ABC Statement on FDA’s Changes to Donor Eligibility Criteria During COVID-19 Pandemic (April 3, 2020)
America’s Blood Centers and its members are committed to maintaining a safe and available blood supply and treating all potential donors with fairness, equality, and respect. We commend the U.S. Food and Drug Administration (FDA) for their continued support during this unprecedented situation as our nation coordinates response efforts to COVID-19.
In recognizing the need to maintain an adequate blood supply during the COVID-19 pandemic, the FDA has evaluated and modified current policies regarding the eligibility of certain previously deferred donors. The changes are based on data from new studies showing these changes can safely expand the nation’s blood supply. ABC supports these changes, which include shortened deferral periods for individuals at higher risk of HIV, including men who have sex with men (MSM), and individuals receiving recent blood transfusions, accidental blood exposures, tattoos and piercings. FDA also finalized guidance on Creutzfeldt–Jakob disease (CJD) and variant CJD which will make eligible individuals who spent time in numerous European countries or on military bases in Europe. ABC continues to support donor eligibility requirements founded on scientifically based data about donor and transfusion safety and individual behaviors.
The FDA’s actions will allow for the re-entry of thousands of individuals to the donor pool who were previously deferred. While these changes are approved during the emergency declaration for COVID-19, the FDA believes the recommendations should continue after and intends to revise and replace these guidance documents with updated guidance that incorporates any comments received. They have committed to doing this within 60 days after the emergency declaration ends. Blood centers will be actively working to implement the FDA-announced changes. This will take time as blood centers are diligently working to change and adapt their policies and computer systems to reflect these changes, which must be implemented in a controlled environment in accordance with good manufacturing practices.
Individuals are strongly encouraged to contact their local blood center to confirm the implementation timeline, their eligibility, and to schedule appointments to donate. While the blood supply is currently stable, there will be an ongoing need for blood donation throughout the pandemic and beyond.
Download this release here.