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  • Priority review vouchers might not be the way forward

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Priority review vouchers distributed by the US Food and Drug Administration (FDA) must be tied to implementation programs if they are to improve global health, says Aaron Kesselheim.

The new program gives sponsors of drugs for tropical diseases accelerated approval for their other, more profitable drugs — such as anti-depressants — aimed at the wealthier world.

But these vouchers are an inefficient, potentially dangerous way of encouraging research into tropical diseases, says Kesselheim. There is no incentive for companies to follow through with implementing therapy, and intellectual property rights might render the drug unaffordable for developing countries.

Hurried approvals could also lead to bad regulatory decision making by the FDA, says Kesselheim.

A better option would be to set up independent funds to compensate companies for treatment implementation programs, based on the degree of success in controlling the disease in question.

Alternatively, governments could work with not-for-profit foundations to develop treatments for neglected diseases, which could then be licensed to for-profit companies for dissemination, suggests Kesselheim.

Link to full article in New England Journal of Medicine

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