After more than three decades of government-mandated differential treatment, on January 6 the FDA released updated draft guidelines for tissue donor eligibility for men who have sex with men (MSM).
The new guidelines, which still have to go through further FDA approvals before they are implemented, correct outdated policies that were written in the early 1990s – when the medical community had an incomplete understanding of HIV, and tests for HIV and other infectious diseases (like Hepatitis B) were ineffective.
In 1994, during the height of the HIV and AIDS crisis, the United States government introduced policies to lower the risk of HIV transmission through transplantation of human organs and tissues. This was done mostly through deferral–turning away donors due to risk factors associated with different infectious agents. Of note was a five-year deferral for any sexually active MSMs. This followed a similar policy, which introduced a lifetime deferral (or ban) for MSM blood donors in 1985.
However, while organ and blood donation policies were eased through the 2010s and 2020s, tissue eligibility failed to follow in the footsteps of scientific advances.
The processes for organ and tissue donor registry are one and the same, but the two classifications of biologics are regulated separately. Organs include larger parts of the human body like the heart, lungs, liver, and kidneys. Tissues are smaller components of these organs and organ systems, including skin, bones, heart valves, corneas (the clear part of the eye), tendons and ligaments and reproductive tissues.
When individuals anonymously donate sperm or eggs–reproductive tissue–at a sperm or egg bank, the donor must meet certain requirements. Under the Food and Drug Administration’s current policy, any queer men who were sexually active in the past five years would not be permitted to donate regardless of testing for HIV, hepatitis B and other infections.
With blood donation, donors are living and undergo the screening process themselves. With the exception of reproductive tissue, tissue donors are deceased requiring a potential donor’s next of kin to identify potential risk factors. Not only is the policy discriminatory, it’s ineffective- a third party is expected to know a donor’s comprehensive sexual history for the past five years.
If a potential donor’s next of kin was remotely unsure of the donor’s sexual history over the previous five years, tissue banks would be forced to assume the donor was ineligible. It is possible that no openly queer men have been permitted to donate their tissues in the previous 30 years.
Whole generations of our community have been denied their dying wish to help others by donating their tissues. The impact of this policy cannot be limited to only gay men or cisgender queer men. Although the language of the policy used the terminology of “men who have sex with men” the policy was also likely applied to transgender women, nonbinary people and other gender-diverse individuals.
Pride and Plasma was founded to fight the FDA’s discriminatory blood ban, but as we researched that policy, we became aware of the longer and lesser-known tissue ban. One of the larger barriers to advocacy with the tissue ban was public awareness. While we had testimony from potential donors who were turned away with blood donation, tissue donors are almost always deceased at the time of eligibility determination and unable to share the experience of discrimination.
Pride and Plasma researched the policy, tissue donation regulation, global policies, the effectiveness of testing mechanisms and scientific advances over the past 30 years. We compiled this research into a brief and submitted it, with subsequent updates to the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee, three times between 2023 and 2024.
The updated policy makes significant progress and is directly in line with Pride & Plasma’s recommendations submitted in our research briefs. Further, the new policy is identical to blood donor eligibility criteria finalized in May 0f 2023, as well as tissue policy from the United Kingdom. Additionally, the updated policy has removed all gendered language, which may promote equitable screening of gender-diverse donors. If the draft guidelines are adopted, rather than any sexual activity even once with another man in the past five years, donors will be screened for the following risk factors for HIV, Hepatitis B and Hepatitis C:
- Any new sexual partners and anal intercourse within the past three months OR multiple sexual partners and anal intercourse within the past three months.
- Medications to prevent HIV (PrEP, PEP), including oral medications within three months and injectable medications within two years. These medications interfere with the effectiveness of HIV testing, as they do not eradicate the virus immediately, but they prevent replication. There is a risk that the medications would prevent the viral load within an individual from replicating to the point of infection, but remaining at a non-zero undetectable level. This is the same rationale as deferment for individuals who have taken medications to treat other STIs, where the medications interfere with accurate detection of the infectious agent.
These new criteria will certainly have an impact upon members of the LGBTQ+ community, but will not target them in the same way that the previous policy did.
Pride and Plasma will continue to research practices and review available data to lobby the FDA to ensure that all safe and healthy individuals are permitted to donate if that is their wish. 🔥
IGNITE ACTION
- The FDA is accepting comments from the public, stakeholders, and invested parties through February 6th, 2025 at 11:59pm. We need your help to ensure that this policy goes from a draft, to finalized guidance, to implemented practice. You can submit comments to the FDA on the draft policies here:
- Review the draft policies here.
- Register as an organ and tissue donor here
- Read Pride & Plasma’s research brief submitted to the FDA here.
- Read Pride & Plasma’s research brief for the public, with additional background and supplemental information, by going here.
- Find a blood bank near you and make an appointment to give here.
- Visit Pride and Plasma’s website here and follow them on socials here.
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