FDA Announces New Blood Donation Policy, Orgs Say It Does Not Go Far Enough
The U.S. Food and Drug Administration (FDA) Monday announced new guidelines for blood donations that change the current lifetime ban for men who have sex with men (MSM) to a one-year ban. The guidelines also make clear that transgender individuals may self-report their gender for purposes of applying the MSM policy.
“The FDA’s responsibility is to maintain a high level of blood product safety for people whose lives depend on it,” said the FDA’s Acting Commissioner Stephen Ostroff, M.D. “We have taken great care to ensure this policy revision is backed by sound science and continues to protect our blood supply.”
According to a news release, the FDA reviewed its policies regarding HIV transmission through blood products to determine appropriate changes based on the most recent scientific evidence. Moving forward, the FDA will continue to reevaluate its blood donor deferral policies as new scientific information becomes available.
“Using the approach of following the best available science together with use of donor education materials, specific deferral questions and advances in HIV donor testing has helped the FDA reduce the HIV transmission rates from blood transfusion from 1 in 2,500 to 1 in 1.47 million,” the release said. “As part of today’s finalized blood donor deferral guidance, the FDA is changing its recommendation that men who have sex with men be indefinitely deferred – a policy that has been in place for approximately 30 years – to 12 months since the last sexual contact with another man. These updated recommendations better align the deferral period for MSM with the deferral period for other men and women at increased risk for HIV infection – such as those who had a recent blood transfusion or those who have been accidentally exposed to the blood of another individual. The FDA examined a variety of recent studies, epidemiologic data, and shared experiences from other countries that have made recent MSM deferral policy changes.”
“In reviewing our policies to help reduce the risk of HIV transmission through blood products, we rigorously examined several alternative options, including individual risk assessment,” said Peter Marks, M.D., Ph.D., deputy director of the FDA’s Center for Biologics Evaluation and Research. “Ultimately, the 12-month deferral window is supported by the best available scientific evidence, at this point in time, relevant to the U.S. population. We will continue to actively conduct research in this area and further revise our policies as new data emerge.”
The AABB, America’s Blood Centers and the American Red Cross issued the following joint statement: “AABB, America’s Blood Centers and the American Red Cross are pleased that the FDA has released its final guidance regarding deferral criteria for men who have had sex with men. The top priority of the blood banking community is the safety of our volunteer blood donors and the recipients of blood. AABB, America’s Blood Centers and the Red Cross support the FDA’s decision to change the MSM blood donation policy from a lifetime deferral to a one-year deferral. This policy change aligns the MSM donor deferral period with those for other activities that may pose a similar risk of transfusion-transmissible infections.”
The statement continued, “While the final FDA guidance describes a pathway for previously deferred donors to give blood, it will take several months for blood centers to update their computer systems, modify processes and procedures, train staff and implement these extensive changes. Our blood banks will work diligently to determine a process for the reinstatement of eligible donors who were deferred under the previous MSM policy; however, it is important to understand that this process will take time.”
While a step in the right direction, some say the new guidance falls short of what many recognize as the optimal policy for enhancing the safety of the blood supply while ensuring it does not discriminate against gay, bisexual and transgender people.
“It is ridiculous and counter to the public health that a married gay man in a monogamous relationship can’t give blood, but a promiscuous straight man who has had hundreds of opposite sex partners in the last year can,” said Jared Polis, a Democratic congressman and co-chair of the Congressional LGBT Equality Caucus, a caucus of openly gay members of Congress.
The National Gay Blood Drive said in a statement: “We are pleased to see the FDA has issued the final guidance and we support this initial policy change that will allow gay and bisexual men to donate for the first time in 32 years. However, the revised policy is still discriminatory. While gay and bisexual men will be eligible to donate their blood and help save lives under this 12 month deferral, countless more will continue to be banned solely on the basis of their sexual orientation and without medical or scientific reasoning. So today we begin the final push to eliminate discrimination based on sexual orientation from the blood donation process altogether. We strongly encourage the FDA to move toward a deferral based upon individual risk assessment. We will commence organizing the National Gay Blood Drive immediately in conjunction with the implementation of the revised MSM blood donor policy.”
Scott Schoettes, Lambda Legal Senior Attorney and HIV Project Director, said of the announcement: “The guidance published today does not go far enough. An evidence-based policy would focus exclusively on the conduct of the potential donor, rather than the person’s identity with regards to sexual orientation, gender identity or perceived risk factors based on the person’s identity. Risk behaviors do not have a sexual orientation or gender identity.