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.
