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FDA grants monopoly on folk remedy

by EdHannigan / April 13, 2010 7:29 AM PDT
An Old Gout Drug Gets New Life and a New Price, Riling Patients

A centuries-old drug used to treat excruciating gout pain had cost just pennies a tablet?until last year. Now, the retail price has skyrocketed to more than $5 and some of the manufacturers have ceased production amid a battle over marketing rights.

In July 2009, a Philadelphia drug maker received FDA approval to exclusively market colchicine for gout attacks for three years. The company, URL Pharma Inc., was taking advantage of a push to bring medicines predating the FDA, like colchicine, under the agency's regulatory umbrella. The FDA offers exclusive marketing rights if a drug maker conducts clinical trials.

URL Pharma had commissioned studies that confirmed its colchicine product's safety and efficacy, while demonstrating it should be taken at a lower dose than typical and not used with certain other medicines. The company is marketing its drug as Colcrys?and the retail cost averages $5 per pill, according to DestinationRx, a health-care data provider.

URL is also suing longtime manufacturers of unapproved colchicine, saying the companies are now illegally marketing their products. Some of the companies are fighting the lawsuits. Some themselves have raised prices?including one increase of just under a dollar per tablet to $1.17, according to DestinationRx. The higher price for Colcrys was first reported by Kaiser Health News.
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What next, Granny Clampett's rheumtiz medicine?
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