Last month, the FDA granted its eighth priority review voucher (see Table 1). These transferable vouchers can be sold or used at the FDA to secure a priority review of a drug, and are intended to encourage drug developers to work on neglected tropical diseases and rare paediatric indications. An analysis of the first six vouchers found little evidence that the vouchers were achieving their public health aims.

Table 1 Priority review vouchers to date
Full size table

Aaron Kesselheim, of Harvard Medical School, and his colleagues found that the vouchers were awarded to drugs that had been shown to be effective in the clinic and sometimes approved outside the United States years before they were filed with the FDA (JAMA 314, 1687–1688; 2015). In some cases drug development had depended on significant public sector investment, raising the question of whether the right group was being rewarded. “One way to potentially prevent such windfalls would be to redesign the voucher system so that drug companies would have to show some level of investment,” the authors write.

The FDA's Office of New Drugs Director John Jenkins recently told Pharma&MedTech Business Intelligence that the agency has concerns about these vouchers and noted that a voucher-triggered review can be “very challenging and has the adverse impact of requiring managers and reviewers to refocus time and resources away from other important public health work”.