On September 29, the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) held a roundtable, “Strengthening the Supply Chain for Blood Manufacturing.” The roundtable convened FDA leaders, blood collection industry representatives, manufacturers, and other Department of Health and Human Services (HHS) agencies. Participants discussed ongoing supply chain challenges and strategies to improve supply chain resilience and reduce the likelihood of disruptions to blood manufacturing operations.
Overview of the roundtable discussions
During the meeting, presenters highlighted the need to strengthen the resilience of the blood manufacturing supply chain and reduce reliance on reactive shortage management. Key themes included:
- Maintaining backup supplies of critical materials;
- Enhancing preparedness for disruptions such as cybersecurity incidents;
- Investing in supply chain resilience through multiple sourcing and quality systems; and
- Improving communication and coordination among industry, regulators, and government partners.
Participants also emphasized the importance of recognizing blood as an essential medicine.
Kate Fry, Chief Executive Officer of America’s Blood Centers (ABC), urged “that community blood centers continue to have a seat at the table for managing issues along the supply chain. She added that ABC “stands ready to partner with FDA, HHS, and industry.” In closing remarks, Anne Eder, MD, PhD, Director of CBER’s Office of Blood Research and Review (OBRR), called the meeting “a first conversation in strengthening the blood manufacturing supply chain. Because it’s so crucial to healthcare in the U.S.”
ABC views the blood supply as a national asset
The themes raised at the roundtable reflect the core ABC position that the blood supply is a national asset. In a forthcoming white paper, ABC offers four key policy recommendations to strengthen the nation’s blood supply resilience:
- Align Federal Policy with Blood’s Essential Status. Recognize blood as critical healthcare infrastructure and incorporate blood supply resilience into national preparedness, emergency management, and healthcare security strategies.
- Fund the Blood Resilience Investment Framework. Create dedicated funding in support of preparedness and resilience initiatives across the blood ecosystem.
- Implement a National Blood Donor Resilience Initiative. Establish dedicated funding that can be used locally by blood centers in support of donor recruitment, retention, and emergency readiness.
- Implement Existing Federal Recommendations. Advance the recommendations contained in the HHS Adequacy of the National Blood Supply: Report to Congress (2020), including real-time monitoring risk modeling, and sustainable financing.
ABC looks forward to continued engagement with FDA, other HHS agencies, manufacturers, and blood industry stakeholders to strengthen the blood manufacturing supply chain and advance national blood resilience.
Access the full written comments from ABC CEO Kate Fry here.