On July 14, the U.S. Food and Drug Administration (FDA) closed its period for members of the public to weigh in on its proposal to change the current lifetime ban on men who have sex with men. That proposal would change the lifetime deferral to a one-year deferral period from the time of the last sexual encounter before such men are allowed to donate blood, tissue or other biological products such as bone marrow.
Under the current policy, first adopted in 1983, men who have engaged in sex with another man — even once — since 1977 have been “indefinitely deferred” from donating blood, even if decades have passed since the sexual encounter, for fear of HIV transmission. But some LGBT rights groups, and many within the medical community, say that what essentially constitutes a lifetime ban on some groups, including gay and bisexual men, is medically and scientifically unwarranted. They argue the lifetime ban should be changed to a much shorter deferral period, given the advances in technology that can be used to detect if HIV antibodies or antigens are present in the bloodstream.
“We appreciate the fact that the FDA is willing to take another look at this,” says Daniel Bruner, the senior director of policy at Whitman-Walker Health, which specializes in HIV treatment and care. “We appreciate that they want to reduce the deferral period, but we don’t think they’ve gone nearly far enough. Once you donate blood, of course, the donated blood is tested for HIV right away. So the only concern would be the ‘window period,’ the period of time between exposure to the virus and when today’s reliable tests would find a positive result.”
Under draft guidance issued in May, the FDA is recommending the lifetime ban be changed to a one-year deferral period after the last sexual encounter. This proposed timeline is consistent with recommendations previously made by the American Red Cross, America’s Blood Centers, and the American Association of Blood Banks dating back to 2006, as well as by the federal Advisory Committee on Blood and Tissue Safety Availability, which advises the U.S. Secretary of the Department of Health and Human Services.
The one-year deferral period would also apply to other groups besides MSM, including females who have had sex with gay or bisexual men; anyone who has been treated for gonorrhea or syphilis; anyone who has received a blood transfusion in the past year; and anyone who has had any sexual contact with a person who is HIV-positive or has ever engaged in risky behaviors such as exchanging sex for money or drugs, or engaged in non-prescription drug use.
Indefinite referrals would remain in place for HIV-positive people, sex workers and non-prescription IV drug users.
The open public comment period regarding the proposed deferral period attracted 48 different comments, with many coming from members of the medical or scientific community, others from pro-LGBT organizations, and others from social conservatives opposed to changing the current policy. In all cases, commenters pleaded with the FDA to make its decision based on science, not on public pressure.
In its own comments, Whitman-Walker Health suggested that the FDA adopt a much shorter deferral period for MSM, women who have had sex with MSM, former sex workers and former IV drug users. Whitman-Walker also suggested that the FDA stop discriminating against transgender people and treat them according to the guidelines followed for cisgender individuals of the same gender. Currently, the FDA’s draft guidance states that blood bank directors can use “discretion” when determining whether to allow transgender individuals to donate blood.
According to Bruner, currently available technology has reduced the window period in which HIV can be detected to fewer than 30 days. As a result there are two options for MSM or other members of high-risk groups to donate blood. The first would require the person donating to submit to an HIV test when the blood is drawn. The blood donation center would then hold onto that blood until the person came back 30 days later for a second HIV test. If that second test was negative, the blood could then be used safely.
The second option would be a 30-day deferral period based on behavioral reporting. For example, an MSM who had sexual contact within the past 30 days would be deferred from donating blood or other biological products.
Peter Sprigg, a senior fellow for policy studies at the Family Research Council (FRC), opposed the ban in his comments submitted on behalf of FRC, while also citing the need for science-based protocols. Sprigg noted that members of the Blood Products Advisory Committee, which met in December but failed to issue a final recommendation, had expressed reticence to change the policy, arguing that there was not enough scientific data to support the proposed change. Some committee members even commented that “blood donation is not considered a civil right and many groups are excluded from blood donation because of various risk factors.”
“Even today, we have had the odd experience of hearing the FDA explicitly renounce any intention to seek advice on this topic from its own advisory committee,” Sprigg wrote. “What this suggests to me is simple: the fix is in. The decision had already been made to change the policy, not for scientific or medical reasons, but for political ones, in order to appease the demands of a tiny, but very vocal, special interest group.”
Currently, there is no timeline as to when the FDA is expected to revise its policy — if it does so at all. According to a spokeswoman for the FDA, the agency has the option of bringing draft guidance before an advisory committee to seek recommendations, but is not required to do so, as the FDA makes the final decision on whether draft guidance is adopted.
The spokeswoman noted that some blood establishments may voluntarily choose to adopt more stringent donor deferral criteria than those recommended by the FDA. But Whitman-Walker’s Bruner says that future advances in testing technology may render any deferral period null and void, particularly if scientists and medical researchers are successful in perfecting “pathogen inactivation” technology, which would follow a process similar to milk pasteurization.
“The donated blood would be irradiated in such a way that all viruses and bacteria can be killed, and done in a way that doesn’t damage the white or red blood cells,” he says. “Once that technology is perfected, it seems like we wouldn’t need to ask anyone anything about their risk behavior. We could accept blood from everyone and treat it so that if there were any viruses or bacteria in the blood, they would be eliminated.”
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On July 14, the U.S. Food and Drug Administration (FDA) closed its period for members of the public to weigh in on its proposal to change the current lifetime ban on men who have sex with men. That proposal would change the lifetime deferral to a one-year deferral period from the time of the last sexual encounter before such men are allowed to donate blood, tissue or other biological products such as bone marrow.
Under the current policy, first adopted in 1983, men who have engaged in sex with another man — even once — since 1977 have been “indefinitely deferred” from donating blood, even if decades have passed since the sexual encounter, for fear of HIV transmission. But some LGBT rights groups, and many within the medical community, say that what essentially constitutes a lifetime ban on some groups, including gay and bisexual men, is medically and scientifically unwarranted. They argue the lifetime ban should be changed to a much shorter deferral period, given the advances in technology that can be used to detect if HIV antibodies or antigens are present in the bloodstream.
“We appreciate the fact that the FDA is willing to take another look at this,” says Daniel Bruner, the senior director of policy at Whitman-Walker Health, which specializes in HIV treatment and care. “We appreciate that they want to reduce the deferral period, but we don’t think they’ve gone nearly far enough. Once you donate blood, of course, the donated blood is tested for HIV right away. So the only concern would be the ‘window period,’ the period of time between exposure to the virus and when today’s reliable tests would find a positive result.”
Under draft guidance issued in May, the FDA is recommending the lifetime ban be changed to a one-year deferral period after the last sexual encounter. This proposed timeline is consistent with recommendations previously made by the American Red Cross, America’s Blood Centers, and the American Association of Blood Banks dating back to 2006, as well as by the federal Advisory Committee on Blood and Tissue Safety Availability, which advises the U.S. Secretary of the Department of Health and Human Services.
The one-year deferral period would also apply to other groups besides MSM, including females who have had sex with gay or bisexual men; anyone who has been treated for gonorrhea or syphilis; anyone who has received a blood transfusion in the past year; and anyone who has had any sexual contact with a person who is HIV-positive or has ever engaged in risky behaviors such as exchanging sex for money or drugs, or engaged in non-prescription drug use.
Indefinite referrals would remain in place for HIV-positive people, sex workers and non-prescription IV drug users.
The open public comment period regarding the proposed deferral period attracted 48 different comments, with many coming from members of the medical or scientific community, others from pro-LGBT organizations, and others from social conservatives opposed to changing the current policy. In all cases, commenters pleaded with the FDA to make its decision based on science, not on public pressure.
In its own comments, Whitman-Walker Health suggested that the FDA adopt a much shorter deferral period for MSM, women who have had sex with MSM, former sex workers and former IV drug users. Whitman-Walker also suggested that the FDA stop discriminating against transgender people and treat them according to the guidelines followed for cisgender individuals of the same gender. Currently, the FDA’s draft guidance states that blood bank directors can use “discretion” when determining whether to allow transgender individuals to donate blood.
According to Bruner, currently available technology has reduced the window period in which HIV can be detected to fewer than 30 days. As a result there are two options for MSM or other members of high-risk groups to donate blood. The first would require the person donating to submit to an HIV test when the blood is drawn. The blood donation center would then hold onto that blood until the person came back 30 days later for a second HIV test. If that second test was negative, the blood could then be used safely.
The second option would be a 30-day deferral period based on behavioral reporting. For example, an MSM who had sexual contact within the past 30 days would be deferred from donating blood or other biological products.
Peter Sprigg, a senior fellow for policy studies at the Family Research Council (FRC), opposed the ban in his comments submitted on behalf of FRC, while also citing the need for science-based protocols. Sprigg noted that members of the Blood Products Advisory Committee, which met in December but failed to issue a final recommendation, had expressed reticence to change the policy, arguing that there was not enough scientific data to support the proposed change. Some committee members even commented that “blood donation is not considered a civil right and many groups are excluded from blood donation because of various risk factors.”
“Even today, we have had the odd experience of hearing the FDA explicitly renounce any intention to seek advice on this topic from its own advisory committee,” Sprigg wrote. “What this suggests to me is simple: the fix is in. The decision had already been made to change the policy, not for scientific or medical reasons, but for political ones, in order to appease the demands of a tiny, but very vocal, special interest group.”
Currently, there is no timeline as to when the FDA is expected to revise its policy — if it does so at all. According to a spokeswoman for the FDA, the agency has the option of bringing draft guidance before an advisory committee to seek recommendations, but is not required to do so, as the FDA makes the final decision on whether draft guidance is adopted.
The spokeswoman noted that some blood establishments may voluntarily choose to adopt more stringent donor deferral criteria than those recommended by the FDA. But Whitman-Walker’s Bruner says that future advances in testing technology may render any deferral period null and void, particularly if scientists and medical researchers are successful in perfecting “pathogen inactivation” technology, which would follow a process similar to milk pasteurization.
“The donated blood would be irradiated in such a way that all viruses and bacteria can be killed, and done in a way that doesn’t damage the white or red blood cells,” he says. “Once that technology is perfected, it seems like we wouldn’t need to ask anyone anything about their risk behavior. We could accept blood from everyone and treat it so that if there were any viruses or bacteria in the blood, they would be eliminated.”
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