Guest Commentary: The FDA’s Ban on Tissue Donations from Queer Men is Outdated and Harmful

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Since 1994, the federal government has rejected deceased-donor tissue donations from queer men if the donor was sexually active with another man in the five years preceding death.

This guest commentary was originally published by the Buckeye Flame and republished here with permission.

Blood donation gets a lot of media coverage, from community blood drives to national shortages. In the past, queer individuals who were turned away for blood donation under the FDA’s ban were able to share their stories. They were able to verbalize their discrimination, tell what happened and use those events as a platform for advocacy. In May of this year, 38 years after the blood ban’s implementation, new policies removed barriers for transgender and nonbinary donors, as well as some queer men (those with <2 sexual partners).

Unfortunately, the ban on donations from queer men doesn’t end with blood donation.

Since 1994, the federal government has rejected deceased-donor tissue donations from queer men if the donor was sexually active with another man in the five years preceding death. Since nearly all donors are deceased at the time of screening, tissue procurement organizations must assume that the queer person has had sex in the past five years and won’t be permitted to donate.

The individuals impacted by this mandate can’t advocate for themselves. It isn’t “deferment” in the same sense of blood donation, where you can try again at a later date. With tissue and organ donation, you only have one chance to give. There is no redo. You can’t put off your death for five more years and remain celibate during that time, nor should you have to.

There is a very high likelihood that no openly queer man who has died in the past 29 years has been permitted to donate his tissues—and the policy is also likely applied to transgender women and nonbinary individuals who were assigned male at birth. Potentially millions of tissues have been rejected.

Because the individuals impacted by this policy can’t share what happened to them, there is a complete lack of awareness. The public is not aware of this policy, and if we aren’t raising an alarm about the discrimination, the FDA has no reason to act.

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Sixteen years late, and still waiting

The FDA revised the five-year ban once before: an expansion to include anonymous sperm donation (ex. through a sperm bank) in 2004. The last time the FDA touched the document was in August 2007—16 years ago. There are 30 sources used to rationalize the ban, citing a risk of HIV and Hepatitis B. Of these 30 sources, not a single one was published after 2001.

Seventeen tests are approved for the testing of tissue donors for HIV and/or Hepatitis B. All 17 were approved after the five-year ban was implemented in 1994. Nine of the 17, over half, were approved after the policy was last amended in 2007.

All 17 tests approved for testing donors of HIV and Hepatitis B are dually licensed for testing blood donors for the same infections. They have been deemed effective enough to decrease the blood donation deferment for queer men from a lifetime policy, to a 12-month policy, to 3-months–and now an individual risk assessment.

If these blood-donor policies are effective enough to earn the FDA’s approval, why are they not effective enough to update the tissue-donor policy?

They are. Tissues are not always seen as “lifesaving” in the same sense as blood products and organ transplants. However, they are often lifesaving for skin grafts in burn patients, as well as for heart valves and stem cells; all of which are regulated by the same FDA policy.

Some tissues aren’t lifesaving, but the transplants have a critical impact on a patient’s quality of life. Corneas can restore sight in recipients. Tendons and ligaments can restore range of motion and independence. Sperm donation allows those who need donor-assisted reproduction to start their families, an issue all the more important for queer families.

FDA doing a disservice

I find it incredibly difficult to believe that the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee has not had any new data related to safety of tissue donation in the past 16 years. During that time, other agencies, centers, and committees have released updated findings and approvals for tests and policies in the fields of transfusion and transplantation.

The FDA has a responsibility to not only ensure safety, but to maintain availability of donations. As long as they elect to turn away healthy donors due to their sexuality, they are doing a disservice to not only the American people, but all those who have the potential to receive tissues procured in the USA. 🔥

Ignite Action

The next CTGTAC meeting will be held on 9/27/23 at 10 am. Pride and Plasma has requested to speak during the opportunity for public comment and will be submitting written evidence and argument for a removal and revision of the five-year MSM deferral criteria for tissue donors. You can sign our petition to help put pressure on the FDA to revise and change the policy.