US voucher system to boost tropical disease drugs
The United States is set to launch a prize system to encourage pharmaceutical companies to develop drugs for tropical diseases.
Sixteen tropical diseases, including sleeping sickness, leprosy and malaria are listed as eligible for the scheme.
Under the system, companies producing a drug or vaccine for a tropical disease can apply for a Priority Review voucher, which allows them a shorter approval time for another drug at a later date.
The shorter approval process would take approximately six months instead of ten, meaning that drugs could hit the market sooner and potentially be more lucrative. Thus, the vouchers are estimated to be worth around US$300 million.
Companies can also take advantage of the Orphan Drugs Act, under which drug developers receive tax credits, a waiver of the US Food and Drug Administration's user fee and seven years market exclusivity on drugs that have no economic viability.
The first vouchers can be legally issued from 27 September 2008.
But the wording of the voucher law needs tightening up, say commentators, and some aspects — such as a rule stating that drugs can't contain active ingredients that have been approved in another application — could restrict eligibility.
The Food and Drug Administration is currently drawing up guidelines on how the law will work in practice.