- The FDA released an updated
set of recommendationson Thursday for assessing blood donor eligibility to prevent transfusion-transmitted HIV.
- The guidelines will relax bans on men who have sex with men.
- For decades gay and bisexual men were banned from donating blood.
- In recent years they could donate blood if they abstained from sex for three months.
Men who have sex with men will soon be able to donate blood without restrictions for the first time in decades.
The Food and Drug Administration (FDA) released an updated
Under the new guidelines, all donors will answer a set of risk-based questions — relating to their recent sexual activity and whether they take medications to treat or prevent HIV infection — to determine whether they’re eligible to give blood.
The policy is a milestone for the LGBTQI+ community, specifically men who have sex with men (MSM), who for decades, have been largely unable to donate blood. In recent years the FDA
Originally the ban started at the start of the HIV outbreak in the 1980s.
“To me, in this day and age, excluding people based on their sexual preference makes no sense when we have excellent and accurate tests to screen for HIV, hepatitis (B/C), syphilis, and other infectious diseases,” Dr. Dushyantha Jayaweera, an infectious disease and HIV specialist at UHealth, the University of Miami Health System, told Healthline.
All donors, regardless of sexual orientation, sex or gender, will answer a series of questions to determine whether they’re eligible to donate blood.
Donors will be asked to share whether they have a new sexual partner, have had more than one sexual partners in the last three months, or have had anal sex within the past three months.
Those who have engaged in any of the above will not be able to give blood in order to reduce the risk of receiving donations from people who may be newly infected with HIV.
In addition, people taking medications that treat or prevent HIV, including pre-exposure prophylaxis (PrEP), will not be able to donate.
The FDA stated that though the antiretroviral drugs are safe and effective, they could impact the accuracy of blood screening tests that are used to detect HIV.
In addition, HIV cannot be transmitted sexually by people with undetectable viral levels, however, there is some risk with transfusion transmission of HIV because blood is administered intravenously and involves a large amount of blood, according to the FDA.
The FDA does not recommend that people stop taking these medications to donate blood.
Blood banks already screen for HIV with qualitative HIV antigen and antibody assays, which are nearly 100% accurate, says Jayaweera.
Health experts and LGBTQI+ advocacy groups have applauded the new guidance.
“This moves us closer to FDA policy based on science, not stigma, because HIV is not a ‘gay disease’. There is nothing inherent to sex, gender identity, or sexual orientation that makes people more likely to contract HIV—or any other illness,” Jason Cianciotto, Gay Men’s Health Crisis’s vice president of communications and policy, said in a statement.
Dr. Michelle Forcier, a clinician with FOLX Health and professor of pediatrics at Brown University, says the LGBTQIA+ community has historically been subject to hysteria and discrimination based on lack of medical research and information.
The fear and bias took root at the start of the HIV and AIDS epidemic and continues to this day, Forcier said.
“Hooray for the FDA’s ongoing commitment to using current and future evidence-based medicine to make decisions that affect all patients and to actively work to eliminate historical bias and false perceptions of risk in the LGBTQIA+ community,” Forcier said.
Still, some health experts have concerns about the limitations of the new policy.
For example, Cianciotto noted that the policy doesn’t make exceptions for people who use condoms based on data from a decade ago and questioned what evidence the FDA is using to gauge the risk of false negatives on HIV tests among those who take PrEP.
Furthermore, the FDA says the guidance is non-binding, which could potentially allow certain donation facilities from adhering to the guidance, Cianciotto said.
The FDA stated it will continue to evaluate data and technological developments to inform its eligibility recommendations.
“While it can be confusing to the public to hear about changes in recommendations, science will and should continue to rely on new and additional studies to both prove or disprove our current plans and work towards safer, more effective ways to care for patients,” Forcier says.
Finally, the new guidance will help address the nation’s blood supply shortage.
In 2022, the Red Cross declared its first-ever national blood crisis, an issue that was exacerbated by the COVID-19 pandemic.
The new guidance could expand the number of people who can donate blood in the U.S. by
“Potentially, this may increase the donor pool if they are not HIV infected or on PrEP,” says Jayaweera.
Gay and bisexual men will soon be able to donate blood without having to abstain from sex for months after decades of being banned from doing so. The Food and Drug Administration (FDA) released an updated