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Joint Statement on FDA Draft Guidance for Deferral Criteria for MSM

 

Joint Statement on FDA Draft Guidance for Deferral Criteria for MSM

May 12, 2015

AABB, America’s Blood Centers and the American Red Cross issued the following joint statement regarding new U.S. Food and Drug Administration draft guidance for deferral criteria for men who have had sex with men (MSM):

“AABB, America’s Blood Centers and the American Red Cross are pleased that the new draft guidance has been issued regarding deferral criteria for men who have had sex with men (MSM). We will review the draft put forward by the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA) and will respond to the guidance in a timely manner.

The top priorities of the blood banking community are the safety of our volunteer blood donors and the ultimate recipients of blood. AABB, America’s Blood Centers and the Red Cross continue to support the recommendation to change the current indefinite deferral of MSM to a 12-month deferral. 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.

It is important to note that this process is just beginning and that the lifetime blood donation deferral for MSM remains in place. All blood centers continue to comply with the current FDA blood donation eligibility criteria until the guidance is finalized.

When released, the final FDA guidance will describe a pathway for previously deferred donors to give blood. Once that is defined, it will take some time for blood centers to update their systems and put those changes into operation.”