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News/Event Item
Drug Development for Neglected Diseases - The Trouble with FDA Review Vouchers
Nov. 6, 2008
September 2008 marked the beginning of a new federal program intended to promote the development of pharmaceutical products for so-called neglected diseases — infectious diseases that disproportionately affect poor populations in developing countries. Implemented by the Food and Drug Administration (FDA) Amendments Act of 2007, this program will give the sponsor of a drug for a tropical disease a "voucher" entitling the company to expedited FDA review of a new drug application for any other product it makes.
The need to encourage additional research in this field is clear. Diseases such as tuberculosis, malaria, leishmaniasis, and trypanosomiasis affect millions of people each year, but these people live primarily in resource-poor settings with underdeveloped health care systems. As a result, the for-profit pharmaceutical industry has invested little in treatments for these conditions. One study found that of the 1393 new chemical entities marketed between 1975 and 1999, only 16 were for such diseases.
The new program links the development of drugs targeting tropical diseases to accelerated approval of a company's other, more profitable drugs for conditions prevalent in wealthier countries. A voucher obtained after the approval of a drug for a tropical disease can be used to require accelerated regulatory review (in 6 months or less) of a cholesterol-lowering drug or an antidepressant, for example, that the sponsor might sell in the United States for thousands of dollars per year of treatment. According to the arrangement's proponents, vouchers could speed up FDA evaluation time by an average of 12 months, providing domestic patients with more rapid access to the latter types of drugs. A voucher could be worth more than $300 million, thanks to the earlier period of market exclusivity afforded by decreasing the time a drug spends in FDA review.
© 2008 Massachusetts Medical Society
For full article, visit:
http://content.nejm.org/cgi/content/full/359/19/1981
category: News from Other Sources : General Health News
contributed by Liza Nanni on 20 November 2008
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