Blood Assurance Reacts To FDA's Draft Guidance That Will Allow Many Gay And Bisexual Men To Donate Blood

  • Friday, January 27, 2023

After a years-long effort by blood centers and key stakeholders in the LGBTQ+ community, the Food and Drug Administration has updated its guidance as it relates to gay and bisexual men donating blood.

The updated guidance would establish blood donor screening criteria based on individual risk behaviors, not sexual or gender identity. All potential donors will now be asked if they’ve had new or multiple sexual partners over the last three months. If they respond affirmatively, they’ll be asked if they’ve engaged in anal intercourse with any of their partners. If the answer is yes, they will be deferred for three months. Individuals in long-term relationships (more than three months) with one partner will no longer be deferred. 

“The blood supply has never been safer,” said Dr. Liz Culler, chief medical officer for Blood Assurance. “Blood Assurance strongly supports the use of rational, science-based deferral periods that are applied fairly and consistently among blood donors who engage in behaviors that pose similar risks.” 

In 1983, the FDA instituted a lifetime deferral on blood donations for gay and bisexual men in order to reduce the risk of HIV in the blood supply. In 2015, the FDA revised the policy to a one-year deferral since last sex between men. In 2020, the deferral was revised again to the current three-month deferral since last sex between men.

“Only 3 percent of Americans donate blood each year. We are hopeful that this change will dramatically increase the donor base and ensure we have enough blood on the shelf to meet demand,” according to Dr. Culler. 

The new draft guidance will not be immediately effective. After a comment period, a final version of the guidance will follow and must be issued before any changes are made that would allow Blood Assurance to welcome previously deferred donors. Additionally, after the guidance is finalized, the blood center must undertake extensive changes, including updating computer systems and donor history questionnaires, likely taking no more than six months. 

Potential donors should also note that those who take Pre-Exposure Prophylaxis (PrEP), regardless of gender or sexual orientation, will still be deferred due to the medication’s interference with routine donation tests that ensure the safety of the blood supply.

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