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.
The tale of how this common gout drug, colchicine, became the costlier branded drug Colcrys offers a window into the Byzantine world of drug pricing. The price rise is a consequence of a Food and Drug Administration effort to improve the safety of long-used but unapproved drugs, with a trade-off often made between drug affordability and safety.
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.
4 comments:
My name is Matthew Davis, M.D. I am the Chief Medical Officer of URL Pharma. I personally ran the 17 clinical trials that lead to the FDA approval of Colcrys. The FDA has repeatedly and publically called for the manufacturers of unapproved colchicine to bring colchicine into FDA compliance and up to modern regulatory and scientific standards. As per the FDA, only URL Pharma “has chosen to take the clinically responsible step of seeking approval for unapproved oral colchicine.” We have spent millions of dollars, and enormous effort, that has resulted in our discoveries that greatly improve the safe use of colchicine through our Colcrys formulation, AGREE trial results, and many other studies. The manufacturers of unapproved colchicine have not conducted even one clinical study.
Thank you Dr Davis.
Now explain how you decided on the price of Colcrys.
I appreciate Dr. Davis' post, but I suspect he wasn't involved in deciding the price of the medication. That's done by people who run calculations in a different department, and it goes something like: Divide the "Total cost to the US economy of Not Treating The Disease" by "The # of People who have the Disease", then divide that by "The # of doses likely to be taken to control the disease" over some span of time. Then you run the outcome past some focus groups... say an HMO rep or someone in the EU Health Economics department... and that's your IDEAL price. Since the other alternative drugs are so cheap, you'll have to scale back a bit to retain your market, but you get the basic idea.
I quit a job once because I couldn't stand being in the business of making a simple thing more expensive simply because the market would "have" to chuck up the money or else.....
I'm not buying into the Dr. Davis's "argument." According to the folks at the New England Journal of Medicine, the research that got the exclusivity approval from the FDA involved ONE WEEK of blind tests which included less than 200 people suffering from an acute gout attack in the tested group. Millions in research to get the approval? Don't think so. I'd love to see the info on EVERY one of those 17 clinical trials and the actual costs. Sounds like a whole lot of puffing.
One suspects that some very sharp money boys URL Pharma spotted the gigantic loophole in this rather stupid law and drove a truck through it -- allowing what amounts to 3yr/7yr price fixing which would otherwise be an anti-trust violation for conducting a very modest controlled trial that "confirmed" the efficacy and safety of a drug with a 2000+ year history and which has been used in the US for over a century and which most anyone with gout knows works well and which has been known for centuries to have toxic effects if used to excess.
This strikes me as about as scientifically significant as discovering that the sun comes up every morning and can cause sunburn -- something well known to the ancients.
Have you been working on an exclusivity right on aspirin too.
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