Published by Kirby Winn on Thursday, January 26, 2023 in Blog
January 27, 2023: The U.S. Food and Drug Administration has issued draft guidance to change the blood donation deferral of males who have sex with another male. (See FDA news release.) ImpactLife, along with America’s Blood Centers, the Association for the Advancement of Blood and Biotherapies, and blood centers across the country are united in support of evidence-based change to an individual sexual-behavior based screening process for all donors intended to expand blood availability while maintaining blood safety. (See America's Blood Centers news release.)
Once blood centers have been issued the FDA draft guidance, a finalized version will be available after a period of review. At that time, blood centers will have 6–12-months to implement the changes involving modification to donor management software, donor screening and questionnaire protocols that will allow for new donor eligibility. ImpactLife will update communications as information becomes available.
Previous Update (January 2022)
The American Medical Association has issued a statement asking the U.S. Food and Drug Administration to update its blood donor eligibility criteria that prevent many gay and bisexual men from becoming blood donors. The AMA statement of Jan. 26, 2022 has focused attention on the policy that defers men from giving blood if they have had sexual contact with another man in the previous 90 days.
BACKGROUND: The first cases of acquired immunodeficiency syndrome (AIDS) from blood transfusion and plasma derivatives were identified in 1982 and blood collection agencies began deferring men who have had sex with other men soon thereafter. What had long been an indefinite deferral from blood donation was reduced to a 12-month deferral in 2015 and a 90-day deferral in 2020. The policy is often incorrectly referred to an LGBTQ+ “ban” on blood donation. (While the deferral has clear implications for sexually active gay and bisexual men, it does not apply to all members of the LGBTQ+ community.)
WHAT’S NEXT: As the final authority on criteria for donor eligibility, the U.S. Food and Drug Administration has provided funding for research, currently underway, that will help determine the feasibility of alternative deferral policies. The Assessing Donor Variability And New Concepts in Eligibility (ADVANCE) study is evaluating donor screening questions based on individual behavior and risk. The results will help determine how future changes to blood donor eligibility might be implemented. (See: “What’s Next for MSM Deferral Policies?” on the AABB web site - Association for the Advancement of Blood & Biotherapies.)
Pete Lux, RN, is our Vice President, Donor and Patient Services. His work on the AABB Donor History task force places him among a group of blood industry leaders who are sharing their perspective on this issue with FDA. “At ImpactLife, we join in the calls for FDA to update the donor eligibility criteria for men who have sexual contact with other men,” said Lux. “We support evidence-based changes that focus on individual risk, not excluding entire groups of potential donors.”
As a member of America’s Blood Centers, ImpactLife is committed to maintaining a safe and available blood supply and treating all potential donors with fairness, equality, and respect. To that end, we strongly support ongoing research initiatives designed to determine if donor-screening alternatives based on individual behaviors, not based on sexual or gender identity, will provide equivalent or superior transfusion safety.
We encourage the Food and Drug Administration to continue its examination of deferral criteria for men who have had sex with men to ensure the use of rational, science-based deferral periods that are applied fairly and consistently among blood donors.