Improving clozapine utilization will require continued advocacy, drug sponsor interest, and FDA support to address REMS issues.

Significant research and clinical efforts have improved the safety of clozapine since FDA approval. In the US, the Clozapine Risk Evaluation and Mitigation Strategy (REMS), implemented to ensure completion of hematologic monitoring, remains a major barrier to clozapine use. The FDA has the authority to modify the Clozapine REMS, the largest perceived barrier to increasing clozapine utilization. [Extracted from the article]