Experience with the Priority Review Voucher Program for Drug Development

Through August 2015, the FDA had issued 6 priority review vouchers—3 for neglected tropical diseases and 3 for rare pediatric diseases—but several vouchers were awarded for drugs that were already approved abroad, based on previously conducted trials, or associated with safety signals, while vouchers were sold for up to $350 million each. The authors detail how the program’s design has allowed companies to earn substantial financial rewards without necessarily conducting new research, suggesting that the voucher program may not be achieving its goal of incentivizing novel drug development for neglected diseases.