Section 1102 of the Food and Drug Administration Amendments Act of 2007 (P.L. 110-85) created an FDA priority review program for new drug applications for tropical diseases such as malaria and cholera. The law requires the FDA to act within six months of receipt of these applications. The agency gives “priority review vouchers” to sponsors of products for tropical diseases. The vouchers are transferable. A new Senate bill introduced on June 18, 2008, by Senator Sherrod Brown (D-Ohio) would increase the transferability of these vouchers. Instead of merely permitting the transfer of vouchers from a sponsor to another sponsor, the bill would generally permit all transfers, including sales. The bill provides, however, that no voucher may be redeemed to affect the review of a pending human drug application.
SOURCE: S. 3151, 110th Cong., 2d Sess (2008)
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