America’s Blood Centers (ABC), the Association for the Advancement of Blood & Biotherapies (AABB), and the American Red Cross (ARC) submitted public comments to the U.S. Department of Health and Human Services (HHS) Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) regarding blood supply sustainability. Specifically, the comments are in response to additional recommendations related to sustainability of the U.S. blood supply during national emergencies proposed by the ACBTSA. In the joint comments on blood supply sustainability, the blood community expressed their support for recommendations that government resources are made available to blood centers during national and regional emergencies.
Additionally, the three organizations endorsed the recommendation that the Zika payment model be used during long-term emergencies to support the collection and manufacture of blood components to allow for a minimum 10 percent increase over baseline usage during emergencies when surge capacity is required. However, the blood community also, “encourage[d] expansion of the model to ensure blood establishments are not collecting blood at risk and are receiving necessary financial support through cost recovery funding, similar to the collection and distribution of COVID-19 convalescent plasma (CCP); and establish[ing] funding for local public awareness about the need for blood donors.”
The comments on blood supply sustainability from the blood community emphasized that the, “best use of any future federal funding for public awareness for blood donation is best directed locally.” Specifically, ABC, AABB, and ARC explained that it is, “essential that the U.S. government invest in local funding for blood establishments to use in increasing awareness of blood donation, especially among diverse, young, and newly eligible individuals.”
Other blood supply surge capacity recommendations proposed by the blood community regarding blood supply sustainability to the ACBTSA included:
- “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);”
- specifically identifying HHS funding agencies that companies providing “critical supplies for blood manufacturing and storage shall work [with] to develop and enact contingency plans to stabilize the blood supply chain;”
- requesting that the “ACBTSA also recommend that the Assistant Secretary of Health recommend that the Administration for Strategic Preparedness and Response (ASPR) elucidate its role in stabilizing the blood supply chain and revise its policies pertaining to Medical Countermeasures (MCMs) to ensure the availability of essential items, including but not limited to, blood bags, saline, reagents, pipettes and other critical components necessary for maintaining a secure and adequate blood sup-ply;”
- identify the specific HHS funding organizations who can “offer grant or contract funding that enables the development of novel means for extending the outdate of perishable materials in the stockpile; [and] specify which agencies within HHS are responsible for advancing strategies to extend the shelf life of perishable materials;”
- • the blood community’s comments regarding blood supply sustainability to the ACBTSA also suggested, “that HHS, including the FDA, work to convene a multi-organizational working group, including 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 without impacting the safety, purity, or potency of blood donation. This analysis shall include an assessment of risks and burden[s] associated with the different temporary options;” and include actionable goals and anticipated outcomes.
ABC, AABB, and ARC concluded the comments with recommendations regarding blood supply surge capacity:
- “establishment of a baseline inventory of blood;
- modeling of unprecedented emergency scenarios; and
- funding for a sustained increase in blood inventories.”
The ACBTSA will hold its next meeting on January 11th to discuss blood supply surge capacity and vote on the blood supply sustainability recommendations. ABC previously submitted comments in response to blood supply surge capacity recommendations from the ACBTSA in November and June of 2023.