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FDA recommends changing blood donor policy for MSM

Blood for transfusion

Photo by Elisa Amendola

The US Food and Drug Administration (FDA) is recommending a change to the policy that prevents men who have sex with men (MSM) from donating blood, according to FDA Commissioner Margaret A. Hamburg.

The FDA would like to allow MSM to donate blood if they have abstained from sexual contact for 1 year.

The agency intends to issue a draft guidance recommending this policy change in 2015. The guidance will be open for public comment.

In a prepared statement, Hamburg said that, over the past few years, the FDA and other government agencies have carefully considered the scientific evidence relevant to the blood donor deferral policy for MSM.

This review, as well as the recommendations of advisory committees to the US Department of Health and Human Services (HHS) and the FDA, has prompted the FDA to recommend the change.

“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,” Hamburg said.

“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.”

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Blood for transfusion

Photo by Elisa Amendola

The US Food and Drug Administration (FDA) is recommending a change to the policy that prevents men who have sex with men (MSM) from donating blood, according to FDA Commissioner Margaret A. Hamburg.

The FDA would like to allow MSM to donate blood if they have abstained from sexual contact for 1 year.

The agency intends to issue a draft guidance recommending this policy change in 2015. The guidance will be open for public comment.

In a prepared statement, Hamburg said that, over the past few years, the FDA and other government agencies have carefully considered the scientific evidence relevant to the blood donor deferral policy for MSM.

This review, as well as the recommendations of advisory committees to the US Department of Health and Human Services (HHS) and the FDA, has prompted the FDA to recommend the change.

“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,” Hamburg said.

“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.”

Blood for transfusion

Photo by Elisa Amendola

The US Food and Drug Administration (FDA) is recommending a change to the policy that prevents men who have sex with men (MSM) from donating blood, according to FDA Commissioner Margaret A. Hamburg.

The FDA would like to allow MSM to donate blood if they have abstained from sexual contact for 1 year.

The agency intends to issue a draft guidance recommending this policy change in 2015. The guidance will be open for public comment.

In a prepared statement, Hamburg said that, over the past few years, the FDA and other government agencies have carefully considered the scientific evidence relevant to the blood donor deferral policy for MSM.

This review, as well as the recommendations of advisory committees to the US Department of Health and Human Services (HHS) and the FDA, has prompted the FDA to recommend the change.

“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,” Hamburg said.

“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.”

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