Bipartisan BLOOD Centers Act Aims to Streamline Opening of New Blood Centers

Congressman Tony Wied (R-Wisc.) and Congresswoman Kim Schrier (D-Wash.) recently introduced bipartisan legislation designed to boost the nation’s blood supply by making it easier to open new blood centers.

If enacted, the Boosting Lifesaving Operations, Opening Donation (BLOOD) Centers Act would require the Food and Drug Administration to establish an expedited supplemental biologics license application (BLA) process for blood centers that already hold three BLA licenses or have at least one BLA-licensed location with an industry accreditation exceeding FDA standards. The legislation would require that FDA approve the supplemental application within 30 days unless there are significant safety or compliance concerns.

Under existing FDA regulations, blood centers that collect blood via apheresis at fixed physical locations must submit a supplement to their BLA for each new collection site to distribute products across state lines. This licensing process often requires extensive documentation and review, even when the new site operates under the same standard operating procedures, staff and equipment as the licensed facility.

As a result, approval times may extend beyond one year, creating operational inefficiency and delay access to critically needed blood products. The BLOOD Centers Act seeks to streamline this process and help centers respond more quickly to patient demand.