Free speech is dangerous and illegal in the wrong hands

[Black Jack]

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 for their main role which is to simply parrot the pharmaceutical companies 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.

 

[Anonymous]

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 for their main role which is to simply parrot the pharmaceutical companies 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.

Your analogy about a rep opening a practice and seeing patients is off base. The promotion is being targeted towards HCP's mostly physicians who have had years of training and clinical practice. That training should allow them to evaluate the information that is being given to them whether it is on or off label. If a physician with all their training can't evaluate what an "unqualified salesman" says then that would be an issue whether the rep is promoting on label or not. If a trained physicians can't evaluate the information a rep provides then your issue is the physician training, not the pharma company.

Based on FDA guidelines, reps can't even bring in a study published in peer review journals found in even the most credible sources like NEJM and discuss the trial if this information is not in the label. If you take debilitating diseases (after companies complete trials it still takes at least a year to get a label change) that means thousands of patients suffer. The reality is physicians can't keep track of all the studies that are published. So how does a physicians ask an unsolicited question about a trial they know nothing about? Because under FDA guidelines these requests need to be unsolicited. So by the letter of the regulation, neither a rep or MSL can proactively bring that information up. As long as what a rep says is valid and is supported by published data in peer review journals, why shouldn't they be allowed to discuss it?

 

[Anonymous]

The real thing to fear is if the court rules in Amarin's favor and a physician prescribes for an off-label use that leads to a less than expected response or an unexpected side-effect and the money-grubbing ambulance chasing tort lawyers get involved. I can see the flood of class-action lawsuits naming the doctor, pharmacy, sales rep, DSM, RSM, and anyone else the slimy bottom feeder can think of naming.