Anal Sex? Open Relationships?The Truth About the FDA's Revised Gay Blood Ban

The federal Food and Drug Administration recently proposed changes to blood donation policy to replace the deferral for sexually active gay and bisexual men with an individual risk assessment applied to all potential blood donors regardless of sexual orientation or gender. This move from an identity-based deferral to one based on a potential donor’s recent sexual activities is a transformative change in the FDA’s management of blood safety and marks the end of the overtly discriminatory policy that has been in place for 35 years.

The FDA’s capitulation should be heralded as a significant if long overdue victory in LGBTQ civil rights. Instead, misconceptions regarding the basis for the now discarded identity-based deferrals, the fitful way the FDA updated the policy over the past decade, rhetoric used to argue against the discriminatory policy, and imprecise communications rolling out the new policy all combined to obscure the historic nature of the change and to temper celebration of the victory.

When the FDA first recommended deferring “sexually active gay and bisexual men with multiple partners” in 1983, little was known about AIDS beyond that it was deadly, the majority of those affected were gay men, and it could be transmitted sexually and via blood transfusion. Given the substantial number of blood/plasma users diagnosed by 1985, the indefinite deferral for all gay and bisexual men implemented at that time was the only practical way to reestablish the safety of the blood supply.

Almost simultaneously, HIV was identified as the cause of AIDS and, shortly thereafter, scientists developed the first test to detect HIV antibodies in blood. All blood donations could now be tested to ensure the donor did not have HIV. However, this test sometimes resulted in a false negative if the donor was recently infected. Deferrals, therefore, were still needed to ensure the blood of people infected within the previous six months — referred to as the “window period” — did not end up in the blood supply.

Those deferrals, however, only needed to cover the window period, with a “cushion” to account for faulty memory or the unusually late false negative, and the FDA started using 12-month deferrals for some risk categories in 1992. But the lifetime deferral for gay and bisexual men continued. Without a valid reason for a deferral of more than a year, the policy became discriminatory. Over time, more sensitive tests were developed, and the window period was reduced to 9-11 days. Nonetheless, the deferral for gay and bisexual men remained lifelong.

In addition to significantly reducing the window period, scientists soon established that some activities, such as oral sex, present little to no risk of HIV transmission and others, such as receptive anal sex, present 13 times the risk (or more) of vaginal sex. That is why, in the early 2010s, advocates began calling for an individual risk assessment inquiring about specific sexual activities and a deferral of no more than 60 days for those that assessment determined to be at higher risk.

Unfortunately, those calls went unheeded. Instead of taking swift action based on well-established science, the FDA slow-walked the process by maintaining the focus on gay and bisexual men and first studying a five-year deferral (2012), and then a one-year deferral (2014), and then implementing a one-year deferral (2015), and then — when the blood supply ran short during COVID — implementing a 3-month deferral (2020).

This sudden shift in stance merely confirmed in the eyes of many that the FDA’s intransigence was never based on significant risk to the blood supply or the need for more data. And tellingly, after 2015, there was no longer a deferral for transgender women, among whom HIV prevalence is higher than for gay and bisexual men. The policy had become completely untethered from the science, and the FDA lost credibility continuing to defend it.

That is why the proposed changes announced in late January are monumental: deferrals will finally be based on the science of HIV transmission and will be applicable to every blood donor, not just to gay and bisexual men. Essentially anyone who has anal sex with new or multiple partners in the previous three months will be deferred. And though the current science also supports an even shorter deferral and only for those who have had receptive anal sex with a new or multiple partners, those refinements can be made down the line. The change to deferral based on individual risk assessment — and not sexual orientation — is the critical turning point to a fair, inclusive, and non-stigmatizing policy.

But even this transformational change is not without its miscues and controversies; resulting in these three contrarian statements:

Contrary to some media accounts, the proposed changes are not simply for people in monogamous relationships; they are instead rooted in one’s number of anal sex partners. Having one sex partner makes a person monogamous, but it does not put that person in a monogamous relationship. Lots of people who think they are in a monogamous relationship are not. And though this will be a constriction of the current policy for heterosexuals, a donor can have multiple partners for all kinds of non-anal sex and still donate blood.

Contrary to statements from some advocates, continuation of the bar for people currently taking PrEP — a daily medication to prevent HIV — is not discriminatory. Discrimination is one group treated differently from another group without a valid reason. PrEP, a great HIV prevention tool, may cause a false negative test result when a person’s blood is tested post donation. Understandably, the continued inability to donate is frustrating for gay and bisexual men who are taking PrEP; but the potential false negative is a valid reason for maintaining this deferral. Donating in contravention of this rule is a donor unilaterally deciding they are not at risk and that their blood does not need to be tested like everyone else’s — but it does. Until the FDA establishes a way to confirm a PrEP user’s HIV-negative status at time of donation, PrEP users need to forego donating.

Contrary to some well-meaning but confused people, people living with HIV also cannot donate blood, no matter how much their viral load is suppressed by effective treatment. Though it indeed is not possible for an HIV-positive person with an undetectable viral load to transmit HIV sexually — a concept popularized as “Undetectable = Untransmittable” or “U=U” — the same does not hold true for blood donation. Even a person with an undetectable viral load has HIV in their blood — and when a large enough amount of blood is infused directly into another person’s circulatory system, HIV transmission will possibly occur. At least for now, people living with HIV will also need to find other ways to be of service.

For years, the LGBTQ community cried: “Science Not Stigma” and “Follow the Science!” Now that the FDA is (finally) doing just that, the community needs to follow its own advice. The past 35 years have demonstrated that good things come to those who wait, and if patience can be exercised just a bit longer, a good thing called “pathogen inactivation” will make safe blood donation possible for everyone! Let’s celebrate that — and the elimination of a discriminatory policy before it was rendered moot.

Scott A. Schoettes is an attorney and advocate who lives openly with HIV. He engages in impact litigation, public policy work, and education to protect, enhance, and advance the rights of people living with HIV.

(Editor's note: A previous version of this article referred to the FDA as the Federal Drug Administration. The FDA is the Federal Food and Drug Administration.)