On Target about Off Label: Social Media Guidelines
We know we have to use social media. But there are two big
questions. How to use it? And how not to use it?
This article is edited
from an interview by
Scott Nelson, founder
of Medsider, with Dr.
Mukesh Kumar, Sr.
Director of Regulatory
Affairs and Quality
Assurance for Amarex
Sales and marketing executives
in the life sciences industry have
massive amounts of data—some
proprietary, some licensed from
3rd parties, and unfortunately,
much of it siloed in a manner that’s
not necessarily streamlined and
accessible. But you know that.
What you may not know is exactly
how the smartest companies are
starting to draw meaningful intel-
ligence from these massive silos of
data, resulting in a higher yield on
their sales and marketing invest-
ments and distancing themselves
from less sophisticated competitors.
How are they establishing a competitive advantage? What can we
learn from their performance? The
following 4 Key Themes tell the
Identifying Obvious and
Sources of Data
Scott Nelson: Thank you for
joining us today, Dr. Kumar. For
the benefit of our listeners, Dr.
Kumar’s key expertise is in global,
regulatory and business processes
for medical and diagnostic prod-
ucts. He’s a well-known expert in
global drug approval processes
as well and has been involved in
clinical trials in more than 60
countries. He holds a PhD in bio-
chemistry with a specialization in
virology, gene therapy and mo-
lecular biology. Dr. Kumar, I think
you’ve got an interesting story in
regard to a device that was recently
on the TV show Grey’s Anatomy
as it pertains to social media.
Mukesh Kumar: Certainly.
When we think of social media
we typically think of Twitter and
Facebook. But social media is bigger than that. It’s anything that is
in the public domain, on a website
or on a TV or radio program that
could be considered as an advertisement or marketing of a given
There was a warning letter issued
by FDA to a manufacturer of a
medical device in California conducting clinical trials on a cardiac
medical device. And their principal investigator (PI) knew one of
the writers on the TV show Grey’s
Anatomy, and he plugged the
device on one of the episodes, in
which the actors used that device
to treat a patient. And the PI acted
as a consultant and also had a brief
appearance on that episode.
The FDA found out about it and