[FDA has issued its “Final Guidance” on the modification of the MSM policy from a lifetime to a one-year deferral.]
After many years of supporting a science-based change in the lifetime deferral of men who have had sex with men, NYBC is pleased to see this announcement from the FDA, coming after a one-year period of public review and comment.
We do caution, however, that the policy change will not be immediate. Changes to the donor questionnaire must be made and submitted to the FDA for approval (this will be the case for all blood centers in the country). New York Blood Center looks forward to implementing the change – as soon as the FDA says we can – for the benefit of our communities and the blood supply. We will also support any additional science-based reform efforts the FDA chooses to undertake.
Further, NYBC will continue its role of providing significant medical data to the FDA, starting a new project with a consortium of other blood centers to estimate the incidence and prevalence of HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV) infections and characterize the demographics of donors with these infections. We will conduct risk factor interviews of donors with specific infections focused primarily on HIV and newly acquired HBV or HCV infections to identify behavioral factors associated with donor infections; as well as genotyping identified viruses.