REGULATORY UPDATE: AABB, ABC, ARC Submit Joint Comments on HBsAg Testing

AABB, America’s Blood Centers (ABC) and the American Red Cross (ARC) submitted joint comments Sept. 26 in response to the Food and Drug Administration’s draft guidance, “Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen.” Developed by a subgroup of AABB’s Transfusion-Transmitted Diseases (TTD) Committee, the comments reflect the shared priorities of the blood community.

The joint comments commend FDA’s responsiveness to the blood community's 2022 joint letter, which advocated for the removal of HBsAg testing for transfusion-related donations when HBV NAT and anti-HBc testing are performed. AABB, ABC and ARC believe this marks a significant step toward aligning donor screening practices with current scientific evidence-based regulatory requirements.

However, the continued requirement for HBsAg testing of source plasma, despite the proven reliability of HBV NAT and the widespread use of pathogen inactivation (PI) technologies, creates a regulatory inconsistency and diminishes the practical impact of the draft guidance. AABB, ABC and ARC cautioned that the differential treatment of source plasma versus recovered plasma complicates fractionator acceptance and impedes harmonization efforts.

The organizations emphasized that recent scientific evidence and modeling from Héma-Québec demonstrate that HBV NAT, when paired with pathogen inactivation (PI), provides a robust safety margin for all plasma-derived medicinal products. The joint comments urge FDA to eliminate HBsAg testing requirements across all plasma types, recognizing HBV NAT and PI as sufficient safeguards. The blood community believes that harmonizing U.S. standards with international practices would reduce unnecessary testing and support global consistency.