Comment on “Implementing standard practices in the safe handling of gene therapy and biohazardous drugs in a health-system setting”

We read with great interest the study by Wang et al,1 which examined the implementation of infrastructure and a standard operating procedure (SOP) for gene therapy drug handling in a large integrated health system. This effort represents an important advancement in institutional biosafety and acknowledges the evolving complexity of biological drug therapies in pharmacy practice. The authors should be commended for addressing a significant regulatory and procedural void by creating a new biohazard risk classification and aligning workflows across departments. Structured interprofessional collaboration, facility risk assessment, and comprehensive SOP design are noteworthy strengths that would support reproducible implementation of this protocol in other large academic centers. However, the manuscript leaves two critical questions unanswered, both of which have clinical and operational implications. First, the authors introduced a new medication classification without providing outcome data evaluating whether staff interpret the label consistently or whether its introduction alters downstream clinical behavior, such as by causing delay or refusal of therapy administration by nursing. Without such data, there is a risk of overclassification, leading to workflow inefficiencies or inappropriate escalation of safety precautions, particularly when the true infectious risk of replication-deficient viral vectors remains largely theoretical.2