off-label uses exist and they know
these uses benefit patients, they do
not want those uses to be commercially exploited by manufacturers.
If off-label information is generally
known and physicians do it on their
own without any active inducement
by the manufacturers, then there
is no problem with off-label use.
Problems happen when manufacturers go out and actively talk about
that off-label use without getting
the agency’s blessing on it.
The only condition they have
would be on a physician-owned
distributorship, called a POD. And
in the case of a POD, the agency
certainly considers the physician
now no longer a physician but actually a manufacturer or a distributor, so their liabilities change.
In another document, called a dot-com guidance, the FDC actually is
talking about what should be the
font size, what should be the positioning of text when looked at on
mobile devices. So they’re talking
of smartphones. They read emails.
They watch web pages online. This
is a 50-page guidance that came
out of FDC, this talks about promotion of products and having
disclaimer information available.
SN: It sounds like the FDA’s main
concern is to take existing requirements, like an existing paradigm
through traditional marketing channels, and try to apply that to social
media, which is really quite different. But social media changes so
often, it’s really more about listening
to customers versus actually marketing. Are there some best practices
that you’re seeing or maybe that you
encourage some of your clients to
take on in terms of utilizing the various social channels?
MK: Yes. Actually the FDA is not
averse to manufacturers using social media to market their devices.
So what we do advise is, of course,
submitting everything to the Office
of Prescription Drug Promotion
or the Office of Device Promotion
within the CDRH for medical devices. If you are planning to have
a Facebook page, for example, for
your product, or if you’re planning
to have a website dedicated to your
product, then submitting all the
content that’s going to appear on
the website and actually submitting a potential website with all its
color schemes and all the different
links on it, to FDA’s advertisement
division for review before releasing
them is always a very good idea.
If you are going to allow consumer
forums, where people can post
comments, either on your website
or on your Facebook, then you
certainly want to make sure to
have some kind of control, some
kind of review of any information.
Companies should have standard
processes for managing their information outlets, no matter what
First, have the agency look at it
and let you know if there is anything objectionable, and listen
to them and revise it. Second,
have standard processes where
you define what are your dos and
don’ts for your information outlets.
Third, have individuals who are
experienced and trained to moni-
tor those things look for those red
flag issues. For example, if you see
an off-label promotion, an off-label
use of a device being discussed
on a forum that you run, then
it’s very important for someone
within your staff to post right away
a disclaimer information that this
is off-label and the company does
not endorse it.
The FDA does mention that in
their off-label promotion of label
guidance: whenever a manufacturer encounters or becomes aware of
off-label information, they are supposed to provide full disclosure to
the requester of the information,
which includes telling them that
this is not something that has been
approved by FDA, so there could
be risks that they are not aware of.
Direct them to R&D staff and not
to marketing staff in terms of the
tone of the information that goes
out, and also provide other information that the manufacturer may
be aware of, even information that
may not be favorable to your product, provide all the information,
and then document it in detail.
And even for on-label use, it’s very
important to have certain rules
when you talk about social media.
First, have the [regulatory]
agency look at [your con-tent] and let you know if
there is anything objectionable, and listen to them and
revise it. Second, have standard processes where you
define what are your dos and
don’ts for your information
outlets. Third, have individuals who are experienced
and trained to monitor those
things look for those red flag
SN: So if a patient submits a question regarding a device via Twitter, how is it possible to present
balanced information on indications, risks, benefits, etc. given the
MK: Very good question, and
actually there is a direction from