Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg said the following today in a statement concerning the blood donor deferral period for men who have sex with men (MSM):
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.
Following this review, and taking into account the recommendations of advisory committees to the U.S. Department of Health and Human Services (HHS) 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.
This recommended change is consistent with the recommendation of an independent expert advisory panel the HHS Advisory Committee on Blood and Tissue Safety and Availability, and will better align the deferral period with that of other men and women at increased risk for HIV infection.
Additionally, in collaboration with the NIH’s National Heart Lung and Blood Institute (NHLBI), 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.
The FDA intends to issue a draft guidance recommending this proposed change in policy in 2015, which will also include an opportunity for public comment.