FDA Commissioner Margaret A. Hamburg's statement on FDA’s blood donor deferral policy for men who have sex with men

The U.S. Food and Drug Administration is a science-based regulatory agency that works to protect and promote the public health. In this role, it is our responsibility to regulate the blood supply and to help ensure its continued safety for the patients who receive these life-saving products.

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The FDA intends to issue a draft guidance recommending this proposed change in policy in 2015, which will also include an opportunity for public comment. We encourage all stakeholders to take this opportunity to provide any information the agency should consider, and look forward to receiving and reviewing these comments.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human drugs, including vaccines and other biological products for human use, veterinary drugs, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.