FDA To Increase Tropical Disease Priority Review User Fee Rate In 2016


Starting October 1, 2015, the FDA tropical disease priority review user fee rate is set to increase to $2,727,000, up nearly $200,000 from 2015’s rate of $2,562,000. Under the Prescription Drug User Fee Act (PDUFA) a priority review is intended to get drugs for qualifying tropical diseases (dengue, malaria, cholera, and Ebola) to market faster. FDA intends to review these products within six months of filing (compared to the standard ten months), and was granted the authority to determine and collect fees for these applications under the Food and Drug Administration Amendments Act of 2007. Sponsors wishing to use the priority review voucher must pay the FDA priority review user fee in addition to any other fees required.

The tropical disease priority review user fee rate is assessed and determined on an annual basis, and is “based on the difference between the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous fiscal year, and the average cost incurred by FDA in the review of a human drug application that is not subject to priority review in the previous fiscal year.” According to the Agency, the fee is used to cover the “incremental costs for FDA to do a priority review on a product that would otherwise get a standard review,” and allows it to have the necessary resources that are required to conduct a priority review.

Are you in the process of completing a submission for a tropical disease treatment? Are you looking to obtain priority review status? We can help with your FDA needs. Using our unique approach which combines vast scientific knowledge with extensive regulatory expertise, we have a solid track record of helping our clients achieve a successful outcome with FDA. We can help you too. To find out more about our services or to learn how we can help you, email us here.