FDA Fast-Track voucher system faces test

The US Food and Drug Administration's draft guidance document on tropical disease priority review vouchers (Marketletters passim) has been published in the Federal Register, providing details on how the scheme will operate. According to Kurt Karst, writing on the law firm Hyman, Phelps & McNamara's FDA Law Blog, it will soon be possible to evaluate the transferable voucher program's potential for success, with two possible early candidates: Swiss drug major Novartis' malaria drug Coartem (artemether, lumefantrine) and New Jersey, USA-based oncology specialist firm VioQuest Pharmaceuticals' Lenocta (sodium stibogluconate) for leishmaniasis.

The FDA expects five candidates per year to be awarded the voucher, which grants a priority drug review for a subsequent drug. It can be registered with another firm once only, but option trades would not be excluded, the agency said.