This is a presentation I made at a Bayer HealthCare Grants4Apps™ meeting on June 11, 2013, in Berlin. It highlights some pharma social media and mobile app “milestones” or “firsts” that have paved the way for others to follow. I identify the “Pioneers” who have helped the industry navigate through “uncharted” territory lacking regulatory guidance. I also analyze some “mistakes” made by both leaders and followers. Only those who learn from thee mistakes of their competitors will move forward. Those who learn from their OWN mistakes will move forward fastest! Finally, I present some ideas for “best practices” and “guiding principles” that may help you avoid regulatory actions.

1. © 2013 Pharmaguy
Overcoming Pharma’s Social
Media & Mobile Challenges
Bayer Pharma Meets
Pharmaguy Meets Startups
11 June 2013 * Berlin, Germany

2. © 2013 Pharmaguy
Learn from Milestones & Mistakes
 Milestones – Important “firsts” have
paved the way for cautious followers.
 Mistakes – Best way to learn & benefit
from your competition’s errors.
“Constant Effort and Frequent Mistakes
are the Stepping Stones to Genius”
Elbert Hubbard, American writer
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3. © 2013 Pharmaguy
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Pharmaguy Has Been There (at FDA), Done This
 Testified as Panel Member at 1996 FDA
Hearing on Internet
 Co-Founded Internet Healthcare
Coalition (1997)
 Co-Authored the eHealth Code of
Ethics (2000)
 Blogged About Pharmaceutical Digital
Marketing Practices Since 2005
 Presented Survey Results at the 2009
FDA Hearing on Social Media

4. © 2013 Pharmaguy
FDA Sends 14 Warning Letters
FDA sends 14 letters on a single day
to major pharmaceutical companies
concerning their Google and Yahoo
Rx paid search ads. Letters were
dated 29 March 2009, but made
public on 2 April 2009.
April 2, 2009
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1
April
2009:
Pharmaguy
posted
fake
“April
Fools”
press
release
announcing
publica;on
of
FDA
guidance
on
pharma’s
use
of
social
media.

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FDA Hosts Public Hearing
November 12-13, 2009
“This meeting and the written comments
are intended to help guide FDA in making
policy decisions on the promotion of
human and animal prescription drugs and
biologics and medical devices using the
Internet and social media tools.”
April 2, 2009: Pharmaguy issued first
public call for FDA public hearing on
social media. “We should make sure that
when it comes time for the FDA to
actually create a guidance document on
social media that it does it with input from
ALL stakeholders.”

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 "Miscellaneous Provision" of the "Food and
Drug Administration Safety and Innovation
Act" (aka PDUFA)
 “Not later than 2 years after the date of
enactment of this Act, the Secretary of Health
and Human Services shall issue guidance that
describes Food and Drug Administration policy
regarding the promotion, using the Internet
(including social media), of medical products
that are regulated by such Administration.”
FDA's "Social Media Guidance Cliff"
New Deadline is July 2014
As of 30 May 2013, no “actions
completed” reported in FDASIA-TRACK

7. © 2013 Pharmaguy
Accountability
For what online communications are manufacturers, packers, or distributors accountable? In
particular, when should third-party discussions be treated as being performed by, or on behalf of,
the companies that market the product, as opposed to being performed independent of the
influence of the companies marketing the products?
 When marketer or agent sponsors the
discussion (e.g., provides a specific
grant to independent 3rd-party host
such as a patient advocacy group to
sponsor the discussion)
 When marketer or agent paid for the
content (e.g., paid patients for
testimonials or otherwise provided
compensation)
 When marketer or agent paid for
display ads to be run on specific
discussion pages (e.g., only
discussions related to the product
advertised)
3rd-Party Independence
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8. © 2013 Pharmaguy
Accountability: Best Practices
 DISCLOSURE of involvement with or influence over 3rd-party social media content
should be prominently displayed alongside relevant content when possible.
 Half of survey respondents agree
 Each company should have a Public Social Media Policy (SMP) that includes a notice
of its transparency/disclosure and other policies relating to social media. [Just like every
pharma company has a public privacy policy that applies to all its product Web sites,
each pharma company should have a public SMP that applies to all its social media
activities, whether owned or sponsored by the company.]
 About two-thirds of survey respondents agree
 Companies should monitor social media sites for unauthorized use or modification of its
approved content and make a best effort to remove or correct the content. But they
should only be REQUIRED to do so only for sites owned or directly sponsored by them.
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9. © 2013 Pharmaguy
Parameters for Correcting Misinformation
Are there any parameters or criteria that could be used to determine the appropriateness of
correcting misinformation and/or scope of information a company can provide when trying to
correct misinformation on a Web site outside a company's control?
 ONLY misinformation of real and imminent
danger to the public health (to be
determined by company) should be
corrected
 ALL off-label claims—even if supported
by peer-reviewed medical literature—
should be corrected)
 Only off-label claims NOT substantiated
by peer-reviewed medical literature should
be corrected
 Companies should not be burdened by
FDA regulations requiring them to make
corrections about ANY product
misinformation published on 3rd-party sites
Posting Corrective Information
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Should Pharma Edit Drug Articles on Wikipedia?
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What challenges are presented in handling adverse event information from these sources?
 The amount of information from these
sources is potentially too vast to be
processed economically (lack of resources)
 Finding adverse event information from these
sources is like finding a needle in a haystack
(too daunting)
 The information is usually incomplete and
does not meet the requirements for
submitting a meaningful AER (not
actionable)
 There are many potential issues that won't
fully be known until the practice of monitoring
social media for AEs is more prevalent
(unknown issues)
Adverse Event Reporting
Social Media Adverse Event Challenges

12. © 2013 Pharmaguy
“UCB has an ethical and legal responsibility to report adverse events associated
with our drugs. If adverse events for any UCB drugs are mentioned on the site,
UCB is required to report these directly to the U.S. Food and Drug Administration
(FDA). Therefore, we are working to develop and deploy a solution that will allow
us to assess and process potential adverse events, report them to the FDA, and
capture them in the UCB safety database.” -- Peter Verdru, MD, UCB’s Vice
President of Clinical Research
 Goal: Generate patient-reported outcomes that may help
UCB better understand how patients live with epilepsy
and help advance epilepsy care.
 Provides disease tracking tools
 Deployed a system for reporting adverse events to FDA
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UCB Embraces Adverse Events on Sponsored
PatientsLikeMe Epilepsy Discussion Board
June 16, 2009

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 13 June 2011: ABPI Pharmacovigilance Expert Network (PEN)
published “Guidance Notes” on management of AEs on pharma
owned/sponsored Websites; AEs should be collected and
documented, regardless of seriousness of event and whether or not
there is an identifiable reporter (http://bit.ly/BritAEguide)
 1 April 2011: PMCPA issued “informal guidance” for applying its
Code to social media; e.g., communication with physicians via
Twitter, corrections to Wikipedia, appropriate use of metadata
(http://bit.ly/PMBBritsvFDA)
EU Online AE Reporting & Twitter Guidance

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December 27, 2011
 Section VI addresses responding to unsolicited
requests on public forums such as the Internet
and "emerging electronic media”
 Cites cases on YouTube, blogs, and Twitter:
Pharma should respond to unsolicited requests
via private channels
 “FDA recommends that sales and marketing
personnel have no input on the content of
responses to unsolicited questions or
requests for off-label information”
FDA Off-Label Guidance & Social Media

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Pharma is Overcoming Social Media Hurdles
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Pharma is Overcoming Social Media Hurdles
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Period I: 54%
Period II: 30%
Period I: 24%
Period II: 42%

17. © 2013 Pharmaguy
Sanofi-Aventis Vs. Patient on Facebook
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March 15, 2010
The pharmaceutical industry’s
worst fear was realized when a
“disgruntled patient” posted
multiple adverse event messages
and photos on the wall of a
Sanofi-Aventis Facebook page
(VOICES). The page did not
have comments turned off and
did not include any terms of use.

18. © 2013 Pharmaguy
Sanofi Didn’t Give Up on Facebook
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August 11, 2011
“Likes” have grown from 522 in January 2011 to over 6,700 in June 2013.
“Since we operate in a heavily regulated
industry, we… must preview all messages.”
“While some messages may not be posted,
we are listening and encourage you to
continue sharing.”
Sanofi US Diabetes Won the 2012
Pharmaguy Social Media Pioneer Award

19. © 2013 Pharmaguy
I called this tweet
“Sleazy Twitter Spam”
Challenge (US): How to fit
benefits and fair balance in 140
characters or less?
Challenge (Globally): How to
make it meaningful for patients
We’re Still Friends!
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First (& Only?) Pharma Rx Branded Tweet!
June 18, 2009

20. © 2013 Pharmaguy
First (& Last?) Live Pharma Twitter Chat
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February 16, 2011
AstraZeneca hosted a one-hour chat on Twitter to raise awareness about helping patients save
money through prescription savings programs.
Tony Jewell, AZ, won the 2011 Pharmaguy
Social Media Pioneer Award

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December 13, 2011
 The Prescription Medicines Code of Practice Authority
(PMCPA) ruled Allergan breached the Code on several counts
after an employee accidentally tweeted publicly about Botox
 Employee violated Allergan’s "Global Social Media Policy”
that clearly stated "no Allergan employee might comment in a
social media forum about Allergan products or business
activity."
 Should pharmacos make their SM policies public to be more
transparent & accountable?
Pharma Employee Tweet Problem

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 A promise to visitors of SM sites you own or sponsor about how
YOU will behave, not how you expect THEM to behave
 Think of it as serving a similar purpose as your privacy policy
 Includes:
 Your comment moderation policy; this requires more details
than what has been seen to date
 Rules for participation by your employees (reflects the internal
policy that your employees are trained on)
 Rules for participation by agents of your company (should be
same as apply to your employees; trained on also)
 Other “rules of engagement”; e.g., correction of misinformation
Thoughts on an Outward-Facing SM Policy

23. © 2013 Pharmaguy
What's Your Social Media Implementation Plan?
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24. © 2013 Pharmaguy
Is This the Typical Mobile Health App Developer
Hired by Pharma?
Easy entry into mHealth offers
incredible opportunity for innovation
in healthcare; however, the open
market comes with certain concerns,
namely, “how credible are the apps I
am (or my patients are) using?”
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 Are
developers
knowledgeable
about
applicable
regula:ons,
laws,
and
pharma
sensibili:es?

25. © 2013 Pharmaguy
FDA Mobile Medical Apps “Scope of Oversight”
Pyramid
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26. © 2013 Pharmaguy
An Obvious MMA Subject to FDA Regulation
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 uChek
Urine
analyzer,
which
is
intended
for
use
with
reagent
strips
(e.g.,
Bayer
Dias:x)
for
the
qualita:ve
determina:on
of
urine
analytes
including
glucose,
urobilinogen,
pH,
ketone,
blood,
protein,
bilirubin,
nitrite,
leukocyte,
and
specific
gravity.
 Company
received
“It
Has
Come
to
Our
APen:on”
lePer
from
the
FDA
reques:ng
a
“clearance
number.

27. © 2013 Pharmaguy
Undocumented & Untested(?) Pharma MMAs
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 Psoriasis
app
by
Janssen
includes
a
“PASI”
(Psoriasis
Area
and
Severity
Index)
calculator
 No
cita:on
of
source
used
to
perform
calcula:on
–
was
it
the
equa:on
above?
 No
disclaimer
such
as
"Persons
using
the
data
within
for
medical
purposes
should
not
rely
solely
on
the
accuracy
of
the
data
herein.”
 Was
the
app
tested
and
cer:fied
by
a
third-­‐party?
 Is
this
an
“MMA”
subject
to
FDA
regula:on?

28. © 2013 Pharmaguy
The First Ever “Dear Doctor” Letter Regarding a
Mobile Medical App Recall
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 Pfizer
Rheumatology
Calculator
 Most
downloaded
app
tracked
by
POCKET.MD
(5-­‐Star
user
ra:ng)
 Recalled
via
a
“Dear
Doctor”
LePer
in
October
2011
because
of
"a
bug
in
the
app
...
gives
wrong
results.”

29. © 2013 Pharmaguy
More Mobile Health App Guidance from FDA for
Pharma to Worry About
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Standalone Clinical Decision Support (CDS)

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Reigning in the “Wild West” of Mobile Health Apps
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 Inaccurate
Health
Apps
 Good
App
Privacy
Prac:ces
 Test
and
Document
 Cer:fica:on
of
Mobile
Health
Apps
 Industry
Self-­‐Regula:on

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Pharma Mobile Apps Survey Results
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More Survey Results
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How concerned are you that
current draft FDA regulatory
guidelines will inhibit pharma
companies from developing
mobile health apps for
consumers and physicians?
 77%
agree
that
it
is
in
the
drug
industry's
best
interest
to
police
itself
and
develop
best
prac:ces
or
self-­‐
regulatory
guidelines

33. © 2013 Pharmaguy
Self- Regulation of Pharma Mobile Health Apps
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 The
pharmaceu:cal
industry
must
police
itself
with
regard
to
development
of
medical
apps;
e.g.,
Issue
“Guidelines
for
Mobile
Health
Apps
Developed
by
the
Pharmaceu:cal
Industry.”
Some
suggested
guidelines,
include:
 Apps
should
cite
the
source
of
the
data
used
by
the
app
and
include
contact
informa:on
for
repor:ng
errors.
Call
this
a
“Mobile
App
Adverse
Event
Repor:ng
&
Tracking”
system.
 Apps
must
be
rigorously
tested
&
cer:fied
by
a
third-­‐party
to
ensure
quality
and
accuracy.
 Apps
should
include
appropriate
disclaimers
and
terms
of
use
that
the
user
MUST
agree
to
before
the
app
will
run.

34. © 2013 Pharmaguy
 Social Media Pharma Marketing Readiness Self-Assessment --
http://bit.ly/SMreadiness
 Pharma Mobile Health App Best Practices Survey --
http://bit.ly/ByMobile
 Overcoming Space Limitations in Social Media;
http://bit.ly/fdasmSpace Use code ‘FDA397’ to get it FREE!
 Accountability for Pharma Content on Social Media Sites;
http://bit.ly/fdasmAcct Use code ‘FDA497’ to get it FREE!
 Solving the Social Media Adverse Event Reporting Problem;
http://bit.ly/fdasmAE Use code ‘AE495’ to get it FREE!
 Pharma is Overcoming Social Media Hurdles: Assessing the
Three Biggest Obstacles to Success; http://bit.ly/SMhurdles Use
code ‘SMhurdleFREE’ to get it FREE!
Resources
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35. © 2013 Pharmaguy
Thank You!
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