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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 . . .

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