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.
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