FDA relaxes blood donation eligibility for gay, bisexual men. Experts say they’re ‘delighted’
For decades, gay and bisexual men have not been able to donate blood, a 40-year-old policy enacted by the Food and Drug Administration that has been criticized as discriminatory.
In the decades since the FDA has slowly relaxed restrictions for men who have sex with men, but some still argue its exclusions are unfair. For example, the FDA allowed gay and bisexual men to donate blood if they refrain from having sex for a three-month period.
But now, the FDA has made a change that is considered to be a significant milestone for donating blood since the policies were first enacted in the early days of the AIDS epidemic.
In its update, the FDA lifted the abstinence requirement for men who have sex with men as long as they are in a monogamous relationship. It also recommends that blood donors be asked a series of "individual risk-based questions" that will be the same for every blood donor, regardless of their sexual orientation, gender or sex.
A lot of research and study went into this change by the FDA, and one of the partners in that research is Vitalant, the leading blood donation agency in Northern California. The non-profit partnered with two other agencies to pilot a study which assessed the FDA’s blood donor deferral policy for men who have sex with men.
“We ultimately showed where the risk was and where it was not for HIV, including the use of blood safety,” said Dr. Chris Gresens, the Medical and Laboratory Director for Vitalant. “And we saw that the risk was not with monogamous individuals who were in long-term committed relationships.”
CapRadio’s Vicki Gonzalez sat down with Gresens, who provided more details about the FDA’s policy change and explained how research helped the agency come to this decision.
This interview has been edited for length and clarity.
On the importance of needing a greater pool of blood donors in Sacramento
The need for blood continues to be great for a number of reasons. Patients, more than ever, need blood for regular day-to-day needs: trauma, burns, and other types of accidents and problems. And then [there is] pent-up demand. Over the last couple of years, more and more patients who postponed their treatments during the COVID pandemic are catching up, and that’s a good thing.
But the challenge is it means more of a strain on our resources, including blood. Fewer people, in general, are coming up and bearing their arms for blood donations, so we’re delighted by the news.
On why the FDA originally banned blood donations from men who have sex with men
Going back to the late 70s, early 80s … HIV, the virus that causes AIDS, came into prominence. At the time, I was an undergraduate and a young medical student, and I recall a lot of good people were trying to figure out how we could prevent the spread of this disease as well as treat appropriate patients who had it.
One of the prevention methods at the time that was most important was safeguarding the blood supply. To put this into perspective, of the 20,000 people living with hemophilia at the time who received infusions from blood donations, half of them — 10,000 — came down with HIV, and an even greater percentage with hepatitis C virus.
So this was not a trivial issue, as you can imagine. Lives were being infected and in great numbers. Around that time, screening [blood donors] came into play. Unfortunately, as a result of not having enough tools at our disposal, the screening was done with a very broad brush.
We as an industry decided to exclude people who were most at risk for HIV, which at the time and to some extent [today] still remains men who have sex with men. Over the years, we’ve evolved from this. I think it took longer than was probably needed.
By the mid-2010s, we [as an industry] had moved towards a 12-month parole for men who have sex with other men, which still wasn’t an idea by any means because it still denied too many good people from the LGBTQ+ community the chance to donate and to participate in this.
By 2020, we had reduced it to three months from the last sexual contact. Now finally, we’re at a point based upon the evidence where we're asking the same question of everybody, whether male, female, or transgender. We’re getting to individual risk-based assessments [of donors].
On how the new risk-based assessment works
For me, for you, for a transgender community member, the same question will be asked, “have you had sex in the last three mores with more than one sexual partner or a new sexual partner?” If the answer is no, for instance, for people in committed monogamous relationships, that’s it — [we] move on.
If the answer is yes, then there is a follow-up question. Again, this applies to everyone, “was the practice of anal sex involved in that sexual relationship?” And if the answer is yes, at this point, a three-month deferral will still apply. It’s still not perfect as far as inclusivity, but it’s being used across the board, whoever the individual is, including heterosexual couples who have had anal sex.
So we’re reaching a point of greater inclusivity and equity and hoping over time to take this even further.
On how Vitalant’s research helped clear the pathway for this FDA update
With our advanced study that was spearheaded by colleagues in our San Francisco-based research lab, we worked with a very large group of gay men — over 1,500 individuals — with whom we discussed questions related to HIV risk and also for whom we did HIV and other blood testing.
We ultimately showed where the risk was and where it was not for HIV, including the use of blood safety. And we saw that the risk was not with monogamous individuals who were in long-term committed relationships.
For somebody whose last sexual contact in a non-monogamous situation involving anal sex was more than three months ago, we saw that while there was a risk there for HIV, our tests were capable of detecting that infection, so we can prevent blood coming from those people from getting into a patient. So those details were tremendously helpful.
Finally, I’ll share [what we’ve] learned from our brothers and sisters in other parts of the world … Canada did this just over a year ago … and we’ve seen from their experiences that there are greater numbers of donors who come in and that risk is not significantly increased.