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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) by migz on Sunday February 12 2017, @05:12PM

    by migz (1807) on Sunday February 12 2017, @05:12PM (#466211)

    > Do you have a better idea?
    Sure. Don't grant monopolies.
    > Doing research, developing drugs, and running clinical trials all cost money.
    Sure. None of those should be required to manufacture and distribute substances.
    > That money has to come from somewhere
    No it does not. You only need the money if the FDA forces you to do it. Otherwise people can find other ways to fund research, trials, and drugs.
    > ... any people are not happy with tax money even paying for the first part.
    I'm not happy with tax money paying for ANY part of this WHATSOEVER. The FDA should be self funding.

    Starting Score:    1  point
    Karma-Bonus Modifier   +1  

    Total Score:   2  
  • (Score: 0) by Anonymous Coward on Sunday February 12 2017, @10:43PM

    by Anonymous Coward on Sunday February 12 2017, @10:43PM (#466334)

    Otherwise people can find other ways to fund research, trials, and drugs.

    Like what?

    Without patent protection, how would pharmaceutical companies fund the research necessary to develop new drugs? Should they try to rely on trade secrets, enter into exclusive contracts with healthcare providers, or should they just stop making new drugs?