Global health vouchers: Round 2

When the FDA Amendments Act of 2007 (FDAAA) became law last September, it included a largely unnoticed mechanism to encourage development of treatments for tropical diseases: Priority Review vouchers. To get the system off the ground, FDA, companies and global health advocates now have to haggle through important functional details. And while stakeholders expect the program to speed the development of compounds that are already fairly derisked, they told BioCentury more incentives are needed to spur real upstream innovation.

Under the statute, sponsors of drugs that are approved to treat diseases that primarily afflict residents of developing countries will be eligible to receive a Priority Review voucher. The vouchers, which can be traded or sold, entitle the bearer to obtain a Priority Review of any subsequent NDA or BLA...