The FDA proposes to ease its lifetime ban on blood donations by men who have sex with men (MSM), but proposes to block donations by MSM within the last year. Here’s the rationale.
The FDA plans to ease its lifetime ban on blood donations by men who have sex with men (MSM). But it has proposed to block donations by MSM within the last year.
“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 MSM, including the results of several recently completed scientific studies and recent epidemiologic data,” said FDA Commissioner Margaret A. Hamburg in a statement. “Following this review, and taking into account the recommendations of advisory committees to the US 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 MSM from indefinite deferral to 1 year since the last sexual contact.”
In addition, in collaboration with the NIH’s National Heart, Lung, and Blood Institute, “the FDA has already taken steps to implement a national blood surveillance system that will help the agency monitor the effect of a policy change and further help to ensure the continued safety of the blood supply,” she said.
The FDA intends to issue a draft guidance recommending this proposed change in policy in 2015, which will also include an opportunity for public comment.
FDA’s policies on donor deferral for MSM dates back to 1983, when the risk of AIDS from transfusion was first recognized.
MSM are currently deferred as blood donors because, the FDA states, they are, as a group, at increased risk for HIV, hepatitis B, and certain other infections that can be transmitted by transfusion.
A history of male-to-male sex is associated with an increased risk for exposure to and transmission of certain infectious diseases-including human immunodeficiency virus (HIV). MSM represent approximately 2% of the US population, yet are the population most severely affected by HIV.
In 2010, MSM accounted for almost two-thirds of all new HIV infections in the US. About three-quarters of diagnosed HIV infections among males were attributed to male-to-male sexual contact.
Between 2008 and 2010, the estimated overall incidence of HIV was stable in the US. However the incidence in MSM increased 12%, while it decreased in other populations.
The largest increase was a 22% increase in MSM with men aged 13 to 24 years. Since younger individuals are more likely to donate blood, the implications of this increase in incidence need to be further evaluated, the FDA stated.
Some gay rights groups feel the proposed FDA policy is still discriminatory for excluding some MSM, including those who have had a low number of partners, practice safe sex, or who are currently in monogamous relationships. “FDA's deferral policy is based on the documented increased risk of certain transfusion transmissible infections, such as HIV, associated with male-to-male sex and is not based on any judgment concerning the donor’s sexual orientation,” the FDA stated.
The FDA Commissioner released her statement on December 23, 2014.