BPCA as a Model for Government-Sponsored Drug Repurposing

Drug repurposing can include the application of previously approved prescription drugs to new medical conditions and has been proposed as a lower-cost and less-risky approach to developing useful new treatments for patients, since widespread experience with a drug can help provide signals of potential activity and safety profile. There have been numerous examples of successful drug repurposing, such as thalidomide for multiple myeloma and colchicine for cardiovascular disease.

Despite the promise of the idea, there is concern that drug repurposing is under-used. Explanations include that drug repurposing provides little financial incentive for manufacturers to pursue such development, ¹ especially compared to the potentially lucrative market exclusivities associated with bringing new products to market.

One solution to help stimulate greater repurposing could be public funding of necessary clinical trials, such as through the National Institutes of Health (NIH). A successful legislative model for running such studies is the 409(i) provision of the Best Pharmaceuticals for Children Act (BPCA).