FDA Review Vouchers

To the Editor: In his Perspective article, Kesselheim (Nov. 6 issue) 1 expresses concern about priority-review vouchers for drugs for the treatment of neglected tropical diseases. We proposed the voucher program in 2006, 2 it became law in 2007, and the law allows vouchers to be awarded by the Food and Drug Administration (FDA) in 2009. 2 Under the law, developers of treatments for neglected diseases such as malaria and tuberculosis are rewarded with priority-review vouchers to be applied to other drugs, such as profitable cardiovascular therapies. Kesselheim says that this prize system is “potentially dangerous” and “inefficient,” and he suggests that it . . .