FDA Statement on Blood Donor Deferral Policy for Men Who Have Sex with Men
In May 2015, the U.S. Food and Drug Administration (FDA) issued draft guidance for industry on the FDA’s blood donor lifetime deferral policy for men who have had sex with men (MSM). The FDA’s draft guidance is a proposed change to the blood donor deferral period for MSM from indefinite deferral to 12 months since the last sexual contact.
The draft guidance is not meant for implementation, but rather is issued for any member of the public to comment on the proposed change prior to the FDA determining if there will be a policy change.
To read the full FDA draft guidance and learn how to make a comment, visit http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/
Guidances/Blood/UCM446580.pdf
Stanford Blood Center Policy
At present, the FDA policy regarding MSM is still an indefinite deferral. Therefore, at this time, all U.S. blood banks – including Stanford Blood Center – are obliged to continue to follow the current indefinite deferral policy.
Additional information about SBC’s current MSM deferral is available at http://bloodcenter.stanford.edu/donate/MSMDeferral.html
As an organizational member of America’s Blood Centers, Stanford Blood Center supports the recommendation to change the current indefinite deferral for MSM to a 12-month deferral as proposed in the recently released draft guidance. As stated in a joint statement released in December 2014 by AABB, America’s Blood Centers, and American Red Cross, “This change in policy would align the donor deferral period for MSM with criteria for other activities that may pose a similar risk of transfusion-transmissible infections.”
Next Steps
We are awaiting the FDA’s next steps, which will come after the 60-day public comment period.
We will update this page as developments occur.
For more information from the FDA regarding MSM policy, visit http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/QuestionsaboutBlood/ucm108186.htm