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FDA proposes removing ban on sperm donation by men who have sex with men

Over the past 25 years, The Sperm Bank of California (TSBC), National Center for Lesbian Rights, American Medical Association, American Society for Reproductive Medicine, and others have advocated to allow gay men to donate sperm.  Because sperm is collected from living donors and can be frozen, quarantined and then retested, this provides a layer of safety not feasible with other cells and tissues. Nonetheless, in 2007, FDA published the “Donor Eligibility Guidance” for human cells and tissues prohibiting the donation of sperm from men who had sex with another man within the previous 5 years, well beyond the testing window for HIV.  This guidance in effect ensured that gay men could not donate.

On January 7, 2025, the FDA published Draft Guidance proposing to change its policy for HIV, HBV, and HCV screening that would follow a gender neutral and individual risk-based approach similar to what is now in practice for blood donation.  If finalized as set forth in the Draft Guidance titled “Recommendations To Reduce the Risk of Transmission of Human Immunodeficiency Virus (HIV) by Human Cells, Tissues, and Cellular and Tissue-Based Products,” the ability for gay/bi/queer men, transwomen, and nonbinary people to donate cells and tissues, including reproductive donation will significantly improve. Additionally, the Draft Guidance applies a science-based approach to risk reduction, noting that sperm sample quarantine and donor retesting after 6 months further lower any risks.  If and when finalized, the FDA donor screening guidance will remove the prohibition against men who have sex with men from donating cells and tissues, including sperm.

As stated in the background section of the Federal Register announcement: “Based on FDA review of the available science, adequacy of available test methods, studies used to evaluate risk behaviors, and experiences with updated blood donor screening questions, FDA also recommends eliminating the HCT/P donor screening questions specific to men who have sex with men (MSM) and women who have sex with MSM and, instead recommends assessing HCT/P donor eligibility using the same individual risk-based questions relevant to HBV, HCV, and HIV risk for every donor regardless of sex or gender.”

The Draft Guidance is open for public comment until February 6^th. After the public comment period closes and FDA has an opportunity to consider the comments, FDA will determine whether to finalize it and when to implement it.  Comments can be made in support of this change as well as making additional suggestions.  We encourage comments supporting this gender-neutral, individual risk-based approach to replace the prior identity-based prohibition.

1/7/25