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Insmed Incorporated Message Board

  • rehdvm2004 rehdvm2004 Oct 3, 2013 8:52 AM Flag

    Off label use occurs often in veterinary medicine because . . .

    most drugs only get approved for human label copy, but most are preclinically tested in animals to establish safety. The net result is the criteria for off label use are easily met:

    1. The drug needs to be a pharmaceutical grade approved product;
    2. There needs to be a reference for the use in the species (Paul Flecknell and various Veterinary Pharmacology books provide the references);
    3. There needs to be a written protocol for the drugs use (dose, duration, route of administration, etc.); and
    4. The owner must sign an informed consent form.

    With these in hand, a veterinarian can prescribe any drug for any animal species.

    The guidelines were published by the AVMA 50 years ago and have been revised several times.

    I would suggest the AMA has similar guidelines because those were published after the Nuremberg Trials in 1945. Informed consent dates from the trial of Judge Ernst Janning following WWII. This judge said it was acceptable to perform "medical" procedures that were not approved for medicine without informed consent. This trial and this fact have been the basis for performing medical procedures on humans ever since.

    If you also remember, TOBI had a major fine because Novartis sales people were touting its use off label. That is not a doctor's prescription.

    Sentiment: Buy

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    • most drugs only get approved for human label copy, but most are preclinically tested in animals to establish safety. The net result is the criteria for off label use are easily met:

      1. The drug needs to be a pharmaceutical grade approved product;
      2. There needs to be a reference for the use in the species (Paul Flecknell and various Veterinary Pharmacology books provide the references);
      3. There needs to be a written protocol for the drugs use (dose, duration, route of administration, etc.); and
      4. The owner must sign an informed consent form.

      With these in hand, a veterinarian can prescribe any drug for any animal species.

      The guidelines were published by the AVMA 50 years ago and have been revised several times.

      I would suggest the AMA has similar guidelines because those were published after the Nuremberg Trials in 1945. Informed consent dates from the trial of Judge Ernst Janning following WWII. This judge said it was acceptable to perform "medical" procedures that were not approved for medicine without informed consent. This trial and this fact have been the basis for performing medical procedures on humans ever since.

      If you also remember, TOBI had a major fine because Novartis sales people were touting its use off label. That is not a doctor's prescription.

    • a CF NTM patient is not a dog. I was posting about reality. For the reasons I gave,off label is not a factor in possible Insmed revenues for investors.

 
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