To treat gouty arthritis, patients have been taking a drug called Colchicine for over 200 years. Apparently, it’s a very helpful drug, but it’s neither new or innovative, to say the least. It’s no longer under patent protection and is available as a generic medication. It’s supposed to be super cheap, right?
So why is the estimated cash price for Colchicine .6mg at Walgreens about $590 for 100 pills?! Even with a Colchicine discount coupon it’s $239.37 – about $2.40 per pill. Compare that with the lowest cost Colchicine sold at a PharmacyChecker-verified international online pharmacy, 41 cents per pill or $41 for 100 pills – about 90% less than the Walgreens retail price! And just to be clear that’s a Canadian pharmacy price.
You can compare Colchicine prices at local U.S. pharmacies and international online pharmacies on PharmacyChecekr.com.com.
Yes, this is an example of drug companies AND U.S. pharmacies having free reign to charge whatever they want. For brand drugs on patent that often leads to exceedingly high prices because the pharmaceutical company has a monopoly: there’s no competition. But for generic drugs there is supposed to be competition to bring down the price. What went wrong with Colchicine?
The drug is so old that it predated the FDA-approval system of 1962 through which a pharmaceutical company must prove a drug is safe and effective before coming to market. It was one of thousands of drugs sold in U.S. pharmacies that were not FDA-approved. Then in 2007, the FDA took regulatory action to remove these unapproved drugs from U.S. pharmacy shelves.
There were good reasons for FDA to do so. There were drugs that were being marketed and sold for use by toddlers, such carbinoxamine-containing drugs, that may have resulted in deaths. The bottom line is that the FDA told pharmaceutical companies they had to apply to the FDA to sell their drugs or get them off the market.
In the case of Colchicine, there were many competitors in the market prior to FDA’s initiative. In 2009, URL Pharma’s branded version Colcrys was approved by FDA and given exclusive rights to sell Colchicine in the U.S. for seven years, longer than the normal three years, because the application was also approved as an Orphan drug to treat familial Mediterranean fever. Can you believe it? A seven-year monopoly on a drug in use for over 200 years. The price went from a dime per pill to $5 per pill – a 5000% increase.
Seven years later, generic drug competition is permitted and yet the price is still outrageously high. In 2014, FDA approved a competitor brand called Mitigare but the company that bought URL Pharma, Takeda sued the FDA for breaking its marketing exclusivity! Takeda lost the case.
In a legal brief from the American College of Rheumatology supporting market entry of Mitigare it was argued that gout patients were not taking their medications because of cost or seeking foreign treatments. Foreign treatments?! Did they mean lower prices in Canada? I’m glad they got their meds.
As of today: Colcrys (brand) sells for $867 for 100 pills; Mitigare $755; U.S. generic $239.37; the Canadian generic, via an international online pharmacy: $41.
That’s why the U.S. price is a rip-off. Any questions?Tagged with: colchicine