and Research, wrote in a statement. In October 2012, the California Medical Association (CMA) House of Delegates adopted Resolution 108-12, which supports the use of rational, scientifically based deferral periods for blood donations, applied based on level of risk rather than on sexual orientation. The resolution called on CMA to oppose the FDA-mandated lifetime deferral on blood donations from men who have sex with men. For more information on the new rule, click here. Contact: Samantha Pellon, (916) 551-2887 or spellon@cmanet.org. Comments are closed.
