Will Aspirin Become the Next Epipen?

Aspirin is grandfathered from all the FDA silliness, right?  That's what I thought until this:

But if the FDA gets its way, nitroglycerin will not be obtainable for pennies. The situation was stable until Pfizer went through the time and expense required to test its particular version of nitroglycerin, Nitrostat, which the FDA approved in 2000. Once the FDA did that, other versions became officially "unapproved." In 2010, the FDA sent warning letters to two companies, Glenmark and Konec, ordering them to cease marketing their versions of nitroglycerin, known as sublingual nitroglycerin tablets, leading to the New York Times headline above. The article quotes Dr. Harry M. Lever, a cardiologist at the Cleveland Clinic, who said, "If it's not approved and no one has tested it, we can't be sure that it's safe and effective." He added that if patients with angina took substandard or ineffective nitroglycerin tablets, their pain might not subside and the problem could potentially progress to a heart attack.

His statement is false. The unapproved versions have been tested in three important ways: the companies that manufacture these drugs thoroughly vet them to make sure that they are pure and offer a consistent dose of nitroglycerin; these marketed drugs have been tested in the bodies of millions of Americans in regular medical practice over many years; and many different organizations have tested nitroglycerin in countless clinical trials.

I can't think of anything about the situation in nitroglycerin that doesn't obtain for aspirin.  By this, all it would take would be for one company to have the cojones and cash to get FDA approval for their aspirin and they might be able to wield a monopoly.


  1. HenryBowman419:

    Similar events have transpired before, courtesy of the FDA. Levothyroxine, which has been used to treat hypothyroidism since the 1930s, was never approved by the FDA prior to its marketing, for obvious reasons. Then, a company went ahead and got it approved, and the price trebled.

    Is there anything the FDA cannot screw up?

  2. Rick Caird:

    Once again, the FDA is on track to kill more people than they save. The FDA is a net negative organization and needs to be put to sleep.

  3. Matthew Slyfield:

    "Is there anything the FDA cannot screw up?"

    Railroads? On second thought, the FDA is a government agency. If they decide to screw up railroads, they will find a way.

  4. J_W_W:

    I think we should switch the assumption that the FDA Is good to a base assumption that they are actually evil....

  5. Matthew Slyfield:

    No, even that is giving them too much credit.

  6. McThag:

    I wonder if there's not a relation to the assault on GRAS items to this sudden urge to get certified.

  7. jdgalt:

    The FDA has its problems (and its tougher approval process, which resulted from the thalidomide scandal, was a CYA move by bureaucrats that needs to be overturned pronto).

    But in the main this is not an FDA problem. The problem is patent trolls and their lobbyists.

  8. ddb:

    So, no regulatory oversight, Ricky.. tell us your plan to oversee big pharma..

  9. sch:

    Other examples include colchicine, going from $0.5-0.10 per pill to $5 each. Relatively small market for this
    as it is mainly used for acute gout and there are other treatments. Generic albuterol inhalers wafted away
    when the feds decided the carrier pressurizer for the spray bottles was toxic to the ozone layer and mandated
    a change. Net result was 6-10x increase in price for the inhalers. (ref: coyotes favorite idiot: http://www.motherjones.com/kevin-drum/2013/10/heres-why-your-asthma-inhaler-costs-so-damn-much) To say nothing of the price of doxycycline,
    formerly pennies, now up 40-60x because of sole sourcing and limitations on ability of Indian manufacturers to
    get licensed. Doxy is the preferred antibiotic for all tick borne infections among others. Digoxin would be in this
    category but is rarely used these days compared to 20-30 yrs ago.

  10. sch:

    I forgot to mention the somewhat ridiculous price differentials for nitrospray vs the sublingual pill, and that was before
    coyote's discussion above.

  11. Matthew Slyfield:

    Nope, not what he said. There is a hell of a lot of room between the FDA as it is now doing more harm than good and zero regulation. It isn't a binary choice.

  12. Darkness Dragon:

    It's bound to happen when you let the system hold a monopoly on regulating what's good and harmful for you to use.

  13. TMallory:

    The problem is that the FDA has not been a government funded agency in 30 years. They are funded by the fees they charge for drug testing. They are also exempt from conflict of interest, because they say all the best people, that they need to hire, come from the pharmaceutical industry. After watching then shamelessly shill during the early days of E-cigarettes, I lost all respect for them. They are not regulators, only protectors of the drug companies who pay them.

  14. CapitalistRoader:

    The FDA and patent trolls and manufacturer lobbyists are one, gigantic problem. There's an organization serving the revolving door between the FDA and drug/device companies called the Food and Drug Administration Alumni Association. They say it's not a lobbying organization but looking at their mission it's even more damaging to consumers:

    The Association's core mission is to help alumni stay in touch with the issues of the day facing the FDA and support the agency's public health mission through expertise- and experience-sharing, training and outreach opportunities. Membership is open to the thousands of FDA alumni and current employees nationwide.

    Translated: ...help former FDA employees who are now employed by drug/device mfgr's set FDA policy in their employers' favor.

    Woodrow Wilson warned about this over 100 years ago:

    If the government is to tell big business men how to run their business, then don’t you see that big business men have to get closer to the government even than they are now? Don’t you see that they must capture the government, in order not to be restrained too much by it? Must capture the government? They have already captured it. Are you going to invite those inside to stay? They don’t have to get there. They are there.
    The New Freedom: A Call For the Emancipation of the Generous Energies of a People (1913)

  15. SamWah:

    If so, Bayer will sue, Sue, SUE!

  16. BobSykes:

    Bayer has a monopoly on aspirin in Germany, and it is quite expensive there.

  17. David in Michigan:

    "The article quotes Dr. Harry M. Lever, a cardiologist....."

    I checked on this guy and he is in fact a reputable cardiologist. Since I am in agreement with the reasons stated in the post as to the FDA's overreach (i.e., this is not a new drug and has been successfully used for a 100 years by millions of patients), I am wondering why Dr. Lever would make such a nonsensical statement. What am I missing here or what is the article missing?

  18. morganovich:

    did you check to see if either he or the cleveland clinic are in bed with pfizer in some way?

    he who pays the piper calls the tune.

    is he doing or has he done a pfizer drug trial (perhaps for nitrostat?)?

    is he on an "advisory board" for something similar?

    i'm just spitballing here, but the first thing i would try to look for is some conflict of interest.

  19. David in Michigan:

    I'm going to have to disagree on the thyroxine price allegation. I have had to use thyroxine since 2009
    and I can tell you for a fact that generic L-thyroxine is cheap ..... $15.00 for 90 day supply. It is true that the FDA did become involved with its manufacture and did require certain certifications as to potency and shelf live but that's all to the good in my opinion. This is for synthetic L-thyroxine. As to naturally derived thyroxine (generally from pigs), I can't address that issue as it is more complicated.

  20. ddb:

    Nope, I'm pretty sure that's Ricky's 'opinion'..

  21. Agammamon:

    The main problem is the FDA. Patent trolls and their lobbyists have nothing to do with this. The people making EpiPen are not patent trolls. This isn't even a patent issue - its an FDA licensing issue. Patents are exclusionary, FDA licenses are not.

    Next you'll be calling them kulaks and wreckers because they just won't do what their betters *intended* them to do instead of what they were told to do.

    If 'Work To Rule' can screw up your business, you need to seriously re-think your rules.

  22. Jerry_In_Detroit:

    What we're seeing is the monetization of administrative law. In this case, the FDA has a list of drugs that were grandfathered into the original Food and Drug Act. The FDA has decided that these drugs must now go through the current testing process. As a result, many old drugs which still work but are also not very profitable, have been driven from the market with drug manufacturers all too happy to supply more expensive alternatives.

  23. CC:

    Aspirin can be obtained from the bark of the willow tree. The ancient greeks knew about it. It is one of the oldest effective remedies known.

  24. SamWah:


  25. DaveK:

    Not quite aspirin... Willow bark is loaded with salicylic acid, which is a precursor chemical to aspirin (acetylsalicylic acid). A dose of salicylic acid strong enough for pain and fever relief is likely to cause a bit of gastric discomfort. Aspirin is much more effective and causes far less gastric irritation.

  26. DaveK:

    You know, they've performed such miracles with AMTRAK. What could possibly go wrong?

  27. Matthew Slyfield:

    Well, yeah, but that's not the FDA.

  28. DaveK:

    You're right. I just used that as an example of how the government could screw things up and call it a success.

  29. Matthew Slyfield:

    I was saying that if they really tried, the FDA could fine a way to screw up railroads.

  30. Georgfelis:

    (checks with Google)
    Pfizer donated between 1-5m to the Clinton Foundation in 2009 alone.
    The FDA makes a decision that vastly benefits Pfizer in 2010.
    I wonder if there's a connection.
    Naa, I don't wonder.