Regulatory pharmacy strategies for reducing drug development costs in underserved population

Abstract

The rising costs of drug development present a critical challenge, particularly for underserved populations, who often struggle to access essential medicines. This paper examines several regulatory strategies to reduce these costs, such as adaptive regulatory frameworks, incentives for orphan drug development, leveraging real-world evidence (RWE), public-private partnerships (PPPs), and promoting generic drug development. These strategies offer pathways to balance innovation with affordability, thereby addressing health disparities.