[2008-05-06]
FDA to aid tropical disease research
By Andrew Jack in London

The Food and Drug Administration, the US regulator, is to unveil a pioneering mechanism this year that rewards pharmaceutical companies for their research into previously neglected diseases with vouchers for accelerated drug reviews.

These vouchers – highly valuable as they might speed up market access for new medicines – can then be sold on to other companies, which can use them for any drug.
The FDA is planning the launch of the “priority review vouchers” (PRVs) in August. The vouchers are designed to stimulate research into tropical ­diseases, for which there is little commercial market.

A company that wins FDA approval for a new medicine against diseases such as malaria, tuberculosis or dengue receives a voucher granting it a six-month review time by the FDA on another drug of its choice. Usually such reviews take 10-18 months.

There is no guarantee the FDA would approve the drug for which the PRV is used but by accelerating the launch of a potential “blockbuster” medicine by several months the mechanism might prove a powerful incentive, which some estimate could be worth up to $500m (£252m, €321m).

Large pharmaceutical companies, biotechnology groups and venture capitalists are supporting the idea of the vouchers.

However, there are concerns that the FDA has yet to clarify whether PRVs could only be sold on once, or whether it would boost their value even more by permitting further trading.

A recent article in the New England Journal of Medicine raised concerns about whether accelerated FDA reviews could result in safety problems.

There is some scepticism within the industry about whether the FDA could meet the PRV deadline of six months, given that its existing obligations for review periods often need to be extended.

PRVs were initially proposed in 2006 by researchers discussing ways to use market mechanisms to boost work on “neglected diseases” through making intellectual property laws more flexible.

David Ridley, an assistant professor at Duke University and the lead co-author, raised the idea with Senator Sam Brownback, who had been developing a proposal to stimulate research by extending the patent life of existing drugs.

But that sparked opposition from generic drug companies and consumer groups, which argued it would be unfair to allow continued high-priced monopolies beyond the original period.

Copyright The Financial Times Limited 2008



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