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For all its rhetoric about advancing human health, the drug industry has never shown much interest in tropical diseases that kill or plague millions of people, for the very simple reason that poor nations can’t pay top dollar for new drugs. That may be changing, though, thanks to a new federal program that rewards companies who get drugs approved for malaria, tuberculosis and similar undertreated diseases.
What’s fascinating and potentially disturbing about this program, though, is the fact that the reward consists of a transferable FDA “priority review” for a new drug. At first, this seems like a no-lose proposition — the priority review doesn’t seem to cost the government anything, and it could be worth $300 million or more to the companies involved, since priority review cuts the length of FDA review to six months from an average of 18 months (at least in theory).
On the other hand, the list of currently marketed drugs plagued with safety problems or concerns about their efficacy just keeps growing, and at least one serious study suggests that the drugs approved most quickly are also most prone to serious side effects. So this tradeoff could be a dangerous one.
There’s also the fact that while handing out addtional priority reviews doesn’t seem to cost the FDA anything, it does disadvantage other companies waiting for the agency to review their drugs. It’s not as though FDA’s new-drug office has unlimited time and attention, after all, so giving someone a free pass to the front of the line inevitably slows up everything for those further back.
(Hat tip: the In Vivo Blog)
Image of spilled pills via Flickr user e-magic, CC 2.0
posted by David P. Hamilton
July 17, 2008 @ 6:11 am
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