As I discovered while revising Rosen's new chapter on arthritis emergencies, the price of colchicine, an ancient gout treatment, has gone way up lately -- while suggested regimens for treating gout have recently changed. These are not unrelated, and the connection is actually quite interesting. You see, colchicine was grandfathered-in as an approved therapy by the FDA at its inception in 1938. Its safety and efficacy were never formally reviewed by the FDA...
...until 2009, when URL Pharma submitted the results of their new trial to the FDA, showing comparable efficacy and somewhat improved safety to high-dose colchicine regimens, using a simple 1.2 mg dose followed by a 0.6 mg chaser an hour later.
The FDA, bound by Hatch-Waxman exclusivity, considered this a new indication for colchicine, and responded by granting 3 years of market exclusivity to URL Pharma. The price of colchicine (now called Colcrys) subsequently shot up from 9 cents a pill to $4.85 -- though if you read the drug company's site, they make it sound like they're doing patients a favor, protecting them from unapproved forms of the drug that worked well enough, for decades.
I appreciate the way the authors of this NEJM opinion piece considered this state of affairs:
It seems reasonable to expect that costly new drugs or increases in drug prices would be accompanied by a substantial benefit in disease management to be enjoyed by these patients. This standard is not met by Colcrys; in this instance, the public may bear considerable costs for a poorly executed administrative goal.Yep. A few US Senators sent URL Pharma a strongly-worded letter this past spring, but I don't think anything came of it (you can't say the company's done anything illegal, and our society is well past the point where we can expect corporations to act in any interest but their own).
I'll just be interested to see what happens in August 2012, when the 3-year exclusivity period should end and colchicine prices return to, hopefully, to a less painful place.