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Following up on a March announcement from the Department of Health and Human Services, the June meeting of the Advisory Committee on Blood Safety and Availability ”will hear presentations and engage in deliberations” on the Food and Drug Administration policy, in place in its current form since September 1985, prohibiting men who have had sex with another man ”even one time since 1977” from donating blood.
Officials at HHS and advocacy groups said that no decision on the specifics of any change – or if there even would be any change – has been made. Unlike the FDA reviews of the policy in 2000 and 2006, however, the Advisory Committee will be free to consider non-scientific factors – like societal issues and cost-benefit analysis – in its review.
The meeting, formally announced in the Federal Register on Thursday, May 20, is to take place June 10-11 at The Universities at Shady Grove in Rockville, Maryland.
Jerry A. Holmberg, the executive secretary of the Advisory Committee, said on Thursday, ”The decision has been to review the issue. The Assistant Secretary of Health wants this to be discussed in an open forum.”
The Human Rights Campaign announced in a release that the organization will offer testimony at the meeting. Spokesman Michael Cole spoke to the additional work needed to effect any policy change, saying, ”This is a long-standing policy that will take a great deal of education to help change.”
Cole noted ”the FDA’s paramount responsibility is to ensure the safety of the blood supply.” Regarding HRC and other advocates of changing the policy, Cole said, ”We must continue working to demonstrate that broadly excluding all gay and bisexual donors for life, particularly in light of tremendous advances in HIV science since the ban was adopted, does not serve that important goal.”
The lifetime ban – called a lifetime deferral by the FDA policy – often has sparked the ire of LGBT advocates in the past and also is opposed by the three main blood donations organizations – the AABB, America’s Blood Centers (ABC) and the American Red Cross.
In a 2006 statement, the three groups stated that the lifetime ban is ”medically and scientifically unwarranted.” It should be noted, however, that they ”recommend that deferral criteria be modified and made comparable with criteria for other groups at increased risk for sexual transmission of transfusion-transmitted infections,” which would be a one-year deferral. The recommendation, if implemented, would mean that only those men who have not had sex with another man for more than a year would be eligible to donate blood.
The meeting notice states that the topics to be addressed include: ”what are the most important factors (e.g. societal, scientific, and economic) to consider in making a policy change; is the currently available scientific information including risk assessments sufficient to support a policy change at this time; what studies, if any, are needed before implementing a policy change; what monitoring tools or surveillance activities would need to be in place before implementing a policy change; what additional safety measures, if any, are needed to assure blood safety under a revised deferral policy?”
The notice includes additional information, including a note that ”screening tests can be falsely negative during the ‘window period,’ defined as the interval between the time when an infected individual may transmit the disease and the time when screening tests become positive.” In agreement with the AABB, ABC and Red Cross statement, the notice states, ”A period of deferral is needed after high-risk exposure to prevent false negative tests from ‘window period’ collections.”
The June 10-11 meeting will include a period for public comment on June 11. Anyone who wishes to comment is required to register with Holmberg by June 8.
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