Editorial: FDA misses with blood ban revisions

  • by BAR Editorial Board
  • Wednesday February 1, 2023
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The federal Food and Drug Administration has issued draft guidance that would allow some gay and bi men to donate blood, but not if they're on PrEP. Photo: Courtesy FDA
The federal Food and Drug Administration has issued draft guidance that would allow some gay and bi men to donate blood, but not if they're on PrEP. Photo: Courtesy FDA

The news that the federal Food and Drug Administration would ease guidelines on blood donations by gay and bisexual men at first blush seems like a positive development — and in a small way it is. After facing criticism for years over its hardline preventing of gay and bi men who have had sex with men from donating blood — even as new technology made it easier and more reliable to test for HIV — the FDA last week issued draft guidance that would allow gay and bisexual men in sexually monogamous relationships to donate blood.

The problem with this new draft proposal is a huge caveat — these men cannot donate blood if they are on PrEP, the HIV prevention regimen that is very successful when taken as prescribed. They must go off oral PrEP for three months if they want to donate. That, as gay state Senator Scott Wiener (D-San Francisco) wrote in a tweet, essentially means that eligible gay and bi men will be forced to go off an effective HIV prevention method if they want to donate blood, which could, of course, increase their risk for HIV.

The New York Times reported that Dr. Peter Marks, director of the FDA's biologics center, stated that the rationale for the PrEP restriction is because blood centers may not be able to detect HIV infection in donors taking the drugs. The news for those taking injectable PrEP is even more restrictive — they will not be able to donate for two years after their last dose. So, while it is progress that the FDA is removing sexual orientation as a means of restricting blood donors, and that all donors will be screened for HIV risk in the same way, a large number of gay and bi men would still be unable to donate.

The FDA and blood centers have a long discriminatory history when it comes to gay and bi men wanting to donate blood, though in recent years there has been incremental progress. The initial rule, formulated in 1983 during the early days of the AIDS epidemic, was a lifetime ban on any man who had sex with another man after 1977. This was changed in 2016 to a 12-month deferral, and again in 2020 to a three-month deferral. As we reported last week, technology to screen blood samples for HIV, the virus that causes AIDS, has rendered a blanket ban obsolete, according to the American Medical Association. LGBTQ rights groups have long argued that any ban should be based on reported behaviors, not sexual orientation. With the draft guidance, the FDA is moving in that direction.

But HIV/AIDS continues to be a chronic disease with no known cure. There is no hope for a vaccine on the horizon — we reported last month that a large trial was halted when it failed to prevent infection. A companion trial was stopped in 2021 due to similar issues. That makes prevention tools like PrEP even more crucial. Since PrEP's availability in 2012, more and more men who have sex with men are taking it, but as we've long reported, disparities remain, especially in communities of color. It's important that local health departments and community clinics get more men on PrEP to prevent HIV.

The Human Rights Campaign also bemoaned the PrEP exclusion in the draft FDA guidance. "In the meantime, it is absolutely essential that those who are currently receiving PrEP treatments continue to remain with their medication. We will soon be a step closer to ending the stigma that has existed for decades as a result of the harmful blood donation ban, and in the process, we will be able to ensure that the blood supply remains protected. Now the work must continue to refine this policy," stated HRC President Kelley Robinson.

All of this comes as the nation's blood supply remains critically low in many areas of the country. The Times reported that America's Blood Centers, an organization that represents blood donation companies, stated that the COVID pandemic disrupted school- and work-based blood drives that were the "backbones of blood donation." About a quarter of all blood transfusions are needed for cancer patients, the group noted, and those are needed about every two seconds in the U.S., the paper reported.

The FDA's draft proposal does not mean changes will happen anytime soon. First, there will be a 60-day public comment period. After that, the FDA is expected to review and adjust its guidance. Then the various blood centers will need to update their donor history questionnaires and their computer systems as well as train staff, the Times noted.

We're glad the FDA is finally moving in the right direction when it comes to gay and bi blood donors. But the agency is still discriminating against them if they aren't in a monogamous relationship where both men are HIV-negative and not on PrEP.

Until there is real change so that more gay and bi men can donate blood, which likely would entail technological improvements in detecting HIV in donors taking PrEP, we are mostly unimpressed with the latest draft proposal.

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