U.S. Food and Drug Administration (FDA) Commissioner Dr. Margaret A. Hamburg said Tuesday the agency will move to end the decades-long lifetime ban for gay men who want to donate blood.
Instead, she is recommending that men who have sex with men (MSM) be deferred from donating for one year after having sexual contact with another man. The policy effectively excludes men in monogamous same-sex relationships nationwide.
The announcement comes just weeks after an FDA advisory board met to consider replacing the lifetime ban with a one-year deferment. The deferment was recommended by the Department of Health and Human Services (HHS) Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA).
Headlines circulated earlier this month saying no change would be made. The gay activist who led the charge to end the ban predicted in an interview with Healthline earlier this week that change was coming.
“This is sort of like ‘Don’t Ask, Don’t Tell,’ in that donating blood is a way to serve your country and we’re being denied that,” said Ryan James Yezak. Yezak is a Los Angeles filmmaker who is making a documentary about his fight against the ban. “Hopefully they’re just starting to see this ban for what it is.”
Hamburg said in a statement the FDA has already begun taking steps to “implement a national blood surveillance system that will help the agency monitor the effect of a policy change and further help to ensure the continued safety of the blood supply. The FDA intends to issue a draft guidance recommending this proposed change in policy in 2015, which will also include an opportunity for public comment.”
The FDA established the no donations policy for gay men in 1983 after the government first learned that HIV could be transmitted via a blood transfusion. It was a time of fear and uncertainty. HIV tests weren’t very sophisticated. The FDA updated the donation policy again in 1992 when HIV tests became more reliable.
One-Year Deferral ‘Troubling’ to Lawmakers
Modern science has shown that not all gay men are at risk for contracting HIV. Yezak has helped push the blood donation ban into the national spotlight by organizing blood drives in cities nationwide. Straight allies donate in the place of gay men.
His drive received widespread media attention this past spring. It culminated in an FDA panel considering a recommendation to end the ban. The HHS suggested the one-year deferral instead.
But even that idea is considered offensive by many gay men. It is also unacceptable to nearly 80 lawmakers who have called on HHS Secretary Sylvia Burwell to replace the ban with a policy based on a person’s individual risk factors.
“Despite clear statements at the ACBTSA meeting that ‘HIV risk is not uniform among MSM,’ the committee nonetheless rejected a policy based on actual individual risk,” the lawmakers wrote in an open letter last week. “A one-year deferral policy, like a lifetime ban, is a categorical exclusion based solely on the sex of an individual’s sexual partner — not his actual risk of carrying … an infection.
“Furthermore, while we agree with both the ACBTSA and the FDA Blood Products Advisory Committee that a national blood safety surveillance system is a critical and overdue step to better ensure the safety of blood for all recipients, we are troubled that such a system has suddenly become a prerequisite to change the blood donation policy for MSM.”
FDA Approves Filtering Device to Protect Plasma Supply
The commissioner’s announcement comes on the coattails of the FDA’s approval of a new filtering system that can neutralize HIV in donated blood plasma.
The Intercept Blood System is made by Cerus of Concord, California. It is different from other approaches to protecting the blood and plasma supply. It doesn’t identify or test for specific threats. Instead, it shuts down all bacteria, viruses, and parasites that rely on nucleic acids to replicate.
“Platelets, plasma, and red blood cells do not require functional DNA or RNA for therapeutic efficacy,” the company stated in a news release. “The Intercept Blood System targets this basic biological difference between the therapeutic components of blood, compared to harmful pathogens and donor white blood cells. This system uses a proprietary molecule that when activated, binds to and blocks the replication of DNA and RNA, preventing nucleic acid replications and rendering the pathogen inactive.”
In its own news release, the FDA warns, “While the Intercept Blood System for plasma has been shown to be effective in reducing a broad range of viral and bacterial pathogens that may be transmitted through transfusions, there is no pathogen inactivation process that has been shown to eliminate all pathogens.”
Photo of Intercept Blood Filtering System courtesy of Cerus.