Science and Development Network
News, views and information about science, technology and the developing world
Source: New England Journal of Medicine
18 November 2008 | EN | 中文
SciDev.Net/Tonks
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.
Add your comment
All comments are subject to approval and we reserve the right to edit comments containing inappropriate/unsuitable language. SciDev.Net holds copyright for all material posted on the website. Please see terms of use for further details.
You need to be signed in to post a comment or to email a consenting comment author. Please sign in or sign up.