The U.S. Department of Health and Human Services (HHS) Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) met on January 11th to discuss and vote on blood supply sustainability recommendations to be proposed to HHS Secretary Xavier Becerra, JD regarding surge capacity for blood and blood products. America’s Blood Centers (ABC) had previously submitted comments to the committee in response to the proposed ACBTSA blood supply sustainability recommendations in June and November of 2023. Also, ABC and the blood community provided additional comments jointly to the committee in December 2023 supporting the proposed ACBTSA blood supply sustainability recommendations that government resources be made available to blood centers during national and regional emergencies.
During the ACBTSA meeting, the committee incorporated several of ABC’s recommendations regarding surge capacity for blood and blood products including:
- “that the HHS Office of Infectious Disease and HIV/AIDS Policy (OIDP) create a publicly available action plan that includes specific activities to safeguard the availability of blood; and indicates how the agency intends to implement coordination and collaboration with other federal entities, including the U.S. Food and Drug Administration (FDA);”
- that the HHS Secretary support additional public awareness campaigns with funding being distributed to blood collection agencies for local campaigns. The committee added that such “funding should also support data analytics to increase the donor pool and determine effectiveness.”
Additional proposed ACBTSA blood supply sustainability recommendations that the committee voted in favor of included:
- “the committee recommends that an HHS funding organization offer grant or contract funding that enables validation of existing products for extending the outdate of perishable materials used to manufacture blood or blood components. The Assistant Secretary of Health should identify the specific HHS funding organization entrusted with overseeing and implementing this endeavor;
- the committee recommends that HHS, including the FDA convene a multiorganizational working group, including suppliers, government agencies, and national experts from leading blood associations and organizations, to identify potential opportunities to pre-establish additional regulatory flexibility that could be granted in case of short- or long-term surge capacity needs to extend the U.S. blood supply. This analysis shall include an assessment of risks and burdens associated with the different temporary options.
- The actionable goals of this working group would be a list of suggested short-term changes to regulations that would be implemented only during emergencies when the necessary surge capacity could not be achieved in a timely manner without the implementation of some or all of these changes.”
The committee also discussed and agreed to form two working groups of the ACBTSA to continue revising and developing other recommendations regarding surge capacity for blood and blood products to propose to the HHS Secretary. Specifically, these working groups will address reimbursement issues regarding the functionality of the blood industry; and measures that can be taken during “extreme circumstances” to ensure the safety and availability of blood.
The full ACBTSA blood supply sustainability recommendations are expected to be published in the coming weeks. ABC will continue to provide updates regarding the ACBTSA recommendations on surge capacity for blood and blood products .