July 25, 2017, Vol 318, No. 4, Pages 313-400
Association of the Priority Review Voucher With Neglected Tropical Disease Drug and Vaccine Development
Nina Jain, MD, MSc; Thomas Hwang, AB; Jessica M. Franklin, PhD; et al.
JAMA. 2017;318(4):388-389. doi:10.1001/jama.2017.7467
Congress created the priority review voucher in 2007 to incentivize the development of treatments for neglected tropical diseases. Vouchers, which can be transferred or sold, are awarded when a company obtains US Food and Drug Administration (FDA) approval for a drug or vaccine indicated for a neglected tropical disease (Box). They allow sponsors to obtain faster FDA review of a product for any indication, not restricted to neglected tropical diseases, moving the application from the standard 10 months to the priority review timeline of 6 months. This provides valuable earlier access to the US market for those drugs that would have not otherwise qualified for priority review: vouchers have been sold for prices ranging from $67 million to $350 million.2