On Thursday, the Food and Drug Administration relaxed restrictions on blood donors to allow some men who have sex with men to donate — a move that could increase the supply of available blood.
Since 2020, the FDA had imposed a categorical restriction on all men who have sex with men, prohibiting them from donating if they had engaged in sex in the past three months. That change — necessitated by the need for plasma, especially from individuals who had been infected with but overcame COVID-19, as a treatment for infected individuals — replaced a longer 12-month deferral period for men who have sex with men, which was imposed in 2015, supplanting a lifetime ban on gay or bisexual male donors.
In place of a categorical deferral, the FDA will instead institute a risk-based questionnaire asking the same questions of all donors, regardless of sexual orientation, biological sex, or gender identity. The questions will deal with past and present drug use, sexual behaviors, and sexual history, including whether individuals have engaged in sex for money.
Donor eligibility will be determined based on individuals’ responses to the questionnaire. Those with new or multiple sex partners in the last three months, as well as those who have engaged in anal sex, will be deferred from donating for three months. The change is intended to reduce the likelihood of donations from individuals who may have recently been infected with HIV or other bloodborne pathogens.
“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,” Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, told The New York Times.
Perhaps the biggest change for the LGBTQ community is that monogamous gay and bisexual men will be allowed to donate blood under the new guidelines. Heretofore, even if a gay or bisexual man had only engaged in sex with one partner, they would still be prohibited from donating based on the assumption that men who have sex with men are at higher risk of HIV transmission.
In adopting the revised policy, the FDA followed policies in place in other Western nations, such as Canada or the United Kingdom, and also reviewed data from other nations and a U.S. study — known as the Assessing Donor Variability and New Concepts in Eligibility (ADVANCE) Study — which indicated that switching to a risk-based assessment, rather than a categorical ban, would allow blood centers to avoid discriminating against certain groups while still protecting the blood supply.
“This shift toward individual donor assessments prioritizes the safety of America’s blood supply while treating all donors with the fairness and respect they deserve,” Kate Fry, the chief executive of America’s Blood Centers, which represents independent blood centers that provide up to 60% of the nation’s donations, told the Times. “We are proud that America is now joining many nations around the world in changing our existing policies, which have historically stigmatized certain communities. … We will continue working with our member blood centers to welcome impacted donors as quickly as possible.”
Already, Vitalant, a nonprofit blood donation company, has said that it will adopt the FDA’s revised screening rules by updating its donor history questionnaire and will begin training staff to ensure they understand who qualifies as eligible.
But LGBTQ advocates note that there are still flaws with the current donor eligibility screening criteria, particularly when it comes to those taking pro-exposure prophylaxis, or PrEP, to prevent HIV infection
Under the new donor eligibility screening criteria, individuals on PrEP — regardless of sexual orientation or gender identity — will be deferred from donating until they stop taking the medication. The FDA argues the categorical prohibition is needed to avoid “false-negative” result, in which a person with HIV or another disease may be infected, but blood tests do not yet indicate the presence of antibodies for a particular pathogen.
“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 said in a news release.
But that prohibition has been criticized by some LGBTQ advocates, who say it unfairly stigmatizes individuals on PrEP based on their presumed — and not actual — promiscuity, as PrEP is generally recommended for sexually active people who are considered to be at higher risk of HIV transmission. Therefore, even as LGBTQ organizations have praised the elimination of the categorical ban on men who have sex with men, they have also noted that the prohibition on PrEP users and those in non-monogamous relationships will discourage some gay and bi men from donating.
“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,” the LGBTQ media advocacy group GLAAD said in a statement.
Kelley Robinson, the president of the Human Rights Campaign, echoed those same critiques of the revised guidelines.
“This new policy ends a decades-old ban rooted in discrimination and bias. We applaud the administration for listening to the community and taking action. While that’s a victory, real obstacles are going to remain, especially for gay, bisexual and other same-gender loving men. More can and must be done so that people taking PrEP can donate as well,” Robinson said in a statement.
Public health experts are hopeful that the end of the categorical ban will increase the overall supply of blood and blood products. According to data from America’s Blood Centers, just three percent of the U.S. population donates blood each year. By eliminating some of the restrictions historically imposed on gay and bisexual men, the FDA is expanding the pool of available donors. A 2014 study by the Williams Institute, a think tank focusing on LGBTQ policy at the UCLA School of Law, estimated that lifting a categorical ban on gay and bisexual men would free up an estimated 360,000 additional donors, providing enough pints of blood to help save the lives of more than a million people.
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