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FDA Taking Public Comment on Potential Changes to Gay Blood Donation Policy

Through late November the U.S. Food and Drug Administration (FDA) is currently accepting public comments, supported by scientific evidence, as it considers changes to its policy restricting blood donations by gay and bisexual men. Instead of the current 1-year waiting period 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.

"The HIV Medicine Association has long called for the FDA's blood donor deferral criteria to reflect the latest science and testing technology," said HIVMA board chair Carlos del Rio from Emory University School of Medicine. "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."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 than it is in other demographic groups.

Origin of the Blood Ban

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 (IAPAC).

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 issued Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products, stating 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.

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) for pre-exposure prophylaxis, or PrEP, reduce their risk of HIV infection by more than 90%. 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 mass shooting at Pulse nightclub in Orlando, Florida, 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.

The International Association of Providers of AIDS Care drafted a new statement 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 1 in 4 new HIV infections occur among non-MSM individuals," the IAPAC 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 1-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 1 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 1-year exclusion of men who have sex with men is removed.

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

9/2/16

Sources

Food and Drug Administration. Blood Donor Deferral Policy for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Establishment of a Public Docket; Request for Comments. Federal Register. July 28, 2016.

International Association of Providers of AIDS Care. IAPAC Proposes Significant Revision to FDA Ban on MSM Blood Donations. August 30, 2016.

S Schoettes. The FDA (Finally Opens to Door to a More Enlightened Blood Donation Policy. Lambda Legal. August 2, 2016.