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posted by on Sunday February 12 2017, @06:39AM   Printer-friendly
from the patent-trolls-by-another-name dept.

Dr. Derek Lowe, from In the Pipeline, writes:

So since drug pricing and FDA regulations are so much in the news, it would seem like the perfect time for a small company to game the system for big profits, right? That's apparently what Marathon Pharmaceuticals believes. They just got approval for deflazacort, a steroid, as a treatment for Duchenne Muscular Dystrophy.

[...] So what's not to like? Well, this drug has been around since the early 1990s. Marathon most certainly did not invent it. Nor did they think of applying it to DMD patients – the biggest clinical trial of the drug for that indication was done over twenty years ago, by someone else. DMD patients in the US were already taking the (unapproved) drug by importing it from Canada. Marathon just dug through the data again and ran a trial in 29 patients themselves, from what I can see. I should note that this is not any sort of cure, nor does it address the underlying pathology of the disease. The steroid treatment makes muscle strength in DMD patients stronger – barely. But even for that benefit, US patients will now have to get it from Marathon at something like 50 to 100 times the former price.

[...] So while I defend the FDA's function of making it tough on new drugs (making them prove safety and efficacy), I cannot stand how loose they are with old generic compounds. The agency hands out extremely valuable rewards like lollipops in these cases – a priority review voucher can be sold for hundreds of millions of dollars

[...] And they're also allowing the likes of Marathon to make the rest of the drug industry look like greedy sociopaths. Marathon, Catalyst, T*ring and all the rest of the people who are pulling these tricks have the word "Pharmaceuticals" in their name, but they are not drug companies. They discover nothing. They do no research. They take virtually no risks. They exist only to play legal games and watch the money roll in.

[...] As for the FDA, the agency probably can't change this on its own, though, even if it wants to – Congress has to act to give them the authority to deny market exclusivity or priority review vouchers under some conditions. Either that, or we should rethink these incentives entirely, because they are (clearly) too easy to exploit for fast bucks.

https://en.wikipedia.org/wiki/Deflazacort

Also at ArsTechnica.


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  • (Score: 2, Informative) by Anonymous Coward on Sunday February 12 2017, @04:06PM

    by Anonymous Coward on Sunday February 12 2017, @04:06PM (#466179)

    In this case the FDA should not be involved at all in regulating anything except fraud.
    ...
    If someone sells chalk pills as aspirin, then they can get involved.

    You are hopelessly naive. The FDA wasn't created out of nowhere. It exists because people were being killed. [wikipedia.org]
    No amount of after the fact action can undo death or serious injury.
    The FDA is imperfect because it is a creation of imperfect humans, but your 'solution' is a recipe for far worse results.
    We've already been down that path.

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  • (Score: 2) by migz on Sunday February 12 2017, @05:08PM

    by migz (1807) on Sunday February 12 2017, @05:08PM (#466208)

    > You are hopelessly naive.
    Ad hominum
    > The FDA wasn't created out of nowhere.
    I never claimed that it was.
    >It exists because people were being killed.
    Yep, that's fraud.
    > No amount of after the fact action can undo death or serious injury.
    Yep.
    >The FDA is imperfect because it is a creation of imperfect humans,
    Yep.
    >but your 'solution' is a recipe for far worse results.
    Nope. You have not refuted a single word, nor have you presented anything in support of your contention.
    > We've already been down that path.?
    Really? There was a time that the FDA only acted as a vetting agency, and had competition? When was this?

    • (Score: 0) by Anonymous Coward on Sunday February 12 2017, @05:48PM

      by Anonymous Coward on Sunday February 12 2017, @05:48PM (#466220)

      > Ad hominum

      Nope. For your future reference:

      Ad hominem: "You are wrong because you are stupid."
      Not ad hominem: "You are stupid because you are wrong."

    • (Score: 1) by Roger Murdock on Monday February 13 2017, @12:43AM

      by Roger Murdock (4897) on Monday February 13 2017, @12:43AM (#466383)

      >>It exists because people were being killed.
      >Yep, that's fraud.

      It's not fraud if the deaths were from compounds that were accurately listed.

      > nor have you presented anything in support of your contention

      Neither have you really, just a bunch of opinions and something about an FDA conspiracy. How is any research going to be funded if the final product will just be copied as soon as it hits the market? Or do you think R&D costs are actually so low (if it weren't for the FDA) that being (marginally) first to market would make up for it?

  • (Score: 2) by sjames on Sunday February 12 2017, @05:46PM

    by sjames (2882) on Sunday February 12 2017, @05:46PM (#466219) Journal

    There is justification for regulating novel drugs and inactive ingredients in drugs, but fundamentally, the FDA is just as much after the fact as anyone else. They do not have anything in place that could actually prevent a bad actor from including a toxic substance into a remedy except the knowledge that the after-the-fact consequences would be ruinous.

    It's fine that we have the FDA provide a means by which a novel substance can become approved for human consumption. But once it is, the FDA should butt out other than periodic checking that the drug contains what it says it does in the amount it claims (or perhaps the FTC should do that, they seem to manage it without quadrupling the price).