The updated FDA draft guidance employs an individual risk-based approach to reduce the risk for transfusion-transmitted HIV
Feb. 24, 2023 (ACP) — In a move long championed by the American College of Physicians, the U.S. Food and Drug Administration has proposed the elimination of time-based deferrals for blood donation by men who have sex with men (MSM) in favor of gender-inclusive, individual risk-based assessments to reduce the risk for transfusion-transmitted HIV.
“The College is opposed to any and all discrimination in medicine, and we see this change as a step in the right direction in reducing the discriminatory impacts of federal blood donation policy,” said Joshua Serchen, an ACP associate for health policy. The new FDA draft guidance is in line with blood donation policies in other countries, such as the United Kingdom and Canada.
“FDA's action on this issue comes as the nation has experienced significant blood shortages in recent years that have been exacerbated by COVID-related disruptions,” Serchen noted. “While the worst of the shortages appear to be behind us, community blood centers across the nation continue to have critically low levels of blood supply.”
Exactly how much blood will be added to the nation's supply if this guidance is adopted is unknown. A 2014 analysis by the Williams Institute at the University of California-Los Angeles School of Law estimated that lifting the complete ban on MSM donating blood would result in as much as a 4 percent increase in the annual total blood supply, or about 615,300 additional pints of blood, Serchen said.
In 1985, the FDA imposed a lifetime ban on blood donation by MSM due to concerns about a heightened risk for HIV transmission via blood products. These guidelines were updated in 2015 to allow MSM to donate blood if they abstained from sex in the prior 12 months. In 2020, they were further revised to allow MSM to donate blood if they abstained from sex in the prior three months.
“All of these approaches discriminate against MSM as a class, treating all MSM uniformly and categorically, rather than targeting or screening for specific at-risk activities,” Serchen explained. “Advocates and other nonprofits involved in blood donation have long decried these policies as discriminatory, with many pointing out the existing screening capabilities and procedures that donated blood goes through.”
And the FDA listened. “Following its study and review of the data in January, the FDA announced updated draft guidance that takes a more individual risk-based approach,” Serchen said. “Under the proposed update, MSM would be allowed to donate blood if they have had only one or fewer sexual partners in the past three months that were not new sexual partners.” The proposed guidance calls for the current donor history questionnaire to be revised to ask all prospective donors about new or multiple sexual partners in the past three months.
The guidance is not set in stone yet. It must undergo a 60-day public comment period before it is finalized and can go into effect. ACP plans to explore submitting comments on the draft guidance in the weeks to come, Serchen said.
“This draft guidance is set to bring the United States in line with other countries, like the U.K. and France, who screen for high-risk activities at the individual level as part of the donation process rather than impose blanket bans for certain populations,” Serchen said.
ACP has advocated for such changes for some time. In its 2015 policy paper on LGBT health disparities, ACP called for continued reviews of blood donation deferral policies for MSM. ACP supports evidence-based deferral policies that include a comprehensive assessment of the risk level of all individuals seeking to donate, which may result in varying deferral periods or a lengthened or permanent deferral on blood donation.
The FDA draft guidance comes less than a year after ACP called on the agency to expedite the study and implementation of alternative policies that would safely increase the blood donor pool in a way that does not discriminate against donors on the basis of sexual orientation and gender identity.