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Colchicine’s Price Goes Through the Roof

We all hear about the new drugs that have just been approved, and we all keep track of the drugs that are coming off patent. But what about the really old ones, the drugs that made it to the market long before today’s regulatory framework? There have long been medicines that are generally recognized as reasonably safe and effective, but have never been through much of the modern process.
The FDA has, for the last few years, been trying to catch up on these things, and has offered exclusivity to any manufacturers who are willing to run clinical trials on older medicines. But this hasn’t always worked out the way that it was intended – witness the case of colchicine, a well-known natural product drug that’s used for some inflammatory diseases (and used to be a chemotherapy agent, too). The Wall Street Journal has a good story on this.
URL Pharma, a generic manufacturer, took the time and trouble to get fresh data on colchicine for gout attacks, and was granted a three-year marketing exclusivity period. So far, so good – but they then turned around and ran the price up by a factor of fifteen. They also filed suit against other small companies that were selling colchicine in the generic market, with the result that other domestic sources of the drug might dry up (four of the other companies are fighting back in court).
So is this the advent of evidence-based medicine, coming to an area that had little of it before, and therefore a good thing? Is it an abuse of the system by a company that saw an opportunity to suddenly acquire pricing power? Is it just what the FDA should have expected, given that three years of marketing rights have to make up for the cost of the clinical work, with the profits likely to disappear immediately afterwards? I think it’s going to be hard to have it both ways. If you expect companies to go back and fill in the clinical profile of older drugs, you do need give them some incentive to do it. But then what’s to keep them from pounding that incentive in good and hard, as seems to be happening here?
I’m not sure how to split that difference, especially not with any general rule, because each case will probably be different. The new clinical trials might, in fact, uncover something really useful that was previously unknown – or they might just confirm that the way the drug was being dosed was, in fact, just the way it should be dosed. One of those seems more deserving of compensation than the other, but there’s no way of knowing which result you’re going to get a priori. I have an aversion to telling a company how much it can charge for a drug, but it’s not like URL Pharma discovered colchicine, or had to do any of the risky early-stage work on it. I can justify some pricing moves (although not all of them) by companies that are doing discovery research, because so much of that doesn’t lead to anything marketable. (Take, for example, virtually everything I’ve worked on my whole career). But a generic company that’s coming in to dot the Is and cross the Ts on the FDA paperwork is something else again.
Perhaps if the FDA really feels that backfilling the regulatory work on drugs that no one owns in particular is important enough, they should fund the work themselves. But that opens up issues of its own, too.

55 comments on “Colchicine’s Price Goes Through the Roof”

  1. DN says:

    This was a bad result. We already knew colchicine had a narrow, often negative, therapeutic window, and that the toxic effects were of a severe nature. This is just graft at the expense of people with a severe disease. If Congress really cared about safety, they could simply fund the research directly and tax the drug to pay for it.

    1. DA says:

      Exactly what needs to be done. Why hasn’t anyone in congress come up with this simple, elegant and cost-saving solution ?

  2. Anon says:

    FDA is a regulatory agency. It implements laws passed by the Congress. If there was ever a case in which Congressional intervention is needed, this is it. As for FDA funding research, in the past it has let NIH do such work, and it makes sense for such work to remain at NIH. FDA has little expertise in research, and unfortunately, its record in drug safety is still pretty checkered. Up to now, the not-so-new-anymore Administration had performed OK in trying to reform FDA. This case suggests, however, that things are falling through the cracks yet again, and policy-formulation at FDA seems poorly operational at best. Where was the FDA request for action by Congress to close this loophole? Where was the referral by the Commissioner, who seems AWOL, to the Secretary of HHS for new legislation on the matter? There has been little action by the FDA once again, exactly when such action was needed. And we are all, literally, the poorer for it.

  3. Sili says:

    If Congress really cared about safety, they could simply fund the research directly and tax the drug to pay for it.

    1) They don’t.
    2) Higher taxes? In the US? AHAHAHAHAHAHAAHAHAHAAHaaaaaaaaaaaa

  4. J-bone says:

    Epic fail FDA.

  5. Hap says:

    Even before the bailouts and the large(r) deficits, taxes were going to have to be raised to cover the debts we’ve run up, not to mention SSI and Medicare/aid. Paying the same level of taxes for no services probably won’t fly, and you probably can’t get enough money from selectively hosing rich people to pay off the debt. At some point, people are going to stop funding us (the US) (via debt lending) or will demand Greece-like concessions to secure our debts. If we’re (the US) “too big to fail”, I’m sure that lots of other nations would like to make sure that we won’t have that card to play again. All of those scenarios will end up worse than voluntarily raising taxes and cutting spending (and changing entitlement benefits, starting with SSI) for us. Economic reality is an unforgiving Be****m, and it doesn’t care whether we are willing to listen or not.

  6. RM says:

    The problem is not that URL Pharma gets marketing exclusivity*, but that they’re using this to strong-arm other manufacturers. (* it’s reasonable trade-off for solid clinical trial data, since we make the same sort of bargin for new drugs)
    Correct me if I’m mistaken, but the marketing exclusivity was for treatment of gout, and gout only. All the other uses of colchicine (anti-inflammatory, chemotherapy, USP-grade supplies for research, etc.) are not covered. While URL Pharma has a right to pursue legal remedies against others selling it as gout treatment, my reading of the situation is that it has gone beyond that, claiming that *any* sale of colchicine could be infringing, as it can be used “off label” to treat gout. This, I think, is abusive and wrong.
    The problem, though, is that we do allow doctors to prescribe off-label. Once a physician knows that colchicine is a gout treatment, he’s perfectly free to prescribe any brand of colchicine, even if it can’t be marketed as a gout treatment. The “marketing exclusivity” isn’t really worth all that much. As we don’t want to ban doctors’ off-label option, we probably need a better incentive – unfortunately I can’t think of what could work.
    Probably the best bet is to get some division of the NIH (not the FDA) to fund clinical trials of these legacy drugs. Investigator-initiated is probably not going to cut it, though, so the NIH would likely need to push trials for desired drugs.

  7. MattF says:

    What if Medicare refuses to pay the higher price?

  8. Addi Faerber says:

    This is a great example of the interlinks between exclusivity, prices and marketing. URL Pharma isn’t just increasing the prices on their branded colchicine, but they are also marketing their product Colcrys (R) as a trademark branded drug. I havent’ seen television advertising for the product, but they have a website and print advertisements for physicians in medical journals.
    The manufacturer is granted exclusivity, brands the product, markets it as safer than “unapproved” colchicine, pushes competitors out of the market and jacks prices to increase their profits.
    Have you read this letter responding to the FDA’s actions to take “illegal unapproved colchicine products” off the market to enforce URL Pharma’s 3-year exclusivity?

  9. gwern says:

    > Is it just what the FDA should have expected, given that three years of marketing rights have to make up for the cost of the clinical work, with the profits likely to disappear immediately afterwards?
    No, it shouldn’t’ve expected it.
    If URL has the market power to make X millions, then it has the market power to make X millions. The length of exclusivity has little to do with it.
    What, are all the drug buyers thinking, ‘oh gee, you only have 3 years to recover your investment? I was only going to buy if the price was less than 5x the old price, but now I feel sorry for you and I’ll let you charge me 15x!’ Of course not.

  10. JP says:

    It is not the FDA’s job to worry about price. The FDA’s job is to ensure safe access to drugs. If someone comes along and cleans up an unregulated area with some data, then more power to them. There is no way the agency can allow other people to market unapproved drugs if there is an existing NDA.

  11. WT says:

    This rule is completely contrary to the spirit and letter of the Copyright Clause of the US Constitution. Not that Congress cares.

  12. TMac says:

    I take colchicine daily for a diagnosis of familial fever. It was announced my co-pay was jumping from $5 to $35. While it doesn’t crimp me personally, those without insurance are certainly going to pay for A LOT more for exclusive marketing rights. And for those of us with FF, this drug is a life saver — literally.

  13. Cartesian says:

    The price is growing because of the costs. But for some problems there are already some medicines (which could be generics), even if they are less efficient than what could be proposed ; so we have as well to be careful that some new medicines are not going to be delayed in order to reduce the cost, by waiting for example the death of some persons (who will not be paid). And I write this because it is a bit the feeling one can have about the work of some theoreticians (like for a new model of atom), that the validation process and the use of it are delayed in order to not pay as much. But it is a bit like slavery.

  14. Cartesian says:

    P.-S. : It is a bit like a tentative to subject intelligence.

  15. Vader says:

    One wonders what would have happened had FDA concluded, on the basis of the URL Pharma study, that colchicine was unsafe and must be pulled from the market.
    If that wasn’t a possibility, then what was the point of the study? No reason to reward URL Pharma.
    If that was a possibility, then of course URL Pharma would have lost the investment it risked on the study. But both URL Pharma and the other small companies marketing colchicine, which URL Pharma is now suing, would have lost their market. Seems to me URL Pharma was risking more than its own neck with this study, and perhaps should not reap all the rewards.

  16. john says:

    Figure a $20M – $30M clinical trial on a drug that sold $6M last year with a 5% profit margin, adjust for a 70+% risk that the drug fails to meet current FDA standards due to its modest TI, and then capitalize all the expenses at a VC hurdle rate of 70% or so.Throw in a 3 year exclusivity period and I’m surprised its only 15X.

  17. Anonymous says:

    Vader – you make an interesting point. If one company does a clinical trial and winds up having the drug pulled off the market, all the other companies selling that drug lose as well.
    Let’s turn the argument around. Why should companies that develop ‘me-too’ drugs get all of their profits? After all, it was some other company that paved the way, took all the risk and showed that a new mechanism worked in patients. What would Pfizer do if it had to hand over some of its statin profits.? That would spark some innovation in our drowning industry.
    I guess what strikes me is the hypocrisy I’m reading in these response to what URL did. The pharmaceutical industry rapes the patient every chance it gets and claims it’s because of all the R&D money they’ve invested. What a croc.

  18. RM says:

    One wonders what would have happened had FDA concluded … that colchicine was unsafe …
    If that wasn’t a possibility, then what was the point of the study?

    FDA clinical trials have two purposes: prove Safety and Effectiveness. e.g Vitamin C is safe (up to a certain point), but it can’t be (and shouldn’t be) sold as a treatment for AIDS until it’s been clinically proven to work against AIDS. Until then it’s snake oil. Even if colchicine is safe, that doesn’t mean that it’s effective for gout – even if it has been previously found safe and effective for inflammation.
    The knowledge that an existing drug is effective against a new condition is valuable, and also expensive to show – only Phase I is a pure “safety” clinical trial. Phase II and Phase III (where most of the clinical testing expense actually occurs) are both “effectiveness” stages. We *should* find a way to compensate those who spend time and money on clinical trials – either that, or move to a publicly-funded clinical trial model.

  19. Hap says:

    The problem with the generalization from colchicine to me-too drugs is that me-too’s generally aren’t the same. Unless the reason for a drug’s failure is directly related to its mechanism of action, me-too’s don’t threaten the drug from which they were derived. In addition, me-too’s generally have different benefits than their parents. And of course, you’ve still got to spend $1e9 on the me-too’s for them to get to market, just like the original drugs, so the original research doesn’t really represent a whole lot of the cost of getting the follow-on drugs to market.
    Another pretty theory ruined by dirty reality. Sorry.

  20. Sparr says:

    Abusing the pricing monopoly is a problem. Say there are 5 companies selling equal amounts of this old drug. The viable business model is to do the clinical trials IFF those trials cost less than the net profit you gain by taking over the other four companies sales for 3 years. That is, you currently make $1M/year, and so do they. Exclusivity is worth $4M/year to you (because you get to corner the markets previously held by your four competitors), so you do the trials if they cost less than $12M.

  21. 3+speckled says:

    Although the gouging will be costly in the short term, the company’s own research may cut costs in the long term. Their studies suggest decreasing by about half the amount of colchicine used in acute attacks of gout as well as in renal failure patients.

    1. Steve Becker says:

      Mathew Davis, You neglected to mention that of the money your company spent for this “research”, 50 million dollars of it was directly a payment to the FDA for the right capture a monopoly. What the public hates is the unholy marriage between the drug companies and the regulators. Both joining together to screw the taxpayer. This has to end!!!!

  22. Matthew Davis says:

    I enjoyed your thoughtful analysis. 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. The AGREE trial was a big step forward in understanding how colchicine should be used by doctors. The Colcrys dose we studied in AGREE was just as effective but far safer and more tolerable than high-dose colchicine. Among patients receiving the high-dose, 77 percent experienced diarrhea; the level of diarrhea in patients receiving the Colcrys was statistically no different than placebo. This discovery is, by itself, an enormous advancement for the health and safety of millions of patients who have commonly received unnecessarily toxic dosages of unapproved colchicine. Severe adverse reactions dropped from 19 percent in the high-dose group to zero in the group of patients receiving the Colcrys dose.

  23. nicole says:

    150.00 fora 3 months supply!!!!!! its freaking crazy!!!!!!!!!!! i cant afford that!!!!!!!

  24. NEJM says:

    The New England Journal of Medicine weighs in:

  25. NEJM says:

    The New England Journal of Medicine weighs in:

  26. Jo Ann S says:

    I take colchcicine for FMF, a hereditary illness
    that I have had since childhood. Since taking colchicine I have had no further attacks! It is proved to help those of us who have this ailment.
    I can’t afford the new pricing, what am I suppose to do? Sounds like a big con game to me!!!

  27. Garrett says:

    Speaking as a physician, this ruling by the FDA is a disaster for patients who take colchicine.
    The drug trial by the pharmaceutical company looked only at acute gout. The treatment course was very short and most patients had residual pain at the end of the treatment course.
    That’s the only clinical scenario the trial looked at. But that’s not how colchicine is usually used these days. Usually NSAIDS in high dose or prednisone are used for acute attacks in patients who can take these drugs.
    The most common use of colchicine currently is in low dose chronically. For example it is often used to suppress flareups when starting a patient on a drug like allopurinol which is used to prevent gout attacks. In this circumstance it often has to be taken in low dose (eg 0.6 mg once)daily for weeks if not months.
    Most physicians, I think, are aware of the toxicity of colchicine and know that dose modifications are essential in patients with certain common conditions.
    By forcing the “usual” colchicine off the market, the folks at URL are going to raise the cost of treatment by a factor of 10 or 15 making it prohibitively expensive.
    It is really aggravating that by doing a rather simple, very short term trial, using the drug in a way that it is not usually used any more, that the company can get this windfall. I am sure that if the FDA ruling stands they will more than recoup their investment. What’s next – aspirin? – another very old drug that could have the same thing happen.

  28. Thomas Hudson says:

    I really have a problem with this, to the point of considering legal action. I don’t take colchicine. I use it for my dog that has Shar Pei Fever.
    URL Pharma has no right to exclusivity for its use in dogs. I now pay $50 a month for something that used to cost $4 a month.

  29. anthony says:

    I usually pay $4 for 20 Colchicine.
    Now it’s $144.00 for 20.
    I don’t have insurance and I suffer monthly from Gout.
    What am I to do?
    Anyone who would do something like this should be shot.

  30. I own a Shar Pei. He has Shar Pei Fever, a fairly common disease in the breed. Untreated, this is a life threatening disease. The only treatment is colchicine twice a day. Current cost at our pharmacy is 34 cents per pill. ($20.40/month) The new drug is $5.00/pill; that is $300/month. This is a death sentence for my rescued pet. I also have gout and take a 5 day course of colchicine once a day for flareups. The cost of that will go from $1.70 to $30.00. I am retired on a fixed income. This price gouging is going to have a horrible effect.

  31. Jerry says:

    The FDA and Obama leading the idiots are now way out of line, After 40 years of daily colchicine, they decide to return the lobbyist favors and call the new BRAND the replacement ,,,,,I”m on medicare and a good part of my SS check will go to some pharmaceutical company that worked out this scam,
    We need a class action suit and now, Thiz is about the worst drug crazy action yet, And with the donut promises that obama has already broken,,,,,this makes it worse,

  32. tmn says:

    Yes, this is a situation that certainly cries out for the justice a class action lawsuit could offer. I’m beginning to explore the option now. Many have been injured by the needless, incredibly excessive greed of URL Pharma. Once begun, there will be publicity as to how injured parties can enjoin the suit…

  33. tcal says:

    I just purchased this drug in France for an acute attack of gout for 2.90 euro’s or about $4.00. This is an a very bad move by out government when they complain about the high cost of healthcare. They are the ones increasing healthcare costs with their stupid rules and regulations that do not really add protection to the health care system!

  34. Anonymous says:

    You can get colchicine from at least one of the overseas mailout pharmacies, for a MUCH lower cost. Local pharmacy was going to charge $154 for a 30-day supply of the only product remaining in this country. Get online and try that route.

  35. mike says:

    Guess what Obama did not do this, agreed stricken republican is responsible for this, as they are for the price of gasoline,If you believe the GOP
    drivel well , thats your misguided choice.

  36. Mike says:

    Time for round 2… Read about what KV Pharmaceutical is doing with “Makena”. Then do some google searches to review the criminal and administrative actions against them within the past 3 years.

  37. Kendrick Keeton says:

    Hi there Matthew Davis… thanks to people like you I cannot afford the one medicine that was helping me. I curse you and I hate you. I hope you live a long and and suffer much.

  38. Gary Sexton says:

    My feelings about Davis and the URL pharma is that they are a bunch of hacks who would not know how to do a clinical study on colchicine even if they had 50 years to practice (Take a template someone else made and fill in the blanks)? My gout attacks have NOT been alleviated with the “new guidlines” reccomended by the URL. Tried it, in pain for days until I upped the dosage. Am I to stay in bed crippled with swelling waiting for the “proper dosage” to begin to work? URL Pharma did not even develope a new drug. They don’t have the expertise to do that. So instead took advantage of flawed FDA regulations, and had what, a few weeks worth of study with 188 patients? Hardly thourough. Oh, and by the way my cost for colchicine, i.e. Colcrys, went up 2700%. Where was my insurance company Blue Cross/Blue Shield when this subject came up? Where was the FDA and our representatives in Congress? Everybody but URL Pharma gets hammered on this deal. US Tax payers, insurance companies, and me. If I’m asked to bend over could you at least supply a little vasaline?

  39. Gary says:

    I went to Wal-Mart to get my prescription filled. It was 500.00. That is not a typo. So, needless to say I am just having to suffer through tremendous pain because some jackass let URL Pharma rip everyone off. I didn’t ask for the drug to be tested, I have used it for over a decade, it worked fine.

  40. Sean O says:

    AH ! The wonders of expanded government regulation.

  41. Gary B. says:

    I agree with the other Gary posted on April 14. I too went to Walmart to get my refill to find out that my prescription price went through the roof and was going to cost me an arm and a leg. I’d gladly give my leg then I’d not be in pain. I too suffer through tremendous pain because URL Pharma jacked the price. Colchicine was working fine. Now I’m in pain and can’t afford my prescription. No thanks to URL Pharma. 🙁

  42. Jennifer C says:

    In 2005 I was diagnosed after 13 years of debilitating acute attacks (pain worse than child birth)with Familial Mediterranean Fever. I was prescribed Colchicine twice daily. I have been attack free (with the exception of two times when I missed more than two doses of my miracle Colchicine). I am one of only aprrox. 200,000 in the United States who HAS to take Colchicine for my quality of life as well as to save my life. (Amyloidosis of organs is a life threatening side effect of attacks)
    I am disgusted with this situation. I am terrified to go back to my life in hospitals, let alone the excruciating pain I experienced prior to colchicine. I am a mother of two (one who has special needs) and am going back to school. During these last 6 years (I am 36), I feel like I have really been able to “LIVE” my life. The people in our FMF internet group who have tried Colcrys have said it is not helpful to them. I will be running out of my Colchicine (West-Ward brand) in the next 6 weeks. I hope to find the Colchicine even in Canada if I have to.
    I am so scared.
    Why not keep Colchicine on the market for those of us who need it for life saving reasons?
    The greed of pharmeseutical companies in this country is sickening. How much does the Federal Government get from the price hike, I wonder.
    Jen C
    Familial Mediterranean Fever (k695r)

  43. iRate says:

    I just commiserated with a young fellow who suffered his first attack of gout. I described my attack, which woke me in the wee hours, thusly, “Three monster intruders hovered over me, one plunging the point of a broad sword into my big toe joint, another searing it with a blow torch, and yet another crushing it in a powerful vise. True story. Well, it sure seemed so.”
    I was unaware when I wrote him my advice that I was about to suffer a very long lasting gout attack… financial devastation. A senior living on Social Security, I simply will not be able to sustain this prophylaxis regimen.
    This outcome of the intent to provide the public with safer medications is being corrupted. Congress must immediately enact legislation to require full financial disclosure of all clinical studies, research and manufacturing costs, subject to oversight forensic accounting, and provide a proforma schedule for amortizing those costs. In other words, justify the retail pricing.
    Somehow this unseemliness reminds me of the fellow who just won a $2,000,000 lottery, but continues to fleece taxpayers paying for his groceries with food stamps.
    Our government seems to get dumber and dumber — or is it we who are the fools?

  44. shelly says:

    did you know that blue RX in their booklet lists it as a generic tier, but does not honor the drug in the program.Oboma should stub his ten toes.

  45. shelly says:

    did you know that blue RX in their booklet lists it as a generic tier, but does not honor the drug in the program.Oboma should stub his ten toes.

  46. Syrene says:

    I have a question: when has the FDA been created? Is it recent? What was the goal?

  47. Thom Grisso says:

    Today I went to get my Persciption filled and I get 180 pills .6mg they last me a year the price jumped from $90.00 to $1100.00 This is what happens when the FDA gives only one company permission to manufacture a generic drug I paid $36.00 for 180 Two years ago…. They are the only game in town….. Thank You FDA …Perhaps I should run aspirin through the FDA and get the sole right to produce a generic drug…. Bad Idea FDA

  48. darren says:

    Shame shame shame on the greedy, depriving the needs of stricken Americans. I am a veteran that is stricken with acute gout, and now the VA will no longer give me Colchicine due to the inflated cost. Colchicine is the only drug that can give me relief. I hope the fat cats at this horrible company burn in hell.

  49. Chuck says:

    I had my first gout attack back in the nineties and I started consuming colchicine for relief; it worked and that was way before the FDA got bought off and granted “a company” a license to charge monopoly prices for “approved” colchicine.
    Fortunately, I have a source of high-quality colchicine and can offer it for a lot less than the current ripoff price. Drop me a line at if interested. If not then either pay through the nose or do without it.

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