US FDA Review Vouchers criticized

The US Food and Drug Administration's recently-launched program for encouraging drugmakers to present new medicines for neglected diseases that affect people in poorer countries has come under criticism from Aaron Kesselheim, a member of the pharmacoepideniology and pharmacoeconomic faculty at Brigham and Women's Hospital, Massachusetts, writing in the New England Journal of Medicine, with claims that the scheme will not achieve its stated goals. September saw the launch of the priority-review voucher given to a drugmaker to be used on a future drug in exchange for developing a product for diseases such as tuberculosis or leishmaniasis (Marketletters passim). Under the scheme, a specialist drug firm can generate additional revenue by selling its vouchers for use by potential blockbuster drug manufacturers, under section 1102 of the FDA Amendments Act of 2007.

The voucher addresses a clear demand for R&D in neglected tropical diseases, however, Dr Kesselheim argues that it should give way to less market-driven schemes, such as R&D being carried out exclusively by government research centers and non-profit agencies, or a prize fund to compensate winning proposals, based on their ability to generate actual health outcomes improvements.

Voucher "offers no incentive" for improvements