Normal disclaimer: I am not a lawyer just a lay observer.
I was at the 3rd Annual World Congress Summit on the Evolving Role of Medical Affairs. As in the last two years, one of the highlights is the presentation by a representative of the OIG and US States Attorney on Off-Label Promotion.
Usually this is an opportunity for them to remind us that pharma is not allowed to promote off label, trot out examples of people who were prosecuted for off-label promotions (which are almost exclusively Sales and Marketing examples, not MA examples) and then encourage us to snitch on our organizations if we think we see this behavior.
But this year was different. This year we were all introduced to an important new term – Off-label Plus. What does Off-label Plus mean? It’s how they refer to cases that they are willing to prosecute. In light of the Caronia ruling (an overview of which you can find here, with subsequent commentary here and here), they are no longer willing to base cases on simply promoting off label (assuming the test laid out in Caronia that the off-label information presented is from a credible, unbiased source, like a “real” journal, and the presentation is not misleading). Instead, they are only willing to go after cases where there is Off-Label Plus something else, like Kickbacks or Fraud of some type.
In my opinion this is huge for medical affairs – most medical affairs organizations are unwilling to proactively share even an article published in the NEJM if it is off-label out of fear of being accused of promoting off-label. Instead we wait to be asked, since responding to a question is not promotion. I think the fear of promotion is now unjustified.
The simple reality is that even before Caronia no medical affairs employee has ever been prosecuted for simply providing accurate, non-misleading off-label information. Caronia was a sales guy, not medical affairs. The only example that the prosecutor could cite of an MA employee being prosecuted was a device company where the medical affairs lead used speaking fees as a kick backs. Now that Caronia is out there, I think the risk is even lower.
Just like our treatments, all of medical affairs is a risk / benefit. If we wanted zero risk, we would not have medical affairs or sales or marketing for that matter. Instead we reduce our risks through the use of strong processes and a compliance function to ensure those processes remain in place. It is my assertion that providing credible, non-misleading peer-reviewed published off-label data pro-actively is no longer a major risk, assuming there are procedures in place to avoid all the other “Plus” activities.
I don’t expect this to change overnight, but some organizations are going to start operating this way and when the sky does not fall, all medical affairs organizations will be operating this way – my guess is within 5 years. And this is all for the best – its good for HCPs because they will have the latest information, its good for patients because their HCPs will be well informed and its good for medical affairs because it allows us to do our jobs even better than today.
What do you think? Leave a comment by clicking here.