There have been no FDA-approved or designated treatments for Chagas disease since 1983. That’s more than 25 years. Diseases like Chagas, which are relatively uncommon in America (but affect a large part of the global population), are considered rare by the FDA and drugs, vaccines, and diagnostics targeting them are termed “orphan,” because biotechnology and pharmaceutical companies are not interested in owning or producing these treatments. So how do we create systems that ensure more funding for Chagas and other neglected diseases of the developing world?

Last Friday, this very question was debated at the Tufts Center for the Study of Drug Development’s forum, “Neglected Diseases in the Developing World.” During the forum, representatives from the FDA, NIH, USAID, developing country governments, non-profit organizations, and leading academic institutions discussed how to incentivize drug development and ensure that new drugs, technologies, and information make it to people who need them.

Among different strategies to encourage research and product development for neglected diseases, Tim Coté, Director of the Office of Orphan Product Development at the FDA, highlighted and strongly endorsed the priority review voucher (PRV) program. This program awards a voucher to a company that develops a drug or vaccine that targets a neglected disease. The voucher can be “cashed in” for use with a future product of the company’s choosing. It makes that future product eligible for a “priority” review—a process that is generally 4-10 months shorter than a standard review, but is no less rigorous. The benefit of the program is that earlier market entry of the future drug will allow for longer market exclusivity and possible gains that come from beating competing drugs to market.

Sixteen diseases currently define the list of qualified neglected diseases. This list has been debated, and the FDA held a public comment meeting in December 2008 asking for suggestions for expanding the list. Chagas disease – which is not on the current list – was recommended by BVGH for inclusion during this time.

We will continue to advocate for Chagas’ inclusion, but in the meantime it is important to show that the PRV program works. And for the program to truly act as an incentive, the economic benefit to the company has to be as big as possible. To a drug company with development costs exceeding hundreds of millions of dollars, the larger the windfall, the better the incentive. Only a huge success will truly convince drug companies to invest in new research and development for diseases of the developing world.

To learn more about PRVs, please visit BVGH’s Web site on the program: prvinfo.org.

Anna Heard is the Director of Policy and Advocacy at BVGH.