Due to the enhanced safety measures now used in the manufacture of clotting factor concentrates, FDA no longer considers those products a risk for HIV. For other behavioral deferrals such as commercial sex workers and injection drug use, insufficient data are available to support a change to the existing deferral recommendations at this time.įDA is also changing its deferral recommendation rationale for those who have hemophilia or related clotting disorders.
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Prior to the current guidance, FDA’s recommendations were outlined in the April 1992 memorandum, “Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products.” Based on the evidence now available, FDA has changed its recommendation from the indefinite deferral for MSM to a 12 month blood donor deferral since last MSM contact. What changes have been made to FDA's recommendations? In November 2014, these results were presented to the HHS Advisory Committee for Blood and Tissue Safety and Availability (the committee that succeeded the ACBSA), which, after considering the results, recommended that a shorter deferral period was appropriate. Once the studies were completed in 2014, the FDA along with other Public Health Service agencies, including the Centers for Disease Control and Prevention, Health Resources and Services Administration, National Institutes of Health, and the Office of the Assistant Secretary for Health, assessed the results of the studies. In 2010, the ACBSA found that the deferral policy for men who have had sex with other men (MSM) was suboptimal and it recommended that studies be conducted to better inform a potential policy change.
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These reviews have been undertaken publicly at meetings of the FDA Blood Products Advisory Committee and the HHS Advisory Committee for Blood Safety and Availability (ACBSA). The FDA has revisited its donor deferral recommendations to reduce the risk of transmitting human immunodeficiency virus (HIV) several times over the past 10 years.
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Questions and Answers for Potential Blood Donors and Blood Recipients