Fast track drugs for poor countries21st August 2008
The United States has announced a prize system to encourage the development of treatments for diseases that disproportionately affect patients in developing countries.
Drug developers that register a vaccine or medicine combating a tropical disease could be eligible for the "Priority Review" vouchers, entitling them to get their drug fast-tracked through the approvals process.
The Priority Review process is normally reserved for particular drugs that satisfy a strict set of conditions, and takes about six months compared with the usual 10 for a drug to be approved in the US.
Faster approvals mean drugs can reach the market quickly. Some analysts estimate that the vouchers could effectively make companies an extra US$300 million.
Vouchers can also be transferred or sold on to other companies that might want their own drugs to be approved more quickly, boosting the value of the vouchers and providing even more incentive for research into neglected diseases.
The voucher system came into force on 27 September 2007, and will begin to be issued one year after that date.
The diseases and conditions on the list include sleeping sickness, malaria, tuberculosis, leprosy and cholera.
The US also provides for 'minority' drugs under the Orphan Drugs Act which is usually use to incentivise drug productions for diseases affecting less than 200,000 US citizens.
The scheme includes research and development (R&D) tax credits and a waiver of the FDA’s user fee, and seven years of marketing exclusivity once approved, compared with five years of exclusivity for other drugs.
But experts say some questions remain, including the question of how often the Priority Review vouchers may be traded, crucial if a market in the vouchers is to be built.
Also, active ingredients in drugs applying for the voucher must not have been repeated in other drugs, which would mean drugs which are later found to be effective in the treatment of diseases affecting poorer countries would be excluded.
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Title: Fast track drugs for poor countries
Author: Luisetta Mudie
Article Id: 7943
Date Added: 21st Aug 2008