FDA Considers Changing Gay Blood Ban

The U.S. Food and Drug Administration is taking public comments, supported by scientific evidence, as it considers changes to its policy restricting blood donations by gay and bisexual men.

Comments to the federal agency are due by late November.

Instead of the current one-year wait after a man has sex with another man, the agency is considering a more individualized policy that focuses on risk behavior rather than sexual orientation or self-identification.

Many HIV experts agree that policy changes are overdue thanks to advances in blood safety technology and biomedical prevention.
Dr. Carlos del Rio chairs the board of the HIV Medicine Association. Photo: Courtesy of Emory University

"The HIV Medicine Association has long called for the FDA's blood donor deferral criteria to reflect the latest science and testing technology," HIVMA board chair Dr. Carlos del Rio from Emory University School of Medicine told the Bay Area Reporter. "We will be commenting in support of ensuring the safety of the nation's blood supply by revising donor screening criteria to be based on risk behaviors rather than sexual orientation."

Origin of the Blood Ban

In 1983, after it became clear that the virus that causes AIDS is transmitted through blood, experts in charge of blood supply safety instituted a policy that men who had ever had sex with another man since 1977 should indefinitely refrain from donating blood. The same lifetime deferral rule also applied to people with a history of sex work or injection drug use.

The rationale for the gay blood ban is not only that unprotected anal sex between men is an efficient route of HIV transmission - true for women who have anal sex as well - but also that the prevalence of HIV among gay men is much higher compared with other demographic groups.

Although donated blood is tested for pathogens including HIV, older tests had a longer window period before the virus or its antibodies could be detected, meaning someone who was unaware they were infected could donate blood and it could be used for transfusions before testing positive.

But now a combination of Western blot and nucleic acid tests, as currently recommended by the FDA, should detect HIV in all cases, with the exception of individuals with acute infection in the so-called "eclipse period" - lasting approximately 10 days - when HIV antibodies, the viral p24 antigen, and HIV RNA viral load are still undetectable, according to the International Association of Providers of AIDS Care.

Today, the risk of contracting HIV via a blood transfusion in the U.S. is very low - approximately 1 in 1.5 million, according to the FDA - and no transmissions of HIV, hepatitis B virus, or hepatitis C virus have been documented through U.S.-licensed blood products over the past two decades.

2015 Changes Not Enough

In December 2015 the FDA revised its policy to say that gay and bi men should wait to donate blood until 12 months after their last sexual contact with another man, and women should wait a year after having sex with a gay or bi man.

(The policy can be found online at http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM446580.pdf )

There is no exception for gay men who have been sexually abstinent in recent months, monogamous gay men with HIV-negative partners, or men who always use condoms, nor is there a distinction between anal sex and much less risky oral sex.

In addition, the meaning of "protected" sex has expanded beyond condom use. Studies have shown that people who consistently take Truvada (tenofovir/emtricitabine) as pre-exposure prophylaxis, or PrEP, reduce their risk of HIV infection by more than 90 percent. And if someone has sex with an HIV-positive partner who is on effective antiretroviral therapy and has undetectable viral load, transmission appears to be all but impossible.

Experts and advocates generally welcomed last year's change, but said it did not go far enough.

"The Department of Public Health's scientists and HIV experts have said publicly that the new rule was a step in the right direction, but the one-year abstinence policy is not supported by science," San Francisco Department of Public Health spokeswoman Rachel Kagan told the B.A.R.

The mass shooting at Pulse nightclub in Orlando on June 12 brought the issue to the fore once again, as many gay and bi men who wanted to donate blood to help injured community members could not do so under the current policy.

"It seems a shame that it apparently took the tragedy in Orlando - and the subsequent rejection of gay and bisexual men as blood donors at local blood collection centers - to motivate additional action on the blood donation policy, but we are pleased that the FDA is finally willing to entertain implementing a policy that is not blatantly discriminatory," Lambda Legal HIV policy director Scott Schoettes said in a post on the organization's website.

Dr. Jos� Zuniga, president of the International Association of Providers of AIDS Care, sent the B.A.R. a new statement drafted this week that supports removing sexual orientation from the FDA's blood donor deferral policy.

"The current 12-month deferral recommendation for men who have sex with men (MSM) is not consistent with the current epidemiology of incident HIV infections in the United States, the science of acute HIV infection, or the contemporary use of nucleic acid diagnostic technologies," according to the statement.

"From a human rights perspective, singling out MSM ignores the fact that nearly one in four new HIV infections occur among non-MSM individuals," the statement continues. "A human rights-based approach that fully appreciates the imperative to guarantee the safety of the nation's blood supply would defer blood donors, not based on their sexual orientation, but on individual risk assessments, and would limit the deferral period to the time range of the eclipse period."

In addition to gay men, the FDA's existing policy also calls for a one-year deferral for people who have received blood transfusions, had a needle-stick injury, gotten tattoos or piercings, or had gonorrhea or syphilis. Permanent deferral remains in effect for people who have ever done sex work or injected drugs, and one year for those who have had sex with people in these categories.

This type of individual risk assessment, which would involve asking potential donors a series of questions to identify those with high-risk behaviors, would become the main basis for deferral if the blanket one-year exclusion of men who have sex with men is removed.

"[The existing] policy as written means healthy gay and bisexual men who have protected sex cannot donate blood, while everyone else, regardless of their sexual practices, can," said San Francisco AIDS Foundation CEO Joe Hollendoner. "While the FDA's position on this issue has improved, SFAF believes the ban on gay and bisexual men needs to be completely lifted, as it only continues to perpetuate stigma and discrimination."

Public comment on the proposed changes to the FDA's blood donor deferral recommendations will be accepted through November 25. Comments may be submitted online at www.regulations.gov or by mail to the FDA at 5630 Fishers Lane, Room 1061, Rockville, MD, 20852, referencing docket number FDA-2016-N-1502.

For more information about the agency's call for comment, visit https://www.federalregister.gov/articles/2016/07/28/2016-17804/blood-donor-deferral-policy-for-reducing-the-risk-of-human-immunodeficiency-virus-transmission-by