FDA policy allowing more gay and bisexual men to donate blood goes into effect.
In a victory for LGBTQ rights, a broad swath of the U.S. population of gay and bisexual men on Monday became newly able donate blood, thanks to the implementation by the American Red Cross of a landmark recent change in Food and Drug Administration policy.
The policy, put on the books by the FDA in May, newly permits donations from men in monogamous relationships with other men, as well as those who have not recently engaged in anal sex.
Gay activists and medical groups had long fought for this policy revision, especially in the face of blood shortage crises. They argued that the previous, more restrictive policies, while explicitly in place to protect the blood supply from HIV, were nevertheless discriminatory and not based on sound science given advances in testing technology.
David Stacy, vice president of government affairs at the Human Rights Campaign, the nation’s largest LGBTQ advocacy organization, called the new policy “a long-awaited step forward” that “marks the end to a decades-old ban rooted in discrimination and bias.”
In 1985, four years into the AIDS crisis, the FDA established a lifetime blood donation ban on men who had ever had sex with another man since 1977. In 2015, the agency adjusted this policy to defer men’s donation eligibility for 12 months after their last sexual encounter with a man. During the early days of the Covid pandemic, this deferral period was reduced to three months.
The FDA maintained that these policies were necessary to protect the blood supply.
All blood donations are screened for HIV and hepatitis B and C. The screening questions are meant to weed out potential donors who might have very recently contracted any of these viruses and whose blood might therefore test false negative. The test for HIV in particular, while highly precise, does not detect the virus until about 10 to 33 days after infection.
The Centers for Disease Control and Prevention estimated in May that 70% of new HIV transmissions occur among men who have sex with men, who comprise about 2% of the adult population.
In January, the FDA first proposed a screening system that, in the explicit name of gender inclusivity, dispenses with questions about the sex of potential donors’ partners in favor of focusing on sexual acts. Following a period for public comments, it decided in May to adopt the new policy.
The previous screening protocols have apparently been successful, with the FDA reporting no transmissions of HIV or hepatitis B or C from any U.S.-licensed blood transfusions within the past three decades.
Previously, FDA policy excluded from donation anyone who reported that within the past three months they had had sex with someone living with HIV; or if the potential donor is a man reporting sex with another man during this period; or a woman reporting sex with a man with a recent history of sex with another man.
The blanket policy rejecting people reporting recent sex with HIV-positive partners remains in place. This is despite scientific consensus that people who maintain an undetectable viral load thanks to antiretroviral treatment of the virus cannot transmit it through sex. A new study published in The Lancet on Aug. 5 further found that those who have a detectable but relatively low viral load, of 1,000 or below, still have an “almost zero” chance of transmitting the virus.
The new FDA screening policy forbids donations from anyone, regardless of their sex, who reports that within the past three months they have had a new sexual partner or multiple partners and who during that time have had anal sex.
Consequently, a population of heterosexuals who are not in monogamous long-term relationships are now newly ineligible to donate blood. A 2020 study estimated that at least one-third of heterosexuals engage in anal sex.
Dr. Jesse Ehrenfeld, the new head of the American Medical Association, who is the first openly gay person to hold that post, characterized the former FDA blood screening policy as based on “outdated categorical restrictions."
“This policy change will ensure that blood donation criteria are applied more equitably across all segments of our population, including the LGBTQ+ community,” he said.
The authors of a 2014 CDC study estimated that people having receptive anal intercourse without a condom with a partner who has untreated HIV are 10 to 20 times more likely to contract the virus than a woman having vaginal sex or a male having insertive anal sex.
But gay and bi men are far more likely to be exposed to HIV in the first place. Dr. Patrick Sullivan, a professor of epidemiology at Emory University, said he roughly estimates that men who have sex with men acquire HIV at a rate 400 times greater than heterosexual men.
Britain and Canada preceded the United States in adopting comparable behavioral-based screening systems, which to date have proved successful at maintaining the blood supply’s safety. A recent analysis found that the Canadian policy has newly rejected just 0.08% of potential donors.
The new U.S. screening policy is based on a pilot study of 1,566 gay and bisexual men, which first posted results in a preprint, non-peer-reviewed paper in April. The study authors concluded that the new screening questions were feasible.
The policy also forbids people from donating blood if they have taken the medications Truvada or Descovy for HIV prevention—a protocol known as PrEP— within the past three months. Those who have taken the long-acting injectable form of PrEP, Apretude, are excluded for 12 months since their last injection.
Some in the LGBTQ community have protested against these PrEP-based exclusions as evidence that the FDA maintains a discriminatory posture toward gay and bisexual men. In May, California state Sen. Scott Wiener, a Democrat and an openly gay man who went public about taking PrEP in 2014, characterized this policy as “truly irrational”, given PrEP is highly effective at preventing HIV acquisition.
According to the FDA, the PrEP-based deferral policy is grounded in research suggesting that people who have recently taken such preventive medication and who nevertheless contract HIV might be more likely to test false negative for the virus. In rare cases, people taking PrEP have experienced breakthrough cases of HIV, typically because they were exposed to rare drug-resistant strains of the virus. People might also contract the virus during a period when they have stopped taking the medication or are not taking it routinely, only to return to taking it again without realizing they have contracted the virus.
There are an estimated 3.8 million HIV-negative men who have sex with men in the U.S. According to CDC data, PrEP was used for at least part of 2022 by a minimum of 318,400 people, a population overwhelmingly composed of gay and bisexual men
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