FDA May Lift Lifetime Ban on Gay and Bisexual Men Donating Blood

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In a move that many have been advocating for decades, the Food and Drug Administration (FDA) is considering lifting the lifetime ban on gay and bisexual men donating blood. While the change has been expected since last December, the Obama administration recently offered an official recommendation ending the ban, and after a 60-day period (ending July 14th) reserved for public commentary, the FDA will finally come to a decision.

What is the ban about?

Men who have sex with men, even just once, have been banned from giving blood since 1985, during the early days of the AIDS epidemic. When the restrictions were written, HIV testing was slower and less precise than current tests, which are far more sophisticated and can detect the virus in the blood in as little as nine days after infection.

Currently, all donors must undergo an extensive screening process in which they are informed about potential risks and are required to answer questions about factors that may compromise the safety of their donation. The FDA also reviews and approves all test kits used to detect infectious diseases, and each donation is required to undergo a series of tests for viruses including HIV, hepatitis B and C, and syphilis. To further enforce restrictions placed on certain high-risk groups, including men who have sex with men, blood collection establishments are required to keep current lists of deferred donors to ensure they do not collect blood from them.

What might change?

If the ban is lifted, the lifetime restriction will be abolished, but men will still have to wait at least one year after having sex with another man before giving blood. The revised waiting period would be more in line with the rules imposed on other groups that engage in what is considered “risky” sexual behavior who also must wait at least one year after participating in the high-risk act. These groups include heterosexual individuals who have sex with HIV-positive partners, intravenous drug users, and sex workers. Travelers who have visited certain parts of Africa are also subject to a one-year waiting period, due to their increased risk of exposure to the virus.

Although the step down to a one-year ban would be a significant change, many in the medical community feel it still doesn’t go far enough. “The FDA has definitely taken a step in the right direction, but they can go further, as I expect they soon will,” says One Medical’s Malcolm Thaler, MD. “We have become so adept at screening for and early detection of diseases such as HIV and hepatitis C that are highly prevalent among men who have sex with men that having them wait a full year seems to make little sense. I understand the caution, but I suspect the barriers to blood donation will soon drop even more, and justifiably so.”

What is the controversy?

The ban has been met with opposition from both the medical and LGBT communities since its implementation. Critics in both camps believe the ban is discriminatory and have advocated for change over the years. Those in favor of lifting the ban have argued that because the blood donations are thoroughly tested to rule out viruses including HIV, Hepatitis B, and Hepatitis C, the policy against gay and bisexual donors is rooted in stereotypes and homophobia. The FDA rigorously regulates how blood donations are collected and how blood is transfused, and said it would ensure the supply remained safe by implementing a blood surveillance system.

“The current testing paradigms will protect the blood supply in anyone who engaged in risky behavior in the past, but not in the prior year,” says One Medical’s Bruce Olmscheid, MD.

Last year, a panel of independent experts concluded that a yearlong waiting period would not endanger the safety of the nation’s donated blood supply. The American Medical Association also voted to oppose the ban, saying that it is “discriminatory and not based on sound science.” The three main suppliers of the nation’s blood supply—The American Red Cross, American Association of Blood Banks, and America’s Blood Centers—have all opposed the ban for years as well.

“This change in policy makes sense clinically,” Olmscheid says. “The label we attach to our sexuality does not put us at increased risk of being HIV-positive. The behavior may be associated with increased risk. Men who identify as gay, but do not actually engage in sex with other men, are not at increased risk of having HIV and should not continue to be eliminated from being able to donate blood.”

Proponents of the ban, however, claim that the possibility of false negative test results can endanger the blood supply and men who have sex with men are disproportionately affected by HIV. In 2011, men who have sex with men made up only seven percent of the US male population, but accounted for 57 percent of people living with HIV.

What’s next?

Once the FDA considers public commentary, the organization will revisit its policy and later issue final rules. Many in the LGBT community and medical community are hoping for a change occurs soon to rectify what they feel has been an unfair and inaccurate ban. To learn more about the FDA’s longstanding stance on men who have sex with men and blood donation, read the agency’s questions and answers page. And to contact the FDA to voice your opinion, call 800-835-4709 or email ocod@fda.hhs.gov before the July 14th deadline.

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The One Medical blog is published by One Medical, an innovative primary care practice with offices in Boston, Chicago, Los Angeles, New York, Phoenix, the San Francisco Bay Area, Seattle, and Washington, DC.

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