Sarcouncil Journal of Biomedical Sciences

Abstract: Despite the growing number of therapies receiving regulatory approval from the U.S. Food and Drug Administration, ensuring timely patient access to innovative oncology treatments remains a significant challenge. This qualitative systematic review synthesizes evidence from 20 studies to examine policy and system-level constraints that delay patient access to FDA-approved oncology therapies in the United States. The review identifies five interconnected categories of barriers: regulatory governance and approval processes, health system infrastructure and institutional capacity, pharmaceutical supply chain vulnerabilities, socioeconomic and geographic disparities, and clinical implementation challenges. Findings indicate that these barriers rarely operate in isolation. Regulatory and reimbursement delays cascade into clinical implementation bottlenecks, infrastructure gaps compound supply chain vulnerabilities, and socioeconomic disparities amplify constraints at every stage of the access pathway. The review concludes that fragmented policy interventions targeting individual barriers are insufficient. Improving timely and equitable access to oncology therapies requires coordinated reforms that align regulatory efficiency with reimbursement processes, strengthen infrastructure alongside supply chain resilience, and embed equity monitoring across all stages of the access pathway.