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In 2015, the Food and Drug Administration will issue a draft guidance recommending that men who have sex with men can donate blood 1 year after their last sexual contact with another man, replacing the longstanding policy that this group be deferred from donating blood indefinitely, the agency announced on Dec. 23.
The recommendation, under consideration for several years, is based on available scientific evidence, including epidemiologic data and statistical modeling of the impact of this policy change would have on blood supply safety; as well as recommendations of FDA and Department of Health and Human Services advisory committees, Dr. Peter Marks, deputy director of the FDA Center for Biologics Evaluation and Research, said during a press conference.
“Some of the most compelling data in favor of policy change come from Australia,” where HIV epidemiology is similar to that in the United States, Dr. Marks said.
Studies using a national blood surveillance system during the decade after the policy was changed in Australia from indefinite deferral of men who have sex with men (MSM) to 1 year deferral, as proposed in the United States, “documented no adverse effects” on the safety of the country’s blood supply, Dr. Marks said.
The FDA has also been working with the National Heart, Lung, and Blood Institute to implement a surveillance system to monitor the effect of the policy change on the safety of the blood supply. As the data are collected, the policy will be revisited, Dr. Marks said. The proposed policy change will also better align with the blood donor deferral period recommended for other men and women at increased risk of HIV infection, he noted.
Dr. Marks said that the currently available scientific data do not support shortening the deferral period to less than 1 year.
At a meeting in November, the federal Advisory Committee on Blood and Tissue Safety and Availability voted 16-2 to support the 1 year deferral policy for MSM.
The draft guidance will be published in the Federal Register in 2015 and will allow the public to submit comments. Dr. Marks said he could not predict whether the actual policy change would go into effect in 2015.
In 2015, the Food and Drug Administration will issue a draft guidance recommending that men who have sex with men can donate blood 1 year after their last sexual contact with another man, replacing the longstanding policy that this group be deferred from donating blood indefinitely, the agency announced on Dec. 23.
The recommendation, under consideration for several years, is based on available scientific evidence, including epidemiologic data and statistical modeling of the impact of this policy change would have on blood supply safety; as well as recommendations of FDA and Department of Health and Human Services advisory committees, Dr. Peter Marks, deputy director of the FDA Center for Biologics Evaluation and Research, said during a press conference.
“Some of the most compelling data in favor of policy change come from Australia,” where HIV epidemiology is similar to that in the United States, Dr. Marks said.
Studies using a national blood surveillance system during the decade after the policy was changed in Australia from indefinite deferral of men who have sex with men (MSM) to 1 year deferral, as proposed in the United States, “documented no adverse effects” on the safety of the country’s blood supply, Dr. Marks said.
The FDA has also been working with the National Heart, Lung, and Blood Institute to implement a surveillance system to monitor the effect of the policy change on the safety of the blood supply. As the data are collected, the policy will be revisited, Dr. Marks said. The proposed policy change will also better align with the blood donor deferral period recommended for other men and women at increased risk of HIV infection, he noted.
Dr. Marks said that the currently available scientific data do not support shortening the deferral period to less than 1 year.
At a meeting in November, the federal Advisory Committee on Blood and Tissue Safety and Availability voted 16-2 to support the 1 year deferral policy for MSM.
The draft guidance will be published in the Federal Register in 2015 and will allow the public to submit comments. Dr. Marks said he could not predict whether the actual policy change would go into effect in 2015.
In 2015, the Food and Drug Administration will issue a draft guidance recommending that men who have sex with men can donate blood 1 year after their last sexual contact with another man, replacing the longstanding policy that this group be deferred from donating blood indefinitely, the agency announced on Dec. 23.
The recommendation, under consideration for several years, is based on available scientific evidence, including epidemiologic data and statistical modeling of the impact of this policy change would have on blood supply safety; as well as recommendations of FDA and Department of Health and Human Services advisory committees, Dr. Peter Marks, deputy director of the FDA Center for Biologics Evaluation and Research, said during a press conference.
“Some of the most compelling data in favor of policy change come from Australia,” where HIV epidemiology is similar to that in the United States, Dr. Marks said.
Studies using a national blood surveillance system during the decade after the policy was changed in Australia from indefinite deferral of men who have sex with men (MSM) to 1 year deferral, as proposed in the United States, “documented no adverse effects” on the safety of the country’s blood supply, Dr. Marks said.
The FDA has also been working with the National Heart, Lung, and Blood Institute to implement a surveillance system to monitor the effect of the policy change on the safety of the blood supply. As the data are collected, the policy will be revisited, Dr. Marks said. The proposed policy change will also better align with the blood donor deferral period recommended for other men and women at increased risk of HIV infection, he noted.
Dr. Marks said that the currently available scientific data do not support shortening the deferral period to less than 1 year.
At a meeting in November, the federal Advisory Committee on Blood and Tissue Safety and Availability voted 16-2 to support the 1 year deferral policy for MSM.
The draft guidance will be published in the Federal Register in 2015 and will allow the public to submit comments. Dr. Marks said he could not predict whether the actual policy change would go into effect in 2015.
