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Thread: Drug companies are sitting on generics—43% of recently approved aren’t for sale

  1. #1
    Elder Arcanist
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    Drug companies are sitting on generics—43% of recently approved aren’t for sale

    Drug companies are sitting on generics—43% of recently approved aren’t for sale

    Of the more than 1,600 generic drugs approved by the Food and Drug Administration since January of 2017, more than 700—or 43 percent—are not for sale in the US, according to a new analysis by Kaiser Health News.

    The finding means that many pricy, brand-name drugs are not facing the competition that could help drive down soaring prices. Among the drugs missing in action are generic versions of the expensive blood thinner Brilinta and the HIV medication Truvada. Moreover, of the approved drugs that would offer a brand-name drug its first competition, 36 percent are being held off the market, the analysis found.

    Experts told KHN that the reasons drug makers may withhold an approved generic from the market are varied. Industry consolidation has made buying, manufacturing, and distributing generics more difficult in recent years. Generic drug makers also, as always, face patent litigation from brand-name makers. Then there’s potentially anti-competitive deals, in which brand-name drug makers simply pay generic makers to keep their product off the market for a while—a so-called “pay for delay” tactic.

    Lastly, there are internal decisions within a generic company that can lead to shelving a drug. For instance, a drug maker may shift its business strategy while it’s waiting for the drug to get approved, or the maker may delay a drug’s entry to the market until a strategic time.

    Whatever the reason, keeping approved generics from the market is “a real problem because we’re not getting all the expected competition,” FDA Commissioner Scott Gottlieb said in an interview with KHN.

    Generic approvals at the FDA have ramped up in recent years, and the agency is cracking down on anti-competitive tactics, Gottlieb said. Still, it’s a difficult problem to solve with so many factors at play, he said.

    He added that an FDA analysis found that on average it takes the introduction of five generic versions of a drug to the market to drive down a drug’s price to 33 percent of the original branded price.

  2. #2
    Banjo Duellist, 8th Dan
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    Re: Drug companies are sitting on generics—43% of recently approved aren’t for sale

    oh, surprise! shock!
    When the Old Guard dies,
    The cowards in the shadow rise,
    Their vile plots of cowardice and greed,
    Poison the land and nightmares arise,
    To terrorize and murder the common man.


    (and as usual, please forgive typos and crankiness if possible)

  3. #3

    Re: Drug companies are sitting on generics—43% of recently approved aren’t for sale

    pay for delay should be illegal and generic makers should be immune to patent litigation if they are using a formula with an expired patent. We need to get rid of that repatenting bullshit where a company an change one of the neutral chemicals such as a binding agent that holds the pill together and get a new patent.
    "When you name your baby Jeeves...you've pretty much set up his career for life. You don't see many Hit Men, for example, named Jeeves. "Pardon me sir, but I must wack you now."
    — Jerry Seinfeld

  4. #4
    Oni
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    Re: Drug companies are sitting on generics—43% of recently approved aren’t for sale

    They also tend to patent processes for production - complicating things as cheaply as possible to retain control of the process that produces things and increase the competitive gateway to entry into production.
    "Don't yell at S-D for using words you're not completely sure of, it embarrasses you. He's right anyway." - Alikat

  5. #5

    Re: Drug companies are sitting on generics—43% of recently approved aren’t for sale

    Why is a production method even patented or patentable? That is like saying you own the rights to using a telephone in a call center.

  6. #6
    Ellsworth M. Toohey
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    Re: Drug companies are sitting on generics—43% of recently approved aren’t for sale

    Quote Originally Posted by FilanFyretracker View Post
    Why is a production method even patented or patentable? That is like saying you own the rights to using a telephone in a call center.
    Using a telephone is a generic action. A manufacturing process can be very specific. Think of it as the difference between merely using a phone versus using a detailed script to deal with callers. I'm not saying that's the case, since I haven't seen the patent -- but it's very possible.
    Last edited by PPatty; February 11th, 2019 at 06:36 AM.

  7. #7
    Mangina at large.
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    Re: Drug companies are sitting on generics—43% of recently approved aren’t for sale

    Process patents have roots in chemical engineering, where someone would come up with a novel way of making something relatively common. In most cases, you couldn't patent the something, so the law allowed for the process to be patented. Think of something like steel. You can't patent steel, but you could patent a new, more efficient method of producing steel.

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