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  • maxdaddyo maxdaddyo Oct 30, 2013 5:30 PM Flag

    The "grey area" of off-label marketing.

    During the course of conversations with physicians and medical groups one of the things Pharmaceutical and Biotech companies are usually actively looking for are "volunteers" to conduct various field trials (NOT FDA trials)...And in the conversation with Patty she indicated that Q has over 50 known trials going on right now, some sponsored by Q, many not.

    So here is how reps who are commissioned to seek out such opportunities can cross this grey area. They are in a discussion with a physician/medical group who asks a relatively simple question like "Has Acthar ever been used in the treatment of XYZ disease"? And the rep answers, "No, but we think that would be a great candidate for Acthar and an independent evaluation, and would love to work with you on that". Could even go so far as offering to make Acthar available gratis. Technically, this would be a violation of "off label" promotion and could be called into question. On the other hand, the only other way would be far more dangerous with physicians having no input whatsoever from the drug company itself. A bit of a Catch-22 in my opinion.

    All this said, there is a case (sorry I don't have the name off the top of my head) in which a pharma went through all the legal machinations of federal courts and "off label" promotion was deemed "Free Speech". If I recall correctly it was taken to the Supreme Court which remanded it back to the lower court which had already ruled it as "free speech"....I don't want to presume my memory has this 100% so anyone that knows this case should feel free to weigh in with specifics. IF I have this right then it is possible that the DOJ and SEC are on a fishing expedition to try to relitigate this with different specifics hoping for what would effectively be a reversal of that ruling.

    Finally, while there certainly has been investigations and litigation against many pharmas/biotechs (see Pharmamans research post on this), there is a specific burden of "harm"...

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    • Ok I get the whole thing.
      But, in the eyes of an investigator did qcor gain or potentially gain anything out of their business practice, or jeopardize the health of patients, or cross the grey area?
      Perhaps Max a little more explanation of the 50 studies.
      In my little known world of pharmacy, I don't understand why you would pursue more studies when you haven't developed the current.
      Furthermore would new indications require the same FDA approval as "new" drug or are there methods to bypass that route?
      Just asking. Perhaps some clarity here could help solve where this investigation may lead.

      • 1 Reply to stampings_al
      • No evidence of any harm IF it is the story I am guessing it is (see my various posts on this). When Pharmaman and I spoke with Patty we specifically requested that those 50 Plus independent studies be profiled during the conference call along with any relevant notes that they could share. Didn't happen.

        As for non-FDA approved indications, you just need to look at what they have said about those three (including ALS) under current FDA Trials. Because of the safety history they can begin with Phase II on any of these and limit much of the safety (not all) components of the rest of the trial. But there still needs to be safety (adverse affect analysis) information collected and presented to the FDA to get these new indication approved. For diseases like ALS and Acute Respitory disease, it is highly likely that if these current test prove reasonably successful the rest of the trial will be fast tracked as there are no other available remedies (as stated during the conference call).

    • thanks for the update maxdad

    • As best I recall, while there certainly have been investigations and litigation against many pharmas/biotechs (see Pharmamans research post on this), there is a specific government burden of "harm" that must be met to actually take civil/criminal action beyond a cease and desist order with otherwise relatively minor fines for rule violations. SO IF, this "case" is truly one of aggressive marketing of "off label" indications, the chances of it resulting in "harm" (which could lead to more serious consequences) are minimal at worst.