America’s Blood Centers (ABC) strongly supports the recent Food and Drug Administration (FDA) Final Guidance on Alternative Procedures for Cold-Stored Platelets and the ongoing analysis related to this important blood product. This guidance allows for extended use of cold-stored platelets from 3 to 14 days, a critical step forward in safely promoting increased availability and utilization of platelets for patients in need.
ABC has been a longtime advocate for this change, raising the need for an increased shelf-life for cold-stored platelets to the attention of the FDA at the 2019 FDA Blood Products Advisory Committee (BPAC) meeting. As part of our Advocacy Agenda, ABC has advocated for FDA approval of an extended shelf life for cold-stored platelets as a way to address the emergent need for platelet availability for certain patient populations across the United States. Cold-stored platelets are an important answer in the treatment of actively bleeding patients in instances when conventional platelets are unavailable, or their use is not practical.
Additionally, ABC is pleased that the Biomedical Advanced Research and Development Authority (BARDA) is engaged in further study, with support from multiple blood centers, of additional usage for cold-stored platelets through the CHIlled Platelet Study (CHIPS).
ABC and its member blood centers stand ready to continue to work with FDA, BARDA, and others to gather the research and data required to continue to advance the availability and utilization of this important blood product.