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With FDA Approval, a Gout Drug Now Costs $5 Instead of Pennies

Posted Apr 12 2010 3:25pm

The recent history of a medicine used to treat gout provides another chapter in the book of unintended consequences. We’ll recount some highlights of the tale as spelled out in this morning’s WSJ:

A common gout drug, colchicine, has been around for so long that pre-dated the FDA and until last year, it had never been approved by the agency. As part of a push by the FDA to bring such drugs under its umbrella, a company called URL Pharma commissioned studies to show that colchicine was safe and effective, and last summer the FDA approved the company’s version and gave URL three years of marketing exclusivity for the drug.

Here come the unintended consequences. While the FDA says it hoped there wouldn’t be a significant run-up in the price of colchicine — sold as Colcrys by URL — the retail cost has soared to more than $5 a bill from the previous pennies a tablet. URL Pharma also sued five makers of manufacturers of colchicine, saying they have been illegally marketing their colchicine products since Colcrys’s approval. One of those makers has settled the matter and stopped production. The other four companies are fighting the lawsuit.

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