Proposal ties financial incentives to development of drugs for neglected diseases

Abstract

Pharmaceutical firms that develop therapies for neglected diseases, like leishmaniasis, dengue fever, and Chagas’ disease, should be awarded an FDA voucher that would give the bearer priority-review status of another, potentially more profitable, drug, Duke University researchers proposed in an article published in the March/April issue of Health Affairs. Under the plan, the authors said, a company would receive a “priority-review voucher” from FDA in exchange for paying an additional $1 million in so-called user fees and agreeing to partner with at least one generic drug maker to develop a treatment for a neglected disease. The $1 million, the researchers estimated, would cover the personnel costs to FDA of changing a drug’s review status from standard, which generally takes 18 months, to a priority six-month review. The extra user fee, the researchers contended, would also ensure that the review process for other drugs in FDA’s queue would not be slowed.