To ensure patient access, and as we strive to meet the increased need for blood donations by opening new collection sites and adding new automation to existing sites, America’s Blood Centers is asking FDA to modernize the licensure process to ensure more rapid availability of blood components to all patients in need.
Modernizing the licensure process for blood centers will ensure blood and blood components are available when patients need them. The pandemic highlighted and accelerated the need to modernize the licensure process. During the pandemic, blood drive cancellations threatened the stability of the blood supply. To meet the needs of donors and hospital inventories, blood centers began to open new fixed-site locations and add automated collections to existing locations to adapt to these enduring changes. While accelerated by the pandemic, this move to more collections at fixed blood center collection facilities was a change that began before the pandemic and is likely to continue even as the pandemic wanes.
FDA provides guidelines specific to platelets collected by automated methods (i.e., by apheresis) and resuspended in plasma, referred to as “Platelets, Pheresis,” and includes requirements for reporting changes to an approved BLA specific to the manufacture of Platelets, Pheresis (also known as Apheresis Platelets). Additionally, FDA provides guidelines specific to collecting single and double units of Red Blood Cells (RBC) as well as collection of co-components by apheresis.
While collection of whole blood does not require additional licensure for a new location, blood centers currently may have to wait 12 months or more for blood and blood components collected by apheresis to be fully licensed by FDA. Additionally, blood centers struggle to provide the volume of quality control (QC) data recommended under the current apheresis platelets guidance, including two months of QC data. Until the blood center receives FDA approval, blood and blood components cannot be distributed across state lines where a need for blood and blood components may exist.
It simply means these products cannot be used to meet the needs of patients outside of the state, even though that is where they may be needed. Additionally, these blood centers are already licensed, and in most cases use the same lab to manufacture all of their blood products, as well as standard operating procedures that have already been approved by FDA. The safety history of the use of apheresis devices demonstrates that facilities can collect apheresis products at new fixed site locations without adversely impacting safety.
- Reclassify the reporting categories for the implementation of all types of apheresis product collections (RBC, platelets, and/or infrequent plasma) at new fixed site locations, provided that the primary facility is already approved for apheresis product they seek licensure for, from a major change to a minor change, requiring only a description in an annual report. An inspection by FDA should not be required as part of the submission. In the alternative,
- Reclassify the reporting categories for the implementation of all types of apheresis product collections (RBC, platelets, and/or infrequent plasma) from a major change to a moderate change, at new fixed site locations, provided that the primary facility is already approved for apheresis product they seek licensure for, without a requirement for an approved Comparability Protocol (CP), but instead requiring supplement submission at least 30 days prior to distribution of the product made using the change (CBE30). An inspection by FDA should not be required as part of the submission.
The COVID-19 pandemic has dramatically impacted the way blood and blood components are collected. As schools and workplaces moved to a virtual environment and/or limited who was allowed to be onsite, blood drive cancellations threatened the stability of the blood supply.
To meet the needs of donors and hospital inventories, blood centers began to open new fixed-site locations and add automated collections to existing locations to adapt to these enduring changes.
As blood centers strive to meet the increased need for blood donations by opening new collection sites and adding new automation to existing sites, this burdensome administrative process must be modernized to ensure more rapid availability of these additional blood components to all patients in need.
The Value of Blood
Learn more about the value of blood to the U.S. healthcare system through ABC's Value of Blood white paper. It examines the current resilience of the U.S. blood supply while highlighting areas that warrant further support.
Statistics & Research
Download ABC's U.S. Blood Donation Statistics and Public Messaging Guide, a first of its kind guide is designed to provide the latest look at America’s blood supply and its donors, including social media resources.
Letters and Comments
View the latest letters and comments from ABC as we work to advance our advocacy agenda, strengthen the blood supply, and support the important role of community blood centers across the nation.
2024 Advocacy Agenda
Promoting the value of blood to patients, communities, and the healthcare system.
America’s Blood Centers and our members are committed to addressing the challenges facing community blood centers that ensure a safe and available blood supply is always available to meet patient needs.
Through our Advocacy Agenda, America’s Blood Centers urges the Administration, Congress, and industry stakeholders to promote the value of blood to patients, communities, and the healthcare system.