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On December 23, 2014, FDA Commissioner Margaret A. Hamburg announced that the agency favors supplanting the outright ban on blood donations from men who have sex with men (MSM) with a new policy that would prohibit donations from men who have engaged in homosexual activity in the previous 12 months. This shift for MSM would

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The Food and Drug Administration (“FDA”) is considering whether to revise a controversial policy prohibiting blood donations from men who have sex with other men. Dating to 1983, the FDA policy, commonly referred to as the “MSM Deferral Policy,” which prohibits men who have had sex with other men (referred to in medical literature as “MSMs”), at any time since 1977 (ostensibly the dawn of the AIDS epidemic in the United States), from donating blood. While FDA regulations require blood banks to screen potential blood and plasma donors for risk factors related to HIV and other infectious diseases (See 21 C.F.R. § 640.3(b)(6) (2013)), the FDA also has advised blood banks that some potential donors—such as MSMs—are inherently high-risk, and consequently must never be allowed to donate blood. The FDA has explained that this policy is necessary “because MSM[s] are, as a group, at increased risk for HIV, hepatitis B and certain other infections that can be transmitted by transfusion.”

The controversial policy has come under fire from AABB, which argues that it is both medical and scientifically unwarranted and discriminatory. AABB, along with the American Red Cross and America’s Blood Centers, have urged the FDA to abandon the indefinite deferral in favor of a 12-month deferral. Similarly, in 2013, a bipartisan Congressional group challenged the ban by stating that the policy “turn[s] away healthy, willing donors, even when we face serious blood shortages. Further, the existing lifetime ban continues to perpetuate inaccurate stereotypes against gay and bisexual men, and fosters an atmosphere that promotes discrimination and discourages individuals from seeking HIV testing and treatment services.”


Continue Reading FDA May Consider Lifting Controversial Ban on Blood Donations from Men Who Have Sex with Men