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  • Washington Highlights

    AAMC Submits Letter to FDA on Revised Blood Donation Guidelines

    Heather Pierce, Senior Director, Science Policy & Regulatory Counsel

    The AAMC submitted a March 31 letter to the Food and Drug Administration (FDA) in response to draft revisions to the FDA’s recommendations for reducing the risk of human immunodeficiency virus (HIV) transmission through evaluation of blood donor eligibility. 

    In the letter, the AAMC supported the revisions, noting that the existing standards constitute a “discriminatory prohibition based on gender and sexual orientation alone [that] has been stigmatizing to the LGBTQ+ community and has negatively impacted the size of the blood donor pool.” The AAMC expressed approval of the movement towards a “more gender-inclusive and individual risk-focused set of criteria for donation eligibility.” 

    The AAMC’s comments also urged the FDA to coordinate communications about revised recommendations with the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH). Successful public health efforts by NIH and CDC to encourage the use of pre-exposure prophylaxis and anti-retrovirals include the “U=U” or “undetectable equals untransmissible” campaign. The FDA’s revised standards suggest that individuals taking either of these treatments should not be eligible for blood donation, as there remains a very small risk of transmission through transfusion, even without a detectable HIV viral load.  AAMC urged additional research in this area and encouraged the FDA to revisit its recommendations periodically.