Rheumatoid Arthritis Support

As a drug predating the FDA, colchicine was sold as a generic in the United States for many years. In 2009, the FDA approved colchicine for gout flares, awarding Colcrys a three-year term of market exclusivity, prohibiting generic sales, and increasing the price of the drug from $9 to $485 per bottle.

Numerous consensus guidelines, and previous randomized controlled trials, concluded colchicine is effective for acute flares of gouty arthritis. But the FDA gave URL Pharma 3 years market exclusivity for its Colcrys brand, under the Waxman-Hatch Act, based on 2007 pharmacokinetic studies and RCT with 185 patients with acute gout. URL Pharma also got 7 years market exclusivity for Colcrys in treatment of familial Mediterranean fever, under the orphan drug act. URL Pharma raised the price from $0.09 per pill to $4.85, and sued to remove other versions from market. This will increase costs to state Medicaid programs from $1 million to $50 million. (Similarly, thalidomide approved in 1998 as an orphan drug for leprosy and in 2006 for multiple myeloma.)

In a critical editorial in the New England Journal of Medicine, Kesselheim and Solomon said that the rewards of this legislation are not calibrated to the quality or value of information produced. There is no evidence of meaningful improvement to public health. It would be much less expensive for the FDA or NIH to pay for trials themselves on widely available drugs such as colchicine. The burden falls primarily on patients or their insurers.


Adapted from the Wikipedia article Colchicine, under the G. N. U. Free Documentation License. Please also see http://en.wikipedia.org/wiki