BLOOD Centers Act

Full Title:
BLOOD Centers Act

Summary#

This bill directs the Secretary of Health and Human Services, through the FDA Commissioner, to set up an expedited process for approving certain supplements to biologics license applications (BLAs) for blood centers. The Secretary must create the process within 180 days. Under the process, a supplement to add an apheresis collection device at a location not previously licensed would generally be approved within 30 days after submission unless the Secretary identifies a specific safety, purity, or potency concern for the location or a systemic failure by the operator at other licensed locations. The expedited route applies only to owners or operators that already hold a biologics license for at least one blood center site and either (1) have been approved for that license at three or more FDA-registered locations, or (2) are accredited and in good standing by an accreditation organization whose standards the Secretary determines meet or exceed applicable regulatory requirements.

What it means for you#

  • If you run or manage a blood center that meets the bill's criteria, you could add an apheresis collection device at a new, previously unlicensed location and expect an FDA response within about 30 days unless safety or compliance problems are identified.
  • The Secretary has 180 days to set up the expedited process after the bill becomes law.
  • The FDA may delay or deny approval for specific safety, purity, or potency concerns at the new location or for systemic failures by the operator at other sites.
  • Blood centers that do not meet the listed criteria (fewer approved locations and not accredited as required) would not qualify for this expedited pathway.

Expenses#

No publicly available information on costs or budget effects is provided in the bill text or accompanying metadata.

Proponents' View#

No publicly available information about sponsors' statements beyond the bill text and short title. The bill text and short title indicate an intent to create a faster approval process to add apheresis devices and to open donation centers more quickly.

Opponents' View#

No publicly available information on opponents' views is included in the bill text or metadata.