Colchicine is now a branded gout drug, and why patients lose

Colchicine is a commonly used drug to treat gout. It used to cost pennies a pill, but now its price has since soared to $5 or more a pill.

What happened?

It’s an unintended consequence of FDA regulation. Colchicine had been used for centuries, but was caught up with the FDA’s zeal to regulate unapproved drugs.

A profit-driven pharmaceutical company swooped in at the opportunity, and performed the studies showing that the drug, of course, was safe. It then began selling it at markedly higher prices, and is suing the generic manufacturers for infringing on its branded drug.

Some of these manufacturers have stopped producing generic colchicine, while others have raised their prices.

The biggest loser, of course, are patients. What normally would cost $5 to $10 a month, now costs up to $150 monthly. It’s a ridiculous situation that can only happen in America.

There are three main ways to treat acute gout: colchicine, non-steroidal anti-inflammatories, and oral steroids. With colchcine’s cost being an issue, I suspect more physicians will switch to anti-inflammatories, which can be more dangerous than colchicine in select patients.

It will be interesting to see if other drug manufacturers will try the same approach with other old, previously unapproved, medications. It sure beats the expensive research and development needed to produce a new pill.

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  • http://thejobbingdoctor.blogspot.com the jobbing doctor

    What happened?

    Naked capitalism, I think!

  • Marc Gorayeb, MD

    “It’s an unintended consequence of FDA regulation.”
    This reveals the author’s bias. Loves the FDA and government regulation; hates evil drug companies for profiting from what is clearly an intended consequence of government over-regulation. The truth here is that this FDA policy of granting 3-year marketing exclusivity for conducting worthless “back-filling” studies of well-established drugs is a typical example of government zealots lording over and meddling in our lives. Another hidden tax has been revealed…

  • docguy

    wonder when it will happen with aspirin, maybe then the public will care otherwise unlikely for the general public to care at all.

  • http://drpullen.com Edward

    Agreed. An unintended, unwanted consequense of a dumb policy.

  • Rat

    I thought making money from someone’s misfortune is what medcine is all about.

  • ninguem

    The company that did this with Colchicine, as I recall, did the samt thing with quinine for those nocturnal leg cramps. Same price gouging as well.

    They brought nothing new to the table, at least nothing that’s worth the tenfold increase in price. They took advantage of certain misguided government policies, used “lawfare” for lack of a better word, to sue the generic manufacturers out of the business.

    I can’t necessarily blame the company, the FDA made this possible.

  • ninguem

    Here’s a recent WSJ article on the matter.

    http://online.wsj.com/article/SB10001424052748703630404575053303739829726.html

    And yes docguy, I can’t see any reason why they couldn’t do the same thing with aspirin, take a drug that you can get for a couple bucks a bottle, and make it ten dollars a pill.

  • http://notwithstandingblog.wordpress.com The Notwithstanding Blog

    It makes sense only in that a private company will want an incentive to take such a drug through the wringer of the FDA approval process, and the powers that be have chosen 3 year marketing exclusivity to be that incentive. I would think that a cash prize/bounty, or straight-out government funding of the trial would be a better option.

  • Marc

    Is this a patent protection? If so, what about prior art?

  • http://curbside.posterous.com Nuclear Fire

    @ Jobbing Doctor
    Naked capitalism? Did you even read the article? This happened because the FDA (government) decided to regulate everything rather than letting well enough alone. So now that a company has jumped through the hoops the government creates they have the power granted by the government to be the only maker of the drug. Naked capitalism was what we had before the FDA got involved. Naked capitalism was multiple companies making a drug in competition so the price was dirt cheap.

    Your biases are showing.

  • Dhanson

    Prevention by eliminated animal flesh in the diet is better than treating gout after it occurs.