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May 11, 2023

America’s Blood Centers Supports Final FDA Guidance Implementing Individual Blood Donor Assessments

By America's Blood Centers

Washington, DC – America’s Blood Centers (ABC), the national organization of community-based, independent blood centers that supply 60 percent of the nation’s blood supply, supports the Food and Drug Administration (FDA) final guidance released today that will establish a blood donor screening process based on individual donor assessments, not sexual orientation. This change will promote the safety of America’s blood supply while making blood donation more inclusive, particularly for many in the LGBTQ+ community. The release of this final guidance is the next step in a lengthy evidence-based process of welcoming previously deferred individuals as blood donors. This new guidance will take time to implement and those impacted by these eligibility changes are encouraged to contact their local blood center to learn more.

“This shift toward individual donor assessments prioritizes the safety of America’s blood supply while treating all donors with the fairness and respect they deserve. The FDA’s final guidance is based on data showing the best protection against diseases like HIV is through strong testing of all blood donations and a uniform screening process for all donors. We are proud that America is now joining many nations around the world in changing our existing policies, which have historically stigmatized certain communities. It is important to note that these changes cannot be implemented overnight. We will continue working with our member blood centers to welcome impacted donors as quickly as possible,” said Kate Fry, Chief Executive Officer at America’s Blood Centers.

The FDA’s Transfusion Transmitted Infections Monitoring System (TTIMS) and the recent Assessing Donor Variability and New Concepts in Eligibility (ADVANCE) Study provided the data necessary to support that this change is safe.

As this change is announced, it is important for all Americans to remember the importance of blood donation. The COVID pandemic continues to disrupt many traditional school and work-based blood drives – the backbones of blood donation – resulting in critically low levels of available blood in many areas of the country. As a result, donations from individuals 19 and under have dropped nearly 50 percent over the last two years. ABC recently released a first of its kind guide showing that although a blood transfusion is needed every two seconds in the United States, just three percent of the U.S. population donates blood each year.

Founded in 1962, America’s Blood Centers is the national organization bringing together community-based, independent blood centers. Its member organizations operate more than 600 blood collection sites providing close to 60 percent of the U.S., and a quarter of the Canadian, blood supply. These blood centers serve more than 150 million people and provide blood products and services to more than 3,500 hospitals and healthcare facilities across North America. All ABC U.S. members are licensed and regulated by the U.S. Food and Drug Administration. For more information, visit www.AmericasBlood.org.

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    • Our Priorities
      • Strengthening the Blood Supply
      • Expanding Access to Blood Products
      • Moving Toward an Individual Donor Assessment
      • Diversifying the Donor Base
      • Eliminating Unnecessary and Duplicative Testing Requirements
      • Lowering the U.S. Platelet Content Requirement
      • Updating vCJD Guidance
      • Expanding the Availability of Blood in Hospice
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