The United States Food and Drug Administration announced Thursday that it finalized new blood donation guidance will allow gay and bisexual men in sexually monogamous relationships to donate blood — but not if they are on PrEP, in which case they have to wait three months from their last dose.
The Bay Area Reporter reported that the FDA was considering the new guidance in January.
The agency's hardline ban on men who have sex with men from donating blood has crumbled in recent years. The initial rule, promulgated in 1983 during the early days of the AIDS epidemic, was a lifetime ban on any man who had sex with another man after 1977. This was changed in 2016 to a 12-month deferral, and again in 2020 to a three-month deferral.
Technology to screen blood samples for HIV, the virus that causes AIDS, has rendered a blanket ban obsolete, according to the American Medical Association. LGBTQ rights groups have long argued that any ban should be based on reported behaviors, not sexual orientation.
People who are HIV-negative but taking pre-exposure prophylaxis (PrEP) will still be banned from donating blood under the draft guidance, however, because the medications used for PrEP are among those that can't be taken by blood donors.
"Although HIV is not transmitted sexually by individuals with undetectable viral levels, this does not apply to transfusion transmission of HIV because a blood transfusion is administered intravenously, and a transfusion involves a large volume of blood compared to exposure with sexual contact," the FDA stated in a news release.
PrEP, or pre-exposure prophylaxis, refers to the use of antiviral drugs to prevent people exposed to the HIV from becoming infected. The pill Truvada was first approved for PrEP use in 2012 by the FDA; since then the agency has also approved the pill Descovy for some groups, and the drug Apretude as an injectable treatment. According to federal Centers for Disease Control and Prevention statistics, only 25% of the approximately 1.2 million Americans who could benefit from PrEP had prescriptions in 2020.
Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, stated in the same release that the new policies are based in science and that it will work with the blood donation industry to implement them.
"The FDA has worked diligently to evaluate our policies and ensure we had the scientific evidence to support individual risk assessment for donor eligibility while maintaining appropriate safeguards to protect recipients of blood products," Marks stated. "The implementation of these recommendations will represent a significant milestone for the agency and the LGBTQI+ community."
Mixed reactions
The decision prompted mixed reactions in the LGBTQ community.
Sarah Kate Ellis, a lesbian who is president and CEO of GLAAD, called it "an important step in the right direction" while criticizing the decision to exclude people on PrEP.
"The FDA's decision to follow science and issue new recommendations for all Americans, regardless of sexual orientation, who selflessly donate blood to help save lives, signals the beginning of the end of a dark and discriminatory past rooted in fear and homophobia," Ellis stated.
"The deferral period for individuals on PrEP, an FDA-approved drug proven to prevent HIV acquisition, continues to erect barriers to LGBTQ blood donors," she added. "Placing potential blood donors taking PrEP in a separate line from every other donor adds unnecessary stigma. The bias embedded into this policy may, in fact, cost lives. GLAAD urges the FDA to continue to prioritize science over stigma and treat all donors and all blood equally."
Kelley Robinson, president of the Human Rights Campaign, called it "a victory."
"These updated guidelines are a real step forward, ensuring that donors are not evaluated simply for being part of the LGBTQ+ community," Robinson, a queer woman, stated. "Science advanced, making it possible for FDA to modernize its guidelines with full confidence in the safety of the blood supply. We're calling on the federal government to make further investments in research and technology to open opportunities for all Americans to become blood donors."
Gay state Senator Scott Wiener (D-San Francisco) was far less sanguine.
"FDA is again falsely announcing it's ending the ban on gay men donating blood. The criteria FDA uses to exclude donors — especially the irrational exclusion of people on PrEP (which essentially eliminates HIV risk) — effectively exclude a huge # of gay men @ super low HIV risk," Wiener, who takes PrEP, stated in a tweet thread "The PrEP exclusion is truly irrational. If you take PrEP, your HIV risk is all but zero — much lower than if you don't take PrEP. Yet you can only give if you're not taking PrEP (i.e., higher HIV risk). The FDA PrEP exclusion is a classic case of missing the forest for the trees."
Benjamin Ryan, a gay editor-at-large with Poz magazine, disagreed entirely.
"Some object to the FDA forbidding people who've recently taken PrEP from donating blood. But research has found that people who contract HIV (due to uneven adherence or a drug resistant strain) during a period when they are taking PrEP may have a false negative test result," he tweeted. "The new FDA blood donation policy will probably not generate that much new blood supply from gay men. Meanwhile, the policy newly excludes heterosexuals who have had recent new anal sex partners, which could lead to less blood donation from straights."
Updated, 5/12/23: This article has been updated to include that state Senator Scott Wiener takes PrEP.
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