ASH Statement on FDA's Proposed New Blood Donor Eligibility Guidelines
ASH applauds FDA guidance to further expand blood donor eligibility criteria
(WASHINGTON, January 27, 2023) — Today the U.S. Food and Drug Administration (FDA) announced updated guidance for blood donation, recommending the elimination of time-based donation deferrals for men who had sex with men (MSM) and women who have sex with MSM. The new recommendations focus instead on use of questionnaires that assess individual donor risk of HIV based on sexual history and recent partners. Donated blood will continue to be screened for all relevant blood-borne pathogens.
The American Society of Hematology (ASH) applauds the FDA for taking steps to address the significant challenges to maintaining the national blood supply and to further encourage blood donations from all healthy people. ASH is currently reviewing the draft guidance and will submit feedback to the FDA as part of the open comment period.
The new FDA guidance recommends the following:
- Blood donation centers providing educational material to donors before each donation that outline the risk of HIV transmission by blood and blood products and risk factors associated with HIV infections;
- Eliminating donation deferrals for men who have sex with men (MSM) and women who have sex with MSM;
- Assessing donor eligibility using gender-inclusive individual risk-based questions relevant to HIV risk; and
- Deferring donors who are actively taking medications to treat or prevent HIV infection.
Maintaining a safe and sufficient blood supply is vital to supporting public health. ASH is especially concerned with ensuring an adequate supply of safe blood and blood products for individuals with hematologic conditions, including individuals with blood cancers, hemophilia, and sickle cell disease (SCD) for whom transfusions can prevent complications and be lifesaving.
ASH continues to support and promote efforts by blood banks and centers to encourage blood donations, particularly as the national blood shortage persists since the COVID-19 pandemic, among other factors. Last year, the Society issued a policy statement advocating for the maintenance of a strong blood supply. The statement encouraged the FDA to conduct additional research to better inform donor policies and to safely maximize eligibility criteria and eliminate unwarranted biased exclusions of marginalized populations.
“The new guidelines proposed by the FDA, if implemented, would expand the pool of eligible donors, and ultimately strengthen our national blood supply. The individuals with blood disorders who our members treat depend on a strong blood supply for optimal care and management of their conditions,” said ASH President Robert A. Brodsky, MD, of Johns Hopkins University School of Medicine. “We applaud FDA’s efforts to make evidence-based decisions in the development of safe and inclusive guidance that will adequately screen donors for HIV without discriminating against people on the basis of their sexual activity or identity.”
- ASH Statement on a Strong Blood Supply
- FDA Guidance Document: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products
The American Society of Hematology (ASH) (www.hematology.org) is the world’s largest professional society of hematologists dedicated to furthering the understanding, diagnosis, treatment, and prevention of disorders affecting the blood. For more than 60 years, the Society has led the development of hematology as a discipline by promoting research, patient care, education, training, and advocacy in hematology. ASH’s flagship journal, Blood is the most cited peer-reviewed publication in the field, and Blood Advances is an open-access, online journal that publishes more peer-reviewed hematology research than any other academic journal worldwide.
Kira Sampson, American Society of Hematology
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