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Gay & Bisexual Men Now Eligible to Donate Blood Under New FDA Policies

Gay & Bisexual Men Now Eligible to Donate Blood Under New FDA Policies

Man giving blood.

The agency has moved toward risk-based assessments as opposed to discriminatory bans based on gender or sexual orientation.

U.S. Food and Drug Administration officials have issued new guidelines to make blood donation accessible to queer men. No matter their gender or sexual orientation, all potential donors will be asked the same questions in a move that ends the previous screening based on sexual orientation, which many considered discriminatory. Men in monogamous relationships are no longer required to abstain from sex to donate

Several years ago, an FDA reexamination led to the lifting of a lifetime ban on blood donations for gay and bisexual men. A more recent policy recommended a three-month wait for sexual activity before blood donation for men who have sex with men.

There will no longer be gender-specific deferrals or screening questions related to sex with men or sex with women. This means the United States joins the United Kingdom and Canada in implementing risk-based regulations.

A donor who reports having had anal sex with a new partner or reports having more than one sexual partner in the past three months and has had anal sex in the past three months will be deferred.

Additionally, under this final recommendation, those taking medications to prevent or treat HIV infection will be deferred — including antiretroviral therapy (ART), pree-xposure prophylaxis (PrEP), and post-exposure prophylaxis (PEP).

“We’ve had a progression over the past seven, eight years going from what was an indefinite deferral of men who had sex [[with] men from donating blood to a 12-month deferral, which started in 2015, to a three-month deferral which took effect in 2020,” Director of the Food and Drug Administration’s Center for Biologics Evaluation and Research Dr. Peter Marks tells The Advocate. “Each of those steps was based on the science that we had available, the introduction of highly sensitive tests, as well as the use of donor screening questionnaires.”

As a result of available science, he says, the FDA sought to move toward an individual risk assessment policy, which is the basis for the updated guidelines.

Although today’s sensitive instruments are exceptional at keeping the blood supply safe, he says, it’s necessary to add a screening layer when collecting blood for donation.

However, detecting HIV in recently infected people is one of the challenges for the instruments.

“There is a period with our current testing, it’s about 10 days after infection, where our current tests are not able to tell whether someone has been infected,” he says. “It’s just they’re not sensitive enough to be able to pick up the virus. And because of that, we need to have an additional layer of safety on top of that by asking people whether they have done anything in that recent past that could put them at risk for having become infected.”

He adds, “So the questions that are being asked now are ones to help ascertain that, and they help close that loop in our current testing.”

The FDA may be able to reduce restrictions in the future as testing improves and more data and experience are gathered, Marks says. Blood donation is not possible for people who take medication for HIV prevention or who take PrEP even though PrEP helps prevent the person taking it from acquiring HIV.

“We really want people to keep taking their PrEP,” he says. PrEP does an extremely good job at making sure a person doesn’t acquire HIV through sex, he explains, because the amount of blood exchanged “is measured in fractions of teaspoons.”

Blood transfusions, however, require a significant amount more of blood.

“The issue is that when you’re talking about something that’s a thousand times more in volume, that potentially means that if there’s a little virus there, it could come along,” he says. “The other problem that goes along with PrEP is that, because it keeps down replication of the virus, in that larger volume, there could be a small amount of the virus, and our current tests won’t be able to detect it.”

Marks says that as science works to develop better tests, the FDA will continue to work on having better algorithms but that for now, to ensure that the blood supply remains safe, deferral for those on PrEP is necessary.

“We’re committed to keeping our policies as up-to-date as we can and science-driven so that we can [allow] as many people to donate as we can,” he says.

In the case of donors who choose to donate but are prevented from doing so because of recent anal sexual activity, Marks argues that the reason is based on human anatomy.

Marks explains that oral sex transmission is extremely unlikely.

“It turns out the chance of transmitting HIV through penile-vaginal sex is not as small as oral sex, but it’s not a huge amount greater because the chance of breaking down the mucosal barriers, in other words, sharing blood with one another, is relatively low,” he says. “The problem simply has to do with the fact that when one has anal sex, there is the ripping of membranes sometimes, and there’s a much higher chance of sharing blood there.”

He adds, “That’s why the risk goes with anal sex, whether you’re a man or a woman.”

As Marks points out, the policy change results from a partnership with the LGBTQ+ community.

“It’s really important that you know that this was a wonderful partnership where LGBTQ+ organizations worked together with the blood collection community and with community health centers,” he says.

According to Marks, there may be a few weeks or months until all blood collectors implement the new policy.

“People won’t be able to go out tomorrow and donate blood because it’s going to take a few weeks to get the appropriate changes made to computer systems and [get] the appropriate training done because we want to make sure when people show up, they get welcomed the way they should,” he says.

Some collectors may take a few weeks to be up and running, while more complex systems may take a few months.

“I think the blood donor centers have even tried to really move as fast as they can here because they realize how important this is to the community,” Marks says.

Gay Democratic Rep. Mark Pocan of Wisconsin, who is the chair of the Equality Caucus in Congress, said that it was about time that the FDA's policies were changed.

“For far too long, the federal government used outdated and unscientific fears to determine who can and cannot give blood. FDA’s final recommendation on blood donation eligibility is an important step forward in creating guidance that screens all people for blood donations based on the science of virus transmission rather than a person’s sexuality or how they identify,” Pocan said in a statement. "This recommendation aligns with the LGBTQI+ community’s long-term request for individualized risk-based assessments. My colleagues and I commend these final recommendations and urge the FDA to continue to invest in improvements in testing and pathogen reduction technologies so they can remove further barriers that may still prevent some LGBTQI+ people from donating blood.”

The LGBTQ+ rights group GLAAD welcomed the news but said the deferral for those taking PrEP contributed to "unnecessary stigma."

"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 organization said in a release. "While today's guidance is an important step in the right direction, the deferral period for individuals on PrEP, an FDA-approved drug proven to prevent HIV acquisition, continues to erect barriers to LGBTQ blood donors. 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."

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