What does the recent draft guidance from the FDA for social media mean for Pharma brands? Find out what Star Life Sciences thinks, then visit us at starlifebrands.com to see more articles with our thinking.

1. Comments Enabled
FDA Guidance on Social Media &
User-Generated Content

2. An Analysis of FDA Draft Guidance For Industry: Fulfilling Regulatory
Requirements for Postmarketing Submissions of Interactive Promotional
Media for Prescription Human and Animal Drugs and Biologics
January 2014
Access the FDA Draft Guidance Here

3. FDA released long-awaited draft guidance
governing the use of social media by
pharmaceutical and biotech marketers on
January 13, 2014.
While far from exhaustive, the document
contains, among other things, specific new
guidance on the use,
documentation, and
submission of social media
and similar channels
that entail the use of user-generated content.
3

4. Key issues are outlined here.

5. Do I Own It?
If a company marketing a pharmaceutical or biotech brand exerts
significant influence over a site or online service, that firm has a
responsibility to submit the entire current contents of the site or service.
The definition of influence is the key.
Merely buying advertising space on the site does not trigger ‘ownership’
responsibilities; the firm is still responsible for proper submission
of the advertising materials given to the site, of course. Dictating
or negotiating preferable placement of such advertising constitutes
influence of the sort that triggers ownership responsibilities.
We interpret this guidance such that, for instance, simple selection
of an expensive, prominent placement is permissible without
submission of the entirety of the surrounding content; purchase
of such a placement contingent on its appearance next to an
editorial column by a prominent KOL would trigger the requirement.
While this does not constitute a bright-line rule, we believe that this
guidance will suffice in most conceivable contemporary instances.
5

6. Promotion
rd
on 3 Party Sites
The guidance reaffirms the obvious –
Brand X
@iambrandx
Brand X has Lorem ipsum dolor sit amet, consectetur adipiscing
elit. Pellentesque eget velit eu magna dignissim commodo ut a est.
brandx.com
Free health screenings may be in your area this month including
BMI, blood pressure & more! Learn more http://ow.ly/sSzaM
The winter games are starting soon! What’s your favorite
winter sport?
Did you know our iPad app brings a virtual Brand X store right
to your living room. Try it today! http://ow.ly/sjEfm
the marketer is
responsible for
regulatory submission
of promotional
communications
via services like Twitter, Facebook, etc.
The guidance also makes clear that the
firm is responsible for submitting such
communications as tweets from sales reps
or other employees, blogs or microblogs
maintained by employees or contractors,
etc. Thus, the company’s social media policy
should prohibit dissemination of promotional
content–even an innocuous tweet about
MOA–from employees unless specifically
requested.
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Share your best savings tips and we’ll RT our favorites! We’ll go
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6

7. The guidance makes it clear that
user-generated content
(UGC) from non-affiliated
users is NOT the
responsibility of the firm,
and need not be submitted. This applies to
third-party sites and, potentially, brand sites, if
they have a forum or similar venue for display or
dissemination of user-generated content. While
not addressed in this guidance, it should not be
construed that such guidance frees the firm from
established responsibility in regard to reporting of
adverse events, if identifiable adverse events are
asserted or suggested via UGC.
Promotional
communication IS
your responsibility
Good times with good people!! @7oasis @jazminsisters @thebrucewaynne #BRANDX #HBK… http://instagram.com/p/jaflwBy12H/
UGC - Not your responsibility
Free health screenings may be in your area this month including
BMI, blood pressure & more! Learn more http://ow.ly/sSzaM #projecthealth #BrandX
Mittens or gloves – what’s your go-to way to keep your hands warm
when temperatures drop? #BrandX
7

8. nuts & bolts
Suggested Submission
Procedure & Timing
The final section of the guidance document, Recommendations
for Submitting Interactive Promotional Media, is a real eye-opener.
One can easily imagine the onerous regulatory submission burden
an active brand Twitter or Facebook account could generate.
FDA lays out a series of simple
recommendations for
pharmaceutical marketers.
8

9. nuts & bolts
Company-Controlled Sites
“At time of first display, the firm should …submit in its entirety all sites for which it
is responsible on Form FDA 2253 or Form FDA 2301.” For example, if a brand site is
adding a comments feature, resubmit the entire site, and include the new feature,
with annotations to indicate its function(s).
the firm need only supply an
updated listing of the site via form 2253
or 2301, every 30 days. The details of the listing are
Thereafter,
provided on the following page.
9

10. For a third-party site (e.g., Twitter), the firm should initally
submit, as above, the ‘home page’ of the site and the
interactive page(s) within said site. Implementation of
this portion of the guidance will depend largely on the
third-party site in question. Here, once again, the burden for
ongoing regulatory submissions
comprises submission of an
updated listing, every 30 days,
via form 2253 or 2301.
nuts & bolts
Third-Party Sites
10

11. What’s in a Listing?
2253
Less than we had suspected, frankly. Submitted under 2253 or 2301,
the listing comprises …”the non-restricted sites for which the firm is
responsible or in which it remains an active participant and that
include interactive or real-time communications.”
There is no requirement for a visual
representation of the interactive
communications.
The listing includes only the site name, URL, and date range, along with
a cross-reference to the most recent submission of the site. Better yet,
multiple sites may be submitted under a single form. Our interpretation
is that all appropriate properties or sites for a given brand can be submitted
under a single 2253. Furthermore, we do not believe this necessitates
monthly updates to inventory/control numbers.
11

12. Another notable point
A notable exception
here is that FDA expects to see genuine, unaffiliated
UGC interspersed with promotional messages. It is
not necessary to ‘clean up’ the site at submission as
reviewers expect to see, for example, user-generated
tweets interspersed with branded tweets on a brand’s
Twitter page. Of course, any inappropriate UGC
should be removed per site moderation policy, but
that is not a matter FDA intends to exert particular
influence over.
is the case of restricted sites, like sites that require
a password (to post comments, anyway). In this
case, FDA wants to see the whole site, but again,
recognizing the realities of ‘real-time’ content,
FDA requests only that
such submissions be
made every 30 days.
12

13. Star Group’s View
The language and content of these recommendations make it apparent to us that
FDA is actively seeking to empower use of social media
and other ‘real-time’ interactive promotional media. While the guidance is not
binding, FDA has stated that it will exert enforcement discretion around the key
items described in this document.
We feel that the risk exposure associated with pharmaceutical and biotech
brands’ use of social media networks, blogs, forums, etc. is substantially
less than in the past. The guidance presented is actionable and, on its
face, reasonable. As ever, FDA has avoided being overly specific in some
definitions, as a hedge against future actions that violate the intent
of this guidance.

14. And intent is the key here.

15. Star Group feels strongly that a good faith
effort to engage in social media and other
interactive promotional media can pay substantial
dividends when deployed as part of an integrated
communications strategy to reach members of
key target audiences.
This good faith effort includes:
• Content strategy for key audiences
• lear value proposition for people
C
to engage with brand and its reps
• Well-defined success metrics
• Moderation policies and staff
• Transparency
• Flexible approach from all stakeholders
Star believes the quality of flexibility to be vitally important to success.
The tools of the trade will evolve over time, and it is important
that marketers evolve as well, while preserving core principles like
transparency, respect for the audience,
and timeliness of response.
This kind of ongoing and transparent conversation with patients, physicians,
caregivers, etc. is new for pharmaceutical marketers. A willingness to learn from
mistakes – and to make these mistakes in the first place – is paramount to success
in this realm.
15

16. #TheEnd
Want 2 learn more?
Tim R. Garde
Managing Partner
Star Group / Star Life Sciences
Synegrated Communications
215.875.4313 (l)
215.815.0075 (m)
tgarde@stargroup1.com
stargroup1.com
starlifebrands.com
©2014 Star Group Communications, Inc.