Point of view of the recently released draft guidance for industry for pharma and social media by Navicor - an Oncology focused marketing and communications company.

1. January 2014
CORTHOUGHTS
“...a firm
generally is not
responsible for
UGC (User
Generated
Content) that is
truly
independent of
the firm”
It is time for comments!
The FDA issues draft guidance on social media
By Philip Storer
On Monday, January 13, the FDA issued
the long-awaited draft guidance for
branded pharma products in social media.
While much of the guidance speaks to
“user-generated content” (UGC) and “realtime communications,” the FDA makes
clear that these terms refer to “blogs,
microblogs [Twitter], social networking sites
[Facebook], online communities, and live
podcasts.” Much of what the FDA said is a
common-sense reiteration of what many of
us have assumed about the responsibility
of pharmaceutical companies. However,
this guidance will help usher pharma into
the next phase of online engagement.
The first thing to note about the draft
guidance is that it is nonbinding and
labeled specifically not for implementation.
This draft is for the purpose of gathering
comments. Pharmaceutical brand teams
need to seek the counsel of their legal
teams for final guidance on how their
brands should proceed in engaging in
social media. Navicor, in conjunction with
the digital teams at inVentiv Health, is
gathering input from digital strategists
around the country to submit comments to
the FDA. The information contained in this
document should be considered Navicor’s
interpretation of the draft guidance for the
purposes of gathering and submitting
comments.
The guidance can be broken into two main
questions. First, what responsibilities do
pharma companies have over the content
generated on their pages? Second, how do
pharma companies follow postmarketing
reporting requirements when responding to
UGC given that UGC is displayed in real
time? To answer the first question, the FDA
recognizes the difference between
properties created by industry and thirdparty online properties such as Facebook,
Twitter, YouTube, etc. In either case, the
FDA states that pharma companies are
responsible for content if they are
“influencing or controlling” the promotional
content whether “in whole or part.” This is a
surprise to no one. What’s most interesting
is the final portion of their answer to the
question of responsibility. The FDA states,
“a firm is responsible for the content
INTERESTED IN LEARNING MORE? PLEASE CONTACT PHILIP STORER @ PHIL.STORER@NAVICORGROUP.COM

2. CORTHOUGHTS January 2014
It is time for comments!
The FDA issues draft guidance on social media
By Philip Storer
generated by an employee or agent who is
acting on behalf of the firm to promote the
firm’s product.” While this may at first seem
to surprise no one, the statement is further
clarified: “A firm generally is not
responsible for UGC that is truly
independent of the firm.” This is the longawaited guidance that pharma needed in
order to engage in a channel such as
Facebook. Bryan Kaye, a digital strategist
from Chandler Chicco, states, “This may
be a game-changing statement for
something that has been looming over the
industry since the dawn of social media. It
seems to mean that it is not the
responsibility of the brand if a patient were
to comment on a pharmaceutical branded
product Facebook page or YouTube
channel.”
time communications.” The guidance goes
on to clarify that pharma companies must
submit to the FDA a monthly link to the site
with a date range and a cross-reference of
the most recent submission date and that
this submission does not require
screenshots. If, however, the UGC is
behind a log-in and password, the pharma
company must also submit all content
related to the discussion and include
screenshots of the site on a monthly basis.
With this in mind, it is clear that pharma will
be well served to ensure that all real-time
communications remain publicly available,
not behind a log-in.
The guidance for submitting third-party
sites requires that pharma companies
“submit the home page of the third-party
site, along with the interactive page within
The answer to the second question on
the third-party site and the firm’s first
how pharma is to follow postmarketing
communication.” The guidance for monthly
reporting requirements for UGC follows the submission then follows the same rules as
same structure as the answer to the first
sites owned by the pharma company. If the
question. The FDA acknowledges that
site is publicly available, pharma must
there is a difference between online
submit a name, URL, and date range on a
properties owned by the pharmaceutical
monthly basis. If the site is behind a log-in,
company—such as your product.com—
the content must be submitted in the same
and online properties that can be
way as described above for pharma.comconsidered third-party, such as Facebook, owned properties.
YouTube, Twitter, Blogger, SlideShare, etc.
In addition to distinguishing between these While we must wait for the final guidance
two types of online properties, the FDA
to be issued by the FDA, it is encouraging
further notes that it understands that some that the FDA is looking to provide clarity on
of these properties require a log-in to view what pharma companies and their
content, while others are publicly available. agencies are responsible for and how we
After having made these distinctions, the
are to submit. Undoubtedly, this will help
draft guidance indicates that sites owned
move pharma into the next phase of online
by industry that include UGC are required
customer engagement.
to “include annotations to describe the
parts that are interactive and allow for real-
ABOUT THE AUTHOR
Phil began his career in digital as a front end HTML/
CSS developer. Since making the switch to strategy,
Phil has drawn on his technical background to lead
digital projects for a diverse set of clients. He brings
over 10 years of digital marketing experience to The
Navicor Group.
INTERESTED IN LEARNING MORE? PLEASE CONTACT PHILIP STORER @ PHIL.STORER@NAVICORGROUP.COM