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  • Washington Highlights

    FDA Finalizes Recommendations on Blood Donor Eligibility


    Heather Pierce, Senior Director, Science Policy & Regulatory Counsel
    For Media Inquiries

    The Food and Drug Administration (FDA) on May 11 finalized recommendations for reducing the risk of HIV transmission through evaluation of blood donor eligibility. The final recommendations are consistent with the draft policy initially proposed on Jan. 27. As stated in the press release announcing the final revisions, the “FDA has worked diligently to evaluate [its] policies and ensure [the agency] had the scientific evidence to support individual risk assessment for donor eligibility while maintaining appropriate safeguards to protect recipients of blood products.”

    In its comments on the draft recommendations, the AAMC expressed support for the revisions, noting that 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 association also urged the FDA to coordinate communications about the revised policy with the Centers for Disease Control and Prevention and the National Institutes of Health and encouraged the FDA to periodically revisit its final recommendations [refer to Washington Highlights, April 7].