The curious constraints on clofazimine

Clofazimine is a WHO-recommended therapy for multibacillary leprosy and an emerging option for drug-resistant tuberculosis and non-tuberculous mycobacterial infections. Yet in high-income countries like the USA, access remains restricted through expanded access pathways and other limitations, despite decades of safe use. This review examines clofazimine's regulatory trajectory in the USA, contrasts global access models, and highlights the consequences of relying on a single manufacturer and informal donation programmes. We argue that existing systems can be ill-suited to ensure equitable, sustainable access to essential but low-profit medicines like clofazimine. Policy options include simplified access pathways, WHO-based procurement for leprosy, and public manufacturing to stabilize supply. Clofazimine's case illustrates the need for proactive stewardship and access models that align with public health goals.