Off label litigation is a great example of my point. Extremely muddy waters.
Physicians constantly ask pharma about and explore off label drug prescriptions. This is legal: psychiatrist can tell you to take a drug approved for nerve pain for depression. There is research showing it works for depression but it has not technically been added to the label of the drug yet following fda approval. Pharma can provide the studies and answer limited questions on the topic (but no clear guidance) but cannot "promote" this. Is presenting the research promotion? Is the rep discussing it with the doctor promotion? Etc
Just to add how difficult these off-label uses are beeing managed.
Every content we provide (be it in a discussion, or a comment in one if our forums or as part of a symposia) needs to be checked for offlabel use. This is a nightmare and every single screen of my apps or of the content that is uploaded needs to be reviewed by medical teams/compliance. Its a nightmare.
Now tell me what is “was promoted by pfizer”? A doctor saying it in a comment/presentation that he tried this with on patient and storing this on one of our digital platforms?
It’s really grey water…
And add to this hard times for medical reps after covid.
> Physicians constantly ask pharma about and explore off label drug prescriptions.
Yes, and in other companies employees go through training when dealing these things to avoid any type of off label advertisement. It’s not “muddy” it’s like claiming lawyers think DUI is muddies waters because there is just so many things to consider. No one in their right mind in the industry would ever think that. And while the terminology is perhaps foreign to people not in the industry, everyone understands that you can’t just go out claiming that paracetamol cures cancer, no mater how good a business case you’ve made for additional sales.
> Pharma can provide the studies and answer limited questions on the topic
Sure and then get fined for off label marketing. The lines aren’t difficult to understand and they are way harsher than you seem to think. Something as behneighen as a rep liking a Facebook post covering a university article saying “paracetamol shows promise as cancer cure” is overstepping the line because the like can be interpreted as off label marketing.
Physicians constantly ask pharma about and explore off label drug prescriptions. This is legal: psychiatrist can tell you to take a drug approved for nerve pain for depression. There is research showing it works for depression but it has not technically been added to the label of the drug yet following fda approval. Pharma can provide the studies and answer limited questions on the topic (but no clear guidance) but cannot "promote" this. Is presenting the research promotion? Is the rep discussing it with the doctor promotion? Etc
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