The Internet is now the premier source of healthcare information for physicians and consumers alike. Consequently, FDA-regulated companies have been leveraging it in various ways, but compliance has proven challenging and confusing for companies not accustomed to digital tactics. * Recent FDA enforcement actions that command the attention of anyone considering digital communication tactics * Trends in digital media consumption and their impact on advertising effectiveness * FDA’s 2009 Draft Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion * FDA’s 2011 Draft Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications *Some red flags guaranteed to draw FDA’s ire * The latest on FDA social media guidance

1. Compliant Promotion
in an On-Demand World
6 June 2013
Presented by
Dale Cooke
Vice President/Group Director, Regulatory Review

2. 2
Agenda
Changing Media Environment
Enforcement Environment
Digital Tactics
FDA on Social Media and the Internet
FDA on Mobile Apps
Key Takeaways

3. 3
Changing Media Environment: Consumers

4. 4
eMarketer TV, Web Vie for
Viewers’ Attention, March 2008
More than 75% of the US adult Internet
users went online while watching TV
In a typical week, how many hours do you spend doing each of the following?
Some of us are online more than we watch TV…
…and most of us go online while we watch TV
SOURCE: North American Technographics®
Benchmark Survey, 2009 - Consumers'
Behavior Online: A 2009 Deep Dive

5. 5
SOURCE: North American Technographics® Benchmark Survey, 2009 -
Consumers' Behavior Online: A 2009 Deep Dive
Consumers want — and have access to — more, faster
Americans are increasingly online
with broadband access
Online
Broadband
All US households
(millions)
0
20
40
60
80
100
120
140
2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

6. 6
Consumers are social
67%
20%
15%
16%
13%
6%
33%
0% 10% 20% 30% 40% 50% 60% 70% 80%
Facebook
LinkedIn
Pinterest
Twitter
Instagram
Tumblr
None
Pew Internet: Social Networking (full detail)
February 14, 2013

7. 7
Taking their online lives on the road

8. 8
Hours per week 0 5 10 15
Gen Yers (18-29)
Gen Xers (30-43)
Younger Boomers (44-53)
Older Boomers (54-64)
Seniors (65+)
Internet use, personal purposes
88% of online adults seek health info each year,
but for most it is a small part of their total online experience
10%
16%
25%
19%
13%
12%
4%
Daily > once
per week
2-3 times
per
month
Abt once
per
month
Every 2-3
months
2-3 times
a year
Yearly
Frequency of online health info seeking
Among all online adults
SOURCE: Forrester North American
Technographics Benchmark Survey, 2009:
Consumers' Behavior Online: A 2009 Deep Dive SOURCE: Manhattan Research, The Cybercitizen Health™ v8.0 (2008)

9. 9
Changing Media Environment: HCPs

10. 10
Physicians traditional reliance on reps is
rapidly waning
75%
18%
7%
Call Length
Most calls today end at the
sample closet
And one in four physicians
sees no reps at all
Only 55% of physicians find
information received in sales
calls valuable
SOURCE: Datamonitor, 2008
SOURCE: SK&A Information Services, 2009
SOURCE: Datamonitor, 2007
Zero < 2 Minutes ≥ 2 Minutes

11. 11
Doctors love their gadgets
Among all physicians
SOURCE: Taking the Pulse® v13.0 (2013)
More than
three-quarters
of physicians own a
smartphone
91%
88%
83%
80%
72%
0% 20% 40% 60% 80% 100%
Cellular or mobile phone
Desktop computer
Smartphone
Laptop
Tablet
Technology Devices Owned or Used

12. 12
In less than three years, iPad has already
established a strong beachhead
Physician Tablet Ownership
iPad
Other Tablet
None
iPad: 55%
None: 28%
Other:
17%
Source: ePharma Physician® v13.0 (2013)

13. 13
Physicians are online
…increasingly in the clinical setting
SOURCE: Taking the Pulse® v13.0 (2013)
Among tablet owners
And the iPad?
58%
56%
26%
23%
On weekends
Before or after work
Between patient
consultations
During patient
consultations
14%
10%
51%
12%
5%
9%
0%
10%
20%
30%
40%
50%
60%
None <1 hr 1-2 hrs 2-3 hrs 3-5 hrs >5 hrs
Time Spent Using Digital Resources
during a Typical Workday

14. 14
54%
17%
16%
10%
3%
3%
38%
0% 20% 40% 60%
Facebook
LinkedIn
Google+
Twitter
SoundCloud
Tumblr
None of these
Personal use
9%
24%
8%
3%
1%
0%
66%
0% 20% 40% 60% 80%
Facebook
LinkedIn
Google+
Twitter
SoundCloud
Tumblr
None of these
Professional Use
Doctors are social people …but not for work
SOURCE: Taking the Pulse® v13.0 (2013)

15. Enforcement Environment

16. 16
$8.7 billion in three years
The HEAT is on

17. 17
Bad Ad Program

18. 18
Increase in the number of reports of
violative promotional activities from HCPs 1
1SOURCE: FDA Bad Ad Program Year End Report, 2011
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/DrugMarketingAdvertisingandCommunications/ucm258719.htm
Was it successful?

19. 19
Future Expansion Planned

20. 20
Presenting Risk
Information Compliantly

21. 21
FDA is here to help
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInf
ormation/Guidances/UCM155480.pdf
Released May 2009

22. 22
FDA Considerations
> Materiality and Comprehensiveness
> Hierarchy of Risk Information
> Signaling
> Quantity Counts
> Framing

23. 23
FDA Considerations
Net Impression
Comparably
Prominent

24. Draft Guidance in Practice

25. 25
Email for Voltaren from Novartis
Date: April 14, 2010
Violations:
> Minimization of risk information
> Overstatement of efficacy
> Broadening of indication
Lessons:
> Reasonably comparable presentation explicated
> Segregation of risk information

26. 26
Email for Voltaren from Novartis
Date: April 14, 2010
Violations:
> Minimization of risk information
> Overstatement of efficacy
> Broadening of indication
Lessons:
> Reasonably comparable presentation explicated
> Segregation of risk information
Benefit
Risk

27. 27
Email for Voltaren
from Novartis

28. 28
Sales Aid for Durezol
from Sirion Therapeutics
Date: February 18, 2010
Violations:
> Minimization of risk information
> Overstatement of efficacy
Lessons:
> Reasonably comparable
presentation explicated
> Segregation of risk information
discouraged
> Include risk information
in all parts

29. Conversion from
Disease Awareness to Product Information

30. 30
Journal Ad for Arzerra
from GlaxoSmithKline
Date: April 15, 2010
Violations:
> Didn’t submit pre-approval
> Didn’t submit 2253
> Didn’t include risk information
Lessons:
> Heightened scrutiny for all
promotional efforts for subpart H
products
> Mere omission of a drug name does
not automatically make a piece
“unbranded”
> Use of a redirect URL does not
ensure compliance

31. Patient Testimonials

32. 32
Patient Video for Herceptin
from Genentech
Date: March 26, 2010
Violations:
> Minimization of risk information
> Overstatement of efficacy
Lessons:
> Reasonably comparable presentation
explicated
> Segregation of risk information
> Minimal risk information in “body” of
video does NOT suffice
> Pre-scroll of risk information does NOT
suffice

33. 33
Patient Video for Adcirca
from Eli Lilly
Date: January 1, 2010
Violations:
> Overstatement of efficacy
Lessons:
> Patient descriptions of their condition
can expand indication and overstate
efficacy
> Ensure patient experience fall within
clinical results

34. Social Media

35. 35
Atelvia Video
from Warner Chilcott
Date: May 5, 2011
Violations:
> Omission of risk information
> Didn’t submit 2253
> Misleading claims
Lessons:
> EVERYONE needs a Social Media Policy
> Must include risk information with the
benefit claims

36. 36
Facebook Sharing for
Tasigna from Novartis
Date: July 29, 2010
Violations:
> Unsubstantiated superiority claim
> Didn’t submit 2253
> Didn’t include risk information
Lessons:
> Social media is OK if done correctly
> Subpart H does NOT restrict content or
media
> FDA advisory comments can be
ignored, but doing so increases your
risk of enforcement later

37. 37
FDA on Social Media
and the Internet

38. 38
Nov ’09 Part 15 Hearings & FDASIA
Five questions from part 15 hearings
> What online communications are sponsors
responsible for?
> How can sponsors fulfill obligations in
space-limited contexts?
> What should sponsors do about corrective
messaging?
> When are links appropriate?
> How should sponsors deal with AERs?
FDASIA mandate to produce guidance by July 2014

39. 39
What NOT to Expect
> Overturning previous enforcement actions
• One-click rule is well and truly dead
> Creation of new regulations
> Exemptions from existing regulations

40. 40
What Might be Included
> Discussion of the Adequate Provision
Requirement in Space-Limited Formats
> Something akin to the “major statement”
requirement for broadcast advertising
> Elaboration of what constitutes material
risk information

41. 41
Mobile Apps

42. 42
Medical DevicesAdvertising & Promotion
What is this thing?

43. 43
FDA is here to help
http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidan
cedocuments/ucm263280.htm
Released July 2011

44. 44
MMA guidance
Mobile Medical App (MMA) defined as:
“When the intended use of a mobile app is for the
diagnosis of disease or other conditions, or the
cure, mitigation, treatment, or prevention of
disease, or is intended to affect the structure or
any function of the body of man, the mobile app is
a device.”
— Draft Guidance, Mobile Medical Applications, page 8

45. 45
Apps FDA intends to regulate as devices
> Accessories to a regulated medical device
> Apps transforming the mobile device into a medical
device
> “input patient-specific information and…output a
patient-specific result, diagnosis, or treatment
recommendation to be used in clinical practice or to
assist in making clinical decisions”
— Draft Guidance, Mobile Medical Applications, page 14

46. 46
Final guidance due
“in the coming weeks”—March 21, 2013
Christy Foreman,
Director of the Office of Device
Evaluations, CDRH

47. 47
But what about mobile promotion?
Unique considerations for mobile promotion
> Device size
> Device variability
> Screen rotation
> Technology changes (Go away, Flash!)
> Screen takeover
> Touch screen interface
> Integration with the rest of the device (GPS,
calendar, reminders, etc.)

48. 48
Key Takeaways

49. 49
While we’re waiting…
Avoid segregation of risk information
> Integrate the risk information into the body of the material
> Don’t relegate the information to the footer or the back
Ensure the risk information is presented in a reasonably
comparable manner to the benefit information
> Benefit in audio, risk in audio
> Benefit in large font, risk in large font
Don’t distract from the risk information
Make sure claims fall within the broad experience of the
clinical trials
> Avoid outliers in your studies as your patient testimonials
Assume draft guidance represents FDA’s current position
Any guidance will NOT change the rules

50. Questions?
Dale Cooke
Vice President/Group Director, Regulatory Review
Dale.Cooke@DigitasHealth.com
@PhillyCooke on Twitter
www.scribd.com/Dale_Cooke

51. 51
Dale Cooke
VP/Group Director, Regulatory Review
Dale Cooke is the head of the Regulatory Review department for Digitas
Health. He has worked with more than 25 pharmaceutical and medical
device clients and with Medical-Legal-Regulatory committees around the
world from offices in Philadelphia, New York, Boston, and London. Dale
advises clients on FDA enforcement actions and provides recommendations
for compliance with FDA regulations, with a focus on issues involving the
Internet and emerging technology. His insights have been featured in the
Wall Street Journal’s Health blog, The Pink Sheet, MedAdNews, PharmExec,
and others. Dale is a member of the Regulatory Affairs Professionals Society
(RAPS) and the Food and Drug Law Institute (FDLI).
Dale is the author of Effective Review and Approval of Digital Promotional
Tactics, which is part of the FDLI primer series. He is regularly invited to
speak at industry conferences on topics including FDA enforcement trends,
best practices for review processes, global review practices, and
pharmaceutical involvement in social media.
Dale earned his B.A. in Philosophy from Southern Methodist University and
an M.A. in Analytical Philosophy from the University of Arizona and studied
Epidemiology and Biostatistics at Drexel University’s School of Public Health.
Before joining Digitas Health, Dale was with ARAMARK overseeing proposal
development for government and industry clients.