Comment period wraps up for FDA proposal on easing blood donation rules for gay and bisexual men

OMAHA, Neb. (WOWT) - The 60-day comment period is wrapping up for the FDA’s proposed new guidance for donating blood.

Essentially, these new rules would make it easier for gay and bisexual men to donate blood.

Restrictions on blood donations from gay and bisexual men stem from the onset of the HIV and AIDS crisis in the early 80′s.

“There’s been so much change since then, so much that we’ve come to understand about the virus that it’s time to change,” says Tommy Dennis, the Outreach Manager for the Nebraska AIDS Project.

Over the decades, testing for HIV has massively improved.

“Early on there was only an antibody test… and now it’s so improved that there’s a nucleic acid test for the direct detection of viral RNA in the blood,” says Dr. Nancy Van Buren, Medical Director of Innovative Blood Resources. “So it is a very narrow window period where someone could potentially be exposed to infection and not be detected in blood.”

In 2015, the FDA dropped the lifetime ban for gay and bisexual men and replaced it with a one-year deferral.

The current guidelines, enacted in 2020, state that gay and bisexual men are allowed to donate blood if they haven’t had sex with another man for three months.

But the question is, has this been fair?

“Going back to the UK, they actually had an acronym for fair because they realized it wasn’t fair just to have an indefinite deferral for gay and bisexual men that were in very committed, monogamous relationships. They would be just as safe as anyone else who would be eligible. So they realized that they needed to take a gender-neutral approach to assess sexual behavior risk. In this country, it’s been talked about for a long time, yes we need to asses that but from the FDA’s point of view, because they have to ensure safety, they had to do it as far as the science would support,” says Van Buren. “So there was a very large study that took place over the last several years and closed as of just last September. All of that data went to the FDA for review, to say does the scientific DNA evidence support a gender-neutral approach? They determined that yes, that there is enough scientific evidence and it’s strongly supported by what we’re seeing in other countries and what they’re doing now too.”

The new proposed rules would allow anyone to give blood, regardless of gender or sexual orientation, as long as they haven’t engaged in certain sexual behaviors in the span of three months.

“For so long we have limited ourselves and to that end it’s been at the cost of other people’s lives. You even look at the statistics around blood donation right now and there’s been shortages of folks who are donating blood,” says Dennis.

In a questionnaire, it would ask potential donors if they’ve had any new or multiple sexual partners in the last three months.

“If that’s the case, then and only then, they would ask have you had anal sex in the last three months. The reason for that anal sex deferral is because there’s a slightly greater risk for blood exposure if there’s anal sex, which would put a person at higher risk… if the answer is yes then they would be deferred for three months,” says Van Buren.

Anyone taking oral medication to help prevent HIV, such as PrEP, would be subject to a three-month deferral period. Anyone taking injectable PrEP would be deferred for two years from their last injection. Anyone who currently has HIV, would still be asked *not* to donate.

Dennis says this is a step in the right direction, after years of stigma and discrimination.

“The fight is never-ending. There’s still negative stigma that exists. But it’s going to be actions like this by the FDA finally relaxing their standards around blood donation that’s going to help push us a little more forward.”

The FDA will now collate all the questions and comments.

Dr. Van Buren expects the final guidance to be issued by around this May.

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