BLOOD Centers Act
The BLOOD Centers Act would require the U.S. Department of Health and Human Services, via the FDA Commissioner, to establish an expedited approval process for supplement applications to a biologics license (BLA) when a blood center wants to add an apheresis collection device to an existing BLA at a new location that has not previously been licensed for that device. The expedited process must be in place within 180 days of enactment and would aim to approve such supplements within 30 days of submission, unless there are safety/purity/potency concerns at the new site or a systemic failure related to the center’s other licensed locations. Eligibility for the expedited pathway hinges on the applicant already holding a BLA for at least one blood center site and meeting certain scale or accreditation criteria (3+ FDA-registered locations under the BLA, or accreditation in good standing with a recognized accrediting organization). In effect, the bill is designed to accelerate expansion of blood collection capabilities by allowing faster approval to add new apheresis devices at additional centers tied to an existing BLA, while maintaining usual safety considerations.
Key Points
- 1Expedited process required: By no later than 180 days after enactment, HHS/FDA must create an accelerated pathway for supplement approvals to add an apheresis collection device to an existing BLA at a new location not previously licensed for that device.
- 2Fast review timeline: Under the expedited process, the supplemental application must be approved within 30 days of submission unless safety/purity/potency concerns exist or there is a systemic failure at other licensed locations.
- 3Eligibility criteria: The applicant must hold a BLA for at least one blood center site and either:
- 4- have 3+ FDA-registered locations under the same BLA, or
- 5- be accredited and in good standing with an accrediting organization that meets or exceeds applicable regulatory standards for blood collection.
- 6Scope of the device addition: Applies specifically to adding an apheresis collection device to an existing BLA license at a location not previously licensed for such a device.
- 7Definitions: The bill provides definitions for BLA (biologics license application), blood center (human blood donation center), expedited procedure, and Secretary (the HHS Secretary acting through the FDA Commissioner).