Why is the cost of colchicine in the United States high and manufacturers are very difficult?

What makes the cost of manufacturing colchicine increase the price of colchicine drugs? Colchicine had been sold at low cost for many years in the US. It is used to treat gout and is the primary treatment for a rare inflammatory disease called familial Mediterranean fever. Its availability on the US market predated the FDA’s regulatory authority to ensure the safety and effective use of prescription drugs, and many manufacturers made the drug, selling it for about $0.09 per pill.

In 2007, with the FDA’s encouragement, one of these manufacturers conducted a small clinical trial demonstrating the safety and efficacy of a short course of the drug in managing acute flares of gout. The FDA approved this Colchicine Manufacturer's version, granting sole market rights and ordering all unapproved versions off the market by January 2011. Exclusive rights for at least seven years were also granted for its use to treat familial Mediterranean fever, although no new studies were done on its effectiveness to treat this disease. The manufacturer of the new version, called Colcrys, sold the drug for about $5.00 per pill.

To gauge the impact of these market changes, Kesselheim and his colleagues conducted a retrospective cohort study of close to 217,000 insured patients. Between 2009 and 2012, these patients were all diagnosed with either gout or familial Mediterranean fever.

They found that the odds of a familial Mediterranean fever patient being prescribed colchicine within 30 days of receiving such a diagnosis dropped by 7.6 percent per month after the regulations were put in place, while the odds for gout sufferers dropped by 0.5 percent per month. They also found that average patients’ monthly total prescription bills rose from $418 to $651.

One of the FDA’s justifications for Colcrys’ approval was new warnings in Colcrys’ label about the lethal risks of co-prescribing colchicine with the antibiotic clarithromycin. But Kesselheim and his colleagues found no change in the rates of co-prescription of these two drugs, or co-prescription of colchicine with the transplant rejection medication cyclosporine, another deadly combination.

Drug regulation has made manufacturers pay more attention to the composition and effects of drugs, which makes the drug better, and when it increases the cost, manufacturers have to increase the price to recover the cost. It can be said that drug regulation has advantages and disadvantages for medical construction.