The U.S. Food and Drug Administration (FDA) announced Tuesday that it was moving forward with recommendations that would change the lifetime ban on accepting blood and tissue donations from gay, bisexual and other men who have sex with men (MSM) to a one-year deferral period from a potential donor’s last sexual liaison.
The policy change incorporates a recommendation from the federal Advisory Committee on Blood and Tissue Safety Availability (ACBTSA), which is tasked with advising the Secretary of the Department of Health and Human Services. The advisory committee met in November to discuss the possibility of changing the current policy, first adopted in 1983, which recommends “indefinite deferral” for male blood donors who have ever engaged in sexual activity — even once — with other men since 1977, to one that is more science-based. The advisory committee voted 16-2 at its November meeting to change the period of indefinite deferral to a one-year period.
Under the new recommendations, MSM who are abstinent for one year after their last sexual encounter would be cleared to donate blood or organs to those in medical need. This change would see MSM treated in a similar way as other groups of heterosexuals considered at high risk of HIV, including those with HIV-positive partners, intravenous drug users, and commercial sex workers. The policy would mirror similar ones placed on blood donors in countries like Australia, Great Britain and Japan — which impose a one-year deferral period — and South Africa, which recently revised its policy from one that asked MSM to abstain for six months before donating to a policy with an across-the-board deferral for any man or woman, gay or straight, who has had a new sexual partner in the past six months.
FDA Commissioner Margaret A. Hamburg released a statement announcing the change, citing the agency’s reliance on scientific evidence as justification while also stressing that the FDA’s priority was focused on regulating the blood supply in a way that would ensure the safety of patients in need of blood and tissue donations.
“Over the past several years, in collaboration with other government agencies, the FDA has carefully examined and considered the available scientific evidence relevant to its blood donor deferral policy for men who have sex with men, including the results of several recently completed scientific studies and recent epidemiologic data,” Hamburg said. “Following this review, and taking into account the recommendations of advisory committees to the U.S. Department of Health and Human Services and the FDA, the agency will take the necessary steps to recommend a change to the blood donor deferral period for men who have sex with men from indefinite deferral to one year since the last sexual contact.”
Hamburg also added that the FDA has already taken steps to implement a national blood surveillance system that will help monitor the effect of the policy change while ensuring the blood supply remains free of HIV and other diseases. She said the agency will issue a draft guidance recommending the policy change in 2015, and will allow the opportunity for public comment before fully implementing the new guidelines.
While many allies of the LGBT community acknowledged the importance of the FDA’s willingness to rescind the lifetime ban for gay and bisexual men, they also said that they would not be satisfied with the new one-year deferral period, which they argue is still discriminatory and not grounded in science.
“While this new policy is movement toward an optimal policy that reflects fundamental fairness and the best scientific research, it falls far short of an acceptable solution because it continues to stigmatize gay and bisexual men, preventing them from donating life-saving blood based solely on their sexual orientation, rather than a policy based on actual risk to the blood supply,” said David Stacy, government affairs director for the Human Rights Campaign (HRC), the nation’s top LGBT civil rights organization. “This new policy cannot be justified in light of current scientific research and updated blood screening technology. We will continue to work towards an eventual outcome that both minimizes risk to the blood supply and treats gay and bisexual men with the respect they deserve.”
The American Civil Liberties Union (ACLU) also decried the proposed recommendation in its own statement.
“The FDA’s proposal must be seen as part of an ongoing process and not an end point,” ACLU Legislative Representative Ian Thompson said. “The reality for most gay and bisexual men — including those in committed, monogamous relationships — is that this proposal will continue to function as a de facto lifetime ban. Criteria for determining blood donor eligibility should be based on science, not outdated, discriminatory stereotypes and assumptions.”
Caleb Laieski, a 19-year-old LGBT rights advocate living in Alexandria, Va., is the plaintiff in a recent lawsuit against the FDA over its current blood donation policy. The U.S. Department of Justice (DOJ), in representing the FDA, has requested that the lawsuit be dismissed due to the FDA’s willingness to revise the policy. Nevertheless, Laieski has previously vowed not to stop fighting until the FDA lifts the restrictions placed on gay and bisexual men.
“Today, progress was certainly made and more lives will be saved because of it,” Laieski said in a statement responding to the announcement. “However, the one-year ban is still discriminatory and unnecessary. As HHS and the FDA clearly state, their testing is extremely accurate and the window period for HIV and STDs to show up is way under a year, so the year ban is still mind-blowing and non-science-based.”
The Family Research Council (FRC), a right-wing, pro-family organization that opposes homosexuality, objected to the FDA’s willingness to amend its policy, pointing to the refusal of the FDA’s Blood Products Advisory Committee, which met on Dec. 2, to vote on any recommendation similar to the one approved by the Advisory Committee on Blood and Tissue Safety Availability.
“Members of the Blood Products Advisory Committee were clearly reluctant to recommend any change to the current policy in the absence of a national program of comprehensive monitoring of the entire blood transfusion system from donor to recipient,” Peter Sprigg, senior policy counsel for the FRC, said in a statement. “Research presented to the Committee confirmed the dramatically elevated risk of HIV infection among men who have sex with men (MSM) — a risk 62 times higher than in the general public. This risk certainly justifies the highest level of vigilance, and political and social concerns must not be allowed to trump the public health.”
Sprigg continued: “It is shocking that the FDA did not even wait for a recommendation from their own Advisory Committee before rushing to the politically correct decision demanded by homosexual activist groups. Yet the Obama administration has apparently dragged its heels in implementing this important safeguard, which should be a pre-requisite to any change in policy.”
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