01/08/2025
FDA proposes removing ban on s***m donation by men who have s*x with men
Over the past 25 years, The S***m Bank of California (TSBC), National Center for Le***an Rights, American Medical Association, American Society for Reproductive Medicine, and others have advocated to allow gay men to donate s***m. Because s***m 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 s***m from men who had s*x 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On January 7, 2025, the FDA published Draft Guidance proposing to change its policy for HIV, HBV, and HCV screening that would follow a gender neutral and individual risk-based approach similar to what is now in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 If finalized as set forth in the Draft Guidance titled “Recommendations To Reduce the Risk of Transmission of Human Immunodeficiency Virus (HIV) by Human Cells, Tissues, and Cellular and Tissue-Based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/q***r 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 Additionally, the Draft Guidance applies a science-based approach to risk reduction, noting that s***m sample quarantine and donor retesting after 6 months further lower any risks.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 s*x with men from donating cells and tissues, including s***m.
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 s*x with men (MSM) and women who have s*x 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 s*x or gender.”
The Draft Guidance is open for public comment until February 6th. 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.
The Food and Drug Administration (FDA or Agency) is announcing the availability of three specific draft guidances for industry entitled "Recommendations to Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps);"...
