America’s Blood Centers (ABC) submitted written comments to the U.S. Food and Drug Administration’s (FDA) Blood Products Advisory Committee (BPAC) ahead of the April 26th meeting encouraging the agency to modernize the licensure process for blood centers. The FDA BPAC comments explained that there is “an immediate need to modernize the licensure process for blood centers [and that doing so] will ensure blood and blood components are available when patients need them.” This is a priority outlined in the 2023 ABC Advocacy Agenda.
The comments recommended that the FDA:
- “reclassify the reporting categories for the implementation of all types of apheresis product collections (red blood cells (RBC), platelets, and/or infrequent plasma) at new fixed site locations, provided that the primary facility is already approved for [the] apheresis product they seek licensure for, from a major change to a minor change, requiring only a description in an annual report (21 CFR 601(12(d)). 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 [the] 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) (21 CFT 601.12(c)). An inspection by FDA should not be required as part of the submission.”
The FDA BPAC comments were based on the “pandemic highlight[ing] and accelerating the need to modernize the licensure process.” The comments also detailed how blood centers “began to open new fixed site locations and add[ed] automated collections to existing locations to [adapt].” They explained that “[w]hile 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.”