P-QU-1 - A Call for Modernization of Biologics Licensing Process for Blood Centers

Blood centers operate under a regulatory framework designed to ensure the safety, potency, and efficacy of its blood products.  However, some of the current regulatory requirements may not fully reflect advances in technology or current best practices.  Having been implemented more than 80 years ago, the United States (US) Food and Drug Administration’s (FDA’s) biologics license application (BLA) process can present avoidable complexity and delay in providing patients with safe blood and blood products.  To better understand these challenges, a cross-functional working group of industry experts convened to identify root causes and explore opportunities to simplify and modernize licensing pathways for blood centers.

Study

Design/Methods:

Using a fishbone (Ishikawa) diagram, a working group analyzed licensing challenges experienced by blood centers across the country (Figure A). Contributing factors were categorized into four major areas: unclear requirements, lack of transparency, inconsistent regulatory interpretations, and lengthy timelines. Findings were compiled from institutional case studies, correspondence with the FDA, and comparative reviews of licensing timelines and regulatory responses.

Results/Findings:

FDA Form 356h, a required component of all BLAs, includes numerous fields irrelevant to blood products—leading to non-value-added activities that do not align with the Paperwork Reduction Act of 2024. FDA checklists are not consistently updated and provide lack of guidance on key advancements such as ISBT128 Standard. Inconsistent interpretation of regulations—for example, confusion over fixed vs. mobile sites or varying treatment of interstate vs. intrastate distribution—created disparities in access and potentially undermines the uniform safety and availability of the blood supply. Additionally, the process of implementing already approved collection and processing systems and devices remains overly complex, limiting flexibility, innovation, and responsiveness to operational needs.

Conclusions:

Licensing challenges have downstream impacts on timely access to safe blood products. When licensing processes delay the adoption of new technologies or restricts interstate resource sharing, patient care may be compromised. This analysis highlights practical, collaborative opportunities to enhance the BLA process, reduce unnecessary burdens, improve efficiency, and help ensure equitable, timely access to life-saving blood products across the US. The working group invites further discussion with the FDA and other stakeholders to explore shared mutually beneficial solutions.