The Food and Drug Administration (FDA) provides oversight of America's blood supply. FDA policies do not allow certain individuals to donate blood based on the potential for risk to the safety of the blood supply, known as a deferral. Changes in scientific knowledge, data, and technology – such as pathogen reduction technology or improved tests – have led to the FDA making recent donor deferral changes that impact hundreds of thousands of individuals who were previously unable to donate blood, including:

• Removal of the indefinite deferral for risk of exposure to Mad Cow disease (bovine spongiform encephalopathy)
• A draft guidance moving away from a prohibiting gay and bisexual men from donating blood and towards a personal risk assessment for all donors

When FDA changes to donor eligibility occur, blood centers must undertake extensive changes before welcoming back impacted donors:

• Updating the Donor History Questionnaire (DHQ) that determines an individual’s eligibility to donate. Any updates to the DHQ requires FDA approval and can take months to complete. Until the DHQ is approved, blood centers cannot implement the new FDA policies.
• Blood centers must update their Blood Establishment Computer Software (BECS) and validate the changes to ensure all information is entered to allow all blood products to be properly tracked and labeled. This software manages all blood components and related data to ensure a safe and reliable blood supply.
• Center operations, including Standard Operating Procedures (SOPs), must be updated, and staff must be trained on these changes.
• Informational and educational materials must be updated to reflect the changes.

These FDA changes come at a critical time for the blood supply when inventories remain critically low. While blood centers are already working with community organizations such as veterans’ organizations (since many of those donors deferred for risk of exposure to vCJD are either military or veterans and their families) and LGBTQ+ organizations., these efforts are constrained by a lack of funding.

Federal funding directed locally has shown to generate significant results in the recruitment of first-time and repeat blood donors. During the collection of COVID-19 Convalescent Plasma (CCP), funding was provided through an Other Transaction Authority (OTA) to increase the total number of CCP collections. America’s Blood Centers (ABC) managed the program and distributed funds to 37 not-for-profit blood centers, resulting in a 244% increase in CCP collection in a 20 week period, ensuring CCP was available for patient needs during the delta wave of COVID-19 when few therapeutics were available.

To reach as many impacted donors as possible, America’s Blood Centers is asking Congress to provide targeted federal funding that can be used locally by blood centers to amplify their education and awareness efforts.

Speakers include:

Peter Marks M.D., PhD.: Director of Center for Biologics Evaluation and Research, Food and Drug Administration

Benjamin Brooks, JD, MPH: Associate Director of Policy and Education, Whitman-Walker Institute

Allie Van Dyke: Strategic Partnerships & Programs Manager at The Blood Connection

Diane Calmus, JD: Senior Director of Federal Government Affairs at America’s Blood Centers

You can stream the virtual event here. 

Become a social media advocate on this important issue. Download and use these free pre-sized social media images to spread the word. Be sure to use the hashtags #BloodAdvocacy and #WhyBlood.

Ask Congress to Support Funding to Promote Awareness of New Eligibility Criteria for Blood Donors