Defining the Priority Review marketplace

In its new draft guidance on Priority Review vouchers for tropical diseases, FDA may have allayed concerns that it would implement the mandate in a way that would discourage use of the vouchers. The document signals the agency's willingness to accept arrangements that would allow the rights to use a voucher - if not the voucher itself - to pass through multiple hands.

When the FDA Amendments Act of 2007 became law last September, it included a mechanism to encourage development of treatments for tropical diseases. First proposed by a group of academics in Health Affairs in 2006, the idea was to offer sponsors of drugs for these neglected diseases a voucher that could be exchanged for Priority Review of a subsequent BLA or NDA that otherwise would not qualify (see BioCentury, July 21)...