FDA To Unveil ‘Priority Review’ Vouchers for Neglected Disease Research
FDA in August 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.
According to the Times, 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 drug, the Times reports.
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 $500 million.
The idea of the vouchers has received support from some large pharmaceutical companies, biotechnology 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, the Times reports (Jack, Financial Times, 5/1). This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
