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New voucher program
May 11th, 2008
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FDA is expected to unveil a new voucher program that will reward drug companies for research into neglected diseases by accelerating drug reviews, the Financial Times reports.
The "priority review vouchers" will grant drug companies a six-month review period if they receive FDA approval for drugs to treat certain diseases, such as malaria and tuberculosis. These reviews usually take between 10 months and 18 months.
The vouchers are designed to stimulate research into tropical diseases, "for which there is little commercial market." They can be sold to other companies, which can use them for any drugs.
There is no guarantee that FDA will approve a drug that receives a PRV. However, by enabling a drug to be launched early vouchers, could be a "powerful incentive" for new research, the Times reports. According to some estimates, the vouchers could be worth up to $500000000.
The idea of the vouchers has received support from large pharmaceutical companies, groups and venture capitalists. However, "there are concerns" that FDA has not clarified whether PRVs can be sold only once or whether additional trading will increase their value.
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