On 5/12/2015 FDA issued a draft guidance,"Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products", to recommend a change in the blood donor deferral period for men who have sex with men (MSM) from indefinite deferral to one year since the last sexual contact with another man.
As noted in a December 23, 2014 HIV list serve notice, FDA has worked with other government agencies, considered input from external advisory committees, and carefully examined the scientific evidence to support this proposed policy revision.
This guidance will be open for public comment for 30 days. We encourage all interested parties to provide input, including any information they believe the FDA should consider related to donor deferral policy for MSM and other recommendations in the draft guidance.
Comments on the draft guidance can be submitted directly through www.regulations.gov. Finalizing the guidance is a priority for the agency. After careful consideration of the comments received, FDA will incorporate any necessary changes and will finalize the guidance as quickly as possible.
In developing the draft guidance, FDA examined a variety of recent studies, epidemiologic data, and shared experiences from other countries that have made recent MSM deferral policy changes. In addition, the FDA carefully reviewed the results of studies in Australia, which demonstrated that a change from an indefinite deferral to a one-year deferral for MSM in 2000 did not result in an adverse effect on the safety of the blood supply.
The recommended change better aligns the deferral period for MSM with the one-year deferral period for other men and women at increased risk for HIV infection, reflects current scientific evidence showing that an adverse effect on the safety of the blood supply is unlikely, and is likely to improve MSM adherence to the deferral period. Indefinite deferral recommendations will remain in place for injection drug users and commercial sex workers. Compelling scientific evidence is not available at this time to support a change to a deferral period less than one year while still ensuring the safety of the blood supply.
As science continues to evolve, FDA will look at ways to further improve donor deferral policies, to ensure the policy reflects the most up-to-date scientific knowledge.
FDA will first monitor the outcome of the proposed recommended change to one year deferral for MSM to assure that blood safety is maintained before considering any further policy change.
Blood establishments will be able to implement changes to the blood donor deferral for MSM after the final guidance has issued and standard operating procedures for the facility have been reviewed and approved.
Additional background information about the MSM donor deferral policy, and links to records from public meetings on the issue between 1998 - 2014 are available on the FDA Blood Donor Deferral website.
Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration
This guidance will be open for public comment for 30 days. We encourage all interested parties to provide input, including any information they believe the FDA should consider related to donor deferral policy for MSM and other recommendations in the draft guidance.
Comments on the draft guidance can be submitted directly through www.regulations.gov. Finalizing the guidance is a priority for the agency. After careful consideration of the comments received, FDA will incorporate any necessary changes and will finalize the guidance as quickly as possible.
In developing the draft guidance, FDA examined a variety of recent studies, epidemiologic data, and shared experiences from other countries that have made recent MSM deferral policy changes. In addition, the FDA carefully reviewed the results of studies in Australia, which demonstrated that a change from an indefinite deferral to a one-year deferral for MSM in 2000 did not result in an adverse effect on the safety of the blood supply.
The recommended change better aligns the deferral period for MSM with the one-year deferral period for other men and women at increased risk for HIV infection, reflects current scientific evidence showing that an adverse effect on the safety of the blood supply is unlikely, and is likely to improve MSM adherence to the deferral period. Indefinite deferral recommendations will remain in place for injection drug users and commercial sex workers. Compelling scientific evidence is not available at this time to support a change to a deferral period less than one year while still ensuring the safety of the blood supply.
As science continues to evolve, FDA will look at ways to further improve donor deferral policies, to ensure the policy reflects the most up-to-date scientific knowledge.
FDA will first monitor the outcome of the proposed recommended change to one year deferral for MSM to assure that blood safety is maintained before considering any further policy change.
Blood establishments will be able to implement changes to the blood donor deferral for MSM after the final guidance has issued and standard operating procedures for the facility have been reviewed and approved.
Additional background information about the MSM donor deferral policy, and links to records from public meetings on the issue between 1998 - 2014 are available on the FDA Blood Donor Deferral website.
Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration
