America’s Blood Centers (ABC) submitted comments to the U.S. Department of Health and Human Services (HHS) Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA). The surge capacity comments to the HHS Advisory Committee were in response to the public comment period for the July meeting of the ACBTSA in which the advisory committee will discuss surge capacity for blood and blood products.
ABC stated in the surge capacity comments that “[i]t is important that surge capacity recognizes the vein-to-vein nature of blood donation, including donors, key manufacturing supplies, and hospital utilization. The COVID-19 pandemic strained all three of these areas and highlighted the need for robust public-private planning for future disaster scenarios, as well as flexibility in regulatory authority.” ABC described the importance of regulators “supporting a robust base of donors” explaining that “[l]essons learned from [the COVID-19 pandemic and the response of blood centers] should be discussed and memorialized to help shape the government and blood community response to future emergencies where a national surge in collection of blood product(s) is warranted.”
Additionally, the surge capacity comments to the HHS Advisory Committee referenced ongoing supply chain challenges that began during the COVID-19 pandemic. ABC emphasized that “[g]iven the fragility of today’s supply chain, it is imperative that strategic reserves of key supplies are supported by the federal government to ensure the safety and availability of blood products for hospitals and their patients moving forward. It is essential that the focus of ACBTSA action is on ensuring blood centers have the capacity to produce necessary blood products in the case of an emergency that justifies a surge in blood collection.”
Additional policy recommendations in ABC’s surge capacity comments included:
- “establishment of a vendor-management stockpile for key manufacturing supplies;
- inclusion of blood collection and blood collectors as part of the conversation during emergencies to ensure, where appropriate, blood centers are included as part of any effort to prioritize resources during a disaster;
- utilization of the U.S. Food and Drug Administration (FDA) regulatory flexibility related to blood and blood products during emergencies to support a safe and available blood supply;
- utilization of FDA regulatory flexibility related to reporting of supply chain challenges and licensure approvals during emergencies to support a safe and available blood supply; [and]
- [establishing] a public-private working group [to] evaluate disaster planning scenarios (e.g. biological warfare, nuclear detonation, blood transmissible pandemic) and the associated operational response for both the donor and supply side.”
The ACBTSA meeting will take place July 6-7th. ABC will continue to provide updates regarding its advocacy efforts as they become available.