Last week, the U.S. Food and Drug Administration finalized a long-overdue update to its blood donor eligibility policy, most notably a move that “eliminates time-based deferrals and screening questions specific to men who have sex with men.” Now all prospective donors, regardless of sexual orientation, will be asked risk-based questions that aim to reduce the likelihood of blood donation from someone with a new or recent HIV infection. These updated recommendations have been heralded in the news and by advocates alike as an end to the so-called “gay blood ban.” But is that true?
In the 1980s, during the early years of the AIDS epidemic, the FDA implemented a lifetime ban on blood donation from any man who had sex with another man since 1977 (along with a ban on other groups including sex workers and people who inject drugs) to prevent HIV from entering the blood donation pool, especially in the absence of the type of highly sensitive and specific tests we have today. A byproduct of this blanket ban was further stigmatization of groups most affected by the epidemic, a predictable consequence when the FDA chose to focus on entire groups of people rather than on specific sex acts and the associated likelihood of HIV transmission. The ban was relaxed to a one-year deferral period in 2015, and then to three months in 2020, amid blood shortages during the COVID-19 pandemic. Now, the updated policy removes references to sexual orientation entirely and instead directs that “all prospective donors who report having a new sexual partner, or more than one sexual partner in the past three months, and anal sex in the past three months, would be deferred” from donating, per the FDA’s news release.
But the updated recommendations also include an additional, puzzling deferral criterion: People who use HIV pre-exposure prophylaxis, or PrEP, are not eligible to give blood. PrEP is the use of HIV antiretroviral medications as either pills or injections for HIV-negative people to prevent them from acquiring HIV. The medications are highly effective—indeed, more than 99 percent effective when taken as prescribed—and are currently our most crucial defense against the spread of HIV. But the FDA says potential blood donors must delay donation for three months from their last dose of oral PrEP or two years from last injection, even though it recognizes that PrEP is “safe, effective, and an important public health tool.” In fact, the FDA explicitly does not recommend anyone go off PrEP to donate blood.
So why is the FDA targeting PrEP users? It seems the agency’s main concern is that the drugs could lead to false-negative HIV screening tests in blood donations, meaning a test shows a donation does not have HIV when it actually does. While it is true that PrEP use may delay HIV detection—for example, in someone who acquired an undetected HIV infection shortly before going on PrEP—this has only been documented in antibody and antigen tests. All donated blood is also screened using nucleic acid testing (NAT), which looks for HIV RNA, genetic material that shows up sooner in the seroconversion process than antibodies or antigens. A paper from authors affiliated with the Australian Red Cross specifically focused on HIV and blood donation determined such rare infections are highly likely to be caught early with NAT tests.
If it is likely that NAT would catch early HIV infections associated with PrEP use, then we deserve far more transparency about why the FDA has decided to continue to bar PrEP users from blood donation. In its news release, the agency does not explicitly point to any data; instead, it says it has “reviewed numerous data sources,” apparently including the NAT tests. To bring at least some credibility to its exclusion of PrEP users, the FDA has a responsibility to be clear about what data it used. As Joseph Osmundson, a clinical assistant professor of biology at New York University, told me, “The burden should be on the FDA to produce models of what they think is happening.” So far, the agency has failed to provide it.
Now, only HIV-negative gay, bisexual, and other men who have sex with men who do not use PrEP and who are abstinent from anal sex for at least three months, or are in a sexually monogamous relationship (or believe themselves to be), are able to donate blood. But no one is tested for HIV more often than PrEP users, who are screened every three months as part of taking the medication. The blanket ban excludes a large group of people who have more current information about their HIV status than almost anyone else in the country.
Anyone can take PrEP regardless of sexual orientation—and anyone who thinks it may be right for them should speak with their medical provider!—but PrEP is overwhelmingly used by men, most of whom are gay or bisexual. Efforts are underway to get even more folks on PrEP, as only a fraction of people who may benefit actually take it. The FDA’s new rules not only muddle the message of this vital effort, but they mean the policy is not an end to the “gay blood ban” at all, because so many such men are still excluded—men who, again, are taking a proactive step to protect their health.
It’s unclear exactly how many people take PrEP, but Centers for Disease Control and Prevention data suggests at least 35 percent of gay and bisexual men considered at “high risk” of HIV do—a decision health authorities endorse. So how can we consider the FDA’s new policy an end to a ban when a large swarth of our community still cannot donate? Without more concrete, publicly available data, the FDA’s decision does not seem rooted in the most current science. The agency now runs the risk of casting a shadow on PrEP use and continuing to stigmatize gay and bisexual men—a damaging mistake that this long-awaited change in policy was meant to correct.