The American Red Cross is asking the Food and Drug Administration to reconsider its blood donation restrictions on gay and bisexual men.
Under current FDA policy, men are banned from donating if they have had sex with another man in the past year. Until December 2015, men who have sex with men (MSM) and transgender women were prohibited from donating blood altogether. That policy was revised to a 12-month blood donor deferral since last MSM contact, and a restructuring from a determination of gender based on sex assigned at birth to that which is “self-reported and self-identified.”
The Red Cross is recommending the FDA revise its policy further to a three-month ban, which is the current standard in several other countries, including Canada and England. In a statement, the organization called the plan “a scientifically-based interim step” and said it also “strongly support(s) the expanded use of new technologies to work toward elimination of donor eligibility questions that would no longer be necessary.”
It went so far as to say outright that it does not believe blood donation should be determined based upon sexual orientation and that it is “committed to working toward achieving this goal.”
The organization noted it “is regulated by the FDA and cannot unilaterally enact changes in the MSM deferral policy,” while adding that it will “continue to work with other U.S. blood collection organizations to gather and provide data to the FDA for additional research and evaluation.”
“We ask advocates and stakeholders to join us in this important dialogue around the existing deferral policy and pathways toward achieving our goal, while recognizing the need to always maintain patient safety,” the Red Cross added. “Together, we will work toward an inclusive and equitable blood donation process that treats all potential donors with equality and respect, and ensures a safe, sufficient blood supply is readily available for patients in need.”
NewNowNext has contacted the FDA for comment and this article will be updated if we receive a response.
The FDA sent a lengthy statement to NewNowNext regarding its policy on blood donations from MSM, which it characterizes as “a behavior-based policy, not one based upon sexual orientation,” and points to a Q&A document available on its website regarding circumstances where the FDA recommends deferrals.
“Among other studies reviewed at the time [of the 2015 policy change regarding MSM], epidemiologic studies in blood donors showed that a history of male-to-male sexual contact was associated with a 62-fold increased risk for being HIV positive, whereas the increase in risk for a history of multiple sexual partners of the opposite sex in the last year was 2.3-fold. While acknowledging at the time that the change to a 12-month deferral was less than hoped for by some, the FDA considered this to be a first step in the process of evaluating and progressing its blood donor deferral policies for all donors,” the statement continues.
“Developing the scientific information that is needed to further change blood donor policies does take time and effort. The FDA has made forward progress in this regard. A blood safety surveillance system to look at more than half of the blood collected in the U.S. is fully operational and providing data that will help inform further changes in policy,” the agency states.
“In addition, the FDA sought public input to collect insights on how we might move to and test alternative deferral strategies, such as individual risk assessment, and the agency has initiated work on a questionnaire study that will involve men at risk for HIV to evaluate novel donor assessment strategies. The FDA is also involved in an ongoing dialogue with stakeholders regarding the policy.”
The statement further notes the FDA’s Blood Product Advisory Committee met in open session on March 21 of this year to discuss the policies regarding MSM, where it was presented with “presentations on the current epidemiology of HIV in the U.S.; global developments in MSM blood donor deferral policies; and, data on HIV incidence and prevalence among blood donors from the Transfusion-Transmitted Infection Monitoring System.”
“The Committee also discussed the HIV risk questionnaire study noted above and a proposal for the use of pathogen reduction technology to allow MSM to donate platelets without a deferral as an alternative procedure to a time-based deferral for MSM,” the statement adds. “The FDA did not ask for a vote on specific issues. However, the committee discussed and made recommendations on the information presented.”
“We will continue to work in a timely manner with all stakeholders to develop the scientific information needed to further progress blood donor deferral policies that are fair and equitable for all donors and that ultimately enhance the overall safety of the blood supply.”