Whistleblower for off label promo

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I see the trolls are at it again with the fake rep posts. Take your 'whistle blowing' to the FDA ... not cafepharma. Not easy to do when you're not actually a rep or provider, is it?
 






Every article I have read on this subject including the very well argued, “FDA Prohibitions on Off-Label Marketing Do Not Violate Drug Manufacturers’ First Amendment Rights,” by STEPHANIE M. GREENE, has failed to mention something that seems glaringly obvious to me. Pharmaceutical Sales Representatives simply do not have the credentials to have clinical discussion of this type with physicians. They are not MD’s, Pharm Ds, RNs, NPs, PA’s and most only have a Marketing or Sales Background with no clinical knowledge base outside of the biased, one-sided sales training provided to them by the company they work for. This is barely adequate to, as Sam Pharmacist quite correctly stated “parrot the pharmaceutical company sales pitch,” to physicians let alone delve into off-label applications for their product that could have potentially devastating results on the patients who take them. That is why the FDA already allows Pharmaceutical Companies to convey this type of Off-Label material directly to physicians in response to an unsolicited request and in some cases the direct mailing of clinical trials to their office.
If the Courts rules in favor of Amarin then we might as well allow Pharmaceutical Representatives to open up their own offices and start seeing patients directly. Free Speech when it pertains to physician to physician discussion is one thing but allowing unqualified salesmen who are clearly motivated by their own self-interests to carry out these discussions is reckless and quite possibly criminal.
 






Black Jack said:
Every article I have read on this subject including the very well argued, “FDA Prohibitions on Off-Label Marketing Do Not Violate Drug Manufacturers’ First Amendment Rights,” by STEPHANIE M. GREENE, has failed to mention something that seems glaringly obvious to me. Pharmaceutical Sales Representatives simply do not have the credentials to have clinical discussion of this type with physicians. They are not MD’s, Pharm Ds, RNs, NPs, PA’s and most only have a Marketing or Sales Background with no clinical knowledge base outside of the biased, one-sided sales training provided to them by the company they work for. This is barely adequate to, as Sam Pharmacist quite correctly stated “parrot the pharmaceutical company sales pitch,” to physicians let alone delve into off-label applications for their product that could have potentially devastating results on the patients who take them. That is why the FDA already allows Pharmaceutical Companies to convey this type of Off-Label material directly to physicians in response to an unsolicited request and in some cases the direct mailing of clinical trials to their office.
If the Courts rules in favor of Amarin then we might as well allow Pharmaceutical Representatives to open up their own offices and start seeing patients directly. Free Speech when it pertains to physician to physician discussion is one thing but allowing unqualified salesmen who are clearly motivated by their own self-interests to carry out these discussions is reckless and quite possibly criminal.
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Quite likely one of the most intelligent posts I have seen on this site. This succinctly describes the issue with off label promotions. Very well stated.
 






But off target cause if the info is already published and available in "the public domain", anyone should be allowed to discuss it. By this argument you say no reps should be allowed to speak on whatever info is out there but what about some putz that reads the same info is ok to talk about it. That's imminently more dangerous than a rep talking about it.
 






Anonymous said:
But off target cause if the info is already published and available in "the public domain", anyone should be allowed to discuss it. By this argument you say no reps should be allowed to speak on whatever info is out there but what about some putz that reads the same info is ok to talk about it. That's imminently more dangerous than a rep talking about it.
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What if the person that put the info in "the public domain" was an employee (or commissioned) by the company to publish it? That's the problem with the "public domain" - anyone can put anything out there they want without any verifications.
 






Anonymous said:
But off target cause if the info is already published and available in "the public domain", anyone should be allowed to discuss it. By this argument you say no reps should be allowed to speak on whatever info is out there but what about some putz that reads the same info is ok to talk about it. That's imminently more dangerous than a rep talking about it.
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You are comparing apples and oranges. The general populace discussing this information in “the public domain” is very different than a paid representative acting on behalf of the company who manufactures the product using off-label information to try and directly influence the prescribing habits of physicians. A “putz” discussing this information is relatively harmless as his conversation will not lead to a prescription being written for an unintended use. A Pharmaceutical Representative however is the perceived expert on the product and some physicians may not even realize that the data they are being provided is outside of the label which can and does lead to prescriptions being written. In most cases the patient will never know that it was actually a guy who graduated with a “C” average in Art History that influenced their physician to write the script he just gave them.
 












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