REGULATORY UPDATE: Blood Community Requests Extended CCP EUA Enforcement Discretion Period

November 13, 2020

AABB, America’s Blood Centers (ABC) and the American Red Cross (ARC) requested that the Food and Drug Administration allow for additional time for an effective transition to the new labeling requirements for emergency use authorization (EUA) COVID-19 convalescent plasma (CCP) units as either high- or low-titer, as well as to distribute current stockpile units of investigational CCP. In a Nov. 2 letter, AABB, ABC and ARC asked FDA to extend its enforcement discretion until March 2021.

The letter noted the blood community’s commitment to the national effort to support the collection and distribution of CCP, in partnership with the Department of Health and Human Services (HHS), FDA and the Biomedical Advanced Research and Development Authority (BARDA). The organizations reiterated their appreciation for the urgency around the EUA’s implementation and their continued support of CCP as a bridge therapy, providing potentially life-saving treatment for critically ill patients until additional therapies become available.

The joint letter outlines the organizations’ specific requests and the contributing factors, which are largely outside the control of blood centers and hospital transfusion services. It also suggests an approach that would ensure CCP remains readily available to patients during this transition to the EUA while additional antibody testing options become available and alternative treatment options continue to be limited.

FDA is currently considering the extension request. Members with questions may contact regulatory@aabb.org.