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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.

Also at ArsTechnica.

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  • (Score: 2) by Justin Case on Sunday February 12 2017, @12:47PM

    by Justin Case (4239) on Sunday February 12 2017, @12:47PM (#466119) Journal

    Yes, I understand the difference, and since you do too, buy the rights to the old tired one and sell at 2x.

    the very regulators you seem to value so much

    Uh, no, that would be someone else. I'm strongly deregulate when it comes to the FDA. You should have a choice whether or not to buy and use FDA approved substances.

    they're greedy bastards.

    In other words, they're a group of people who want or need money. Since you don't want or need money (great to be you I guess) get off your high horse and do something good for the world instead of mumbling around your Cheetos about what others should do. Start an unprofitable pharma company. Round up investors who, like you, don't want or need money but just want to Do Good Things For The World. Promise your investors a negative rate of return as you spend all their money developing or buying your product line. Sell at a loss and go to sleep every night knowing you're not a bastard.

    What are you waiting for?

    Starting Score:    1  point
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    Total Score:   2  
  • (Score: 2) by sjames on Sunday February 12 2017, @05:17PM

    by sjames (2882) on Sunday February 12 2017, @05:17PM (#466212) Journal

    You claim to know the difference, but you demonstrate that you don't.

    If the FDA were stripped of the power to grant exclusivity in exchange for ass kissing and we then enforced existing laws against such practices as paying potential competitors to stay out of the market AND we force the FDA to treat generics as generic rather than treating them as a brand new product, we might actually see companies willing to produce generic drugs in exchange for a reasonable profit (that is, not at a loss but not for hundreds of times the cost).