OPMA session March 6, 2014

1. How to handle social media
in pharma with care
Patrick Massad
Deputy Commissioner

4. PAAB
VISION
–
Trusted healthcare product communication that promotes optimal health
MISSION
–
To provide a preclearance review that fosters trustworthy healthcare
communications within the regulatory framework for the benefit of all
stakeholders.
VALUES
–
Integrity, Competency, Credibility, Independence, Excellence, Transparenc
y

5. How does PAAB review digital?
PAAB code section 6.5 (revamped in last code
review)
Also see guidance documents in the resource
section of www.paab.ca

6. Online Committee Members:
– Ray Chepesiuk (Chair)
– Joanne Skedelsky, Pfizer (at the time)
– Deirdre Cozier, Sanofi
– Christian Otte, Amgen
– Alex France, Brightworks
– Brad Einarsen, Klick
– Fiona Birch, Tonic Global
– Patrick Massad, PAAB

7. Draft code input from:
• Industry
• Formularies
• Medical associations
• Health Canada
• Selected patient organizations

8. New code (5th draft of revised code):
– Implemented July 1st, 2013
– Transition period (almost over)
– Full implementation by July 1st, 2014

9. The advertising provisions in the
Act, Regulations, and the PAAB code applies
to…

10. What is Drug Advertising?
Definition in section 2 of the Food & Drugs Act:
“Any representation by any means whatever
for the purpose of promoting directly or
indirectly the sale or disposal of any
food, drug, cosmetic or device”
10

11. Still unsure?
See
“The Distinction Between Advertising and
Other Activities”
on the Health Canada website
11

12. The Distinction Between Advertising and Other Activities:
• What is the context in which the message is
disseminated ?
• Who are the primary and secondary audiences ?
• Who delivers the message (the provider) ?
• Who sponsors the message and how ?
• What influence does the drug manufacturer have on the
message content ?
• What is the content of the message ?
• With what frequency is the message delivered ?

13. The Distinction Between Advertising and Other
Activities continued:
“No one factor in itself will determine
whether or not a particular message is
advertising.”
…If uncertain, don’t hesitate to ask PAAB.
We’ll respond to requests for written opinions within
4 days.

14. Drug-related social media activities
tend to fall in one of these buckets:
Pharma generated/influenced
– Product Branded advertising
– Unbranded (i.e. editorial) advertising
– Information (not advertising)
E.g. consumer brochure websites
Third party site/platform

15. Common elements on social media
platforms:
Note: Sometimes, the UGC area is
not dedicated to the placement.
We’ll show several examples . Impossible to show all, but we’ll focus on
those whose principles are most easily transferred to other tactics.

16. 3 key questions
• What am I required to monitor?
• How frequently?
• When/how am I required to intervene?

17. Monitoring: When required, it’s frequency
based on volume & nature of UGC
Remove off-label UGC
Remove or correct (i.e. corrective post) misinformation
which has potential to harm (e.g. patients, company…)
Report adverse Reactions*
*In accordance with the Health Canada guidance document “Reporting Adverse
Reactions to Marketed Health Products”.
http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2011-guidancedirectrice_reporting-notification/index-eng.php

18. Drug called Wapple
• Indication: Used post-MI to prevent a second
heart attack
• Three dosage strengths: 50mg OD, 100mg
OD, 15mg OD
• Most frequent side effect: Diarrhea
• Cannot be absorbed if ingested with calcium (due
to chelation).

20. Video which positions Wapple as
a treatment for constipation was
placed on the Wapple website.
Is this okay if :
• Generated by company?
No
• It is UGC?
No

21. Is intervention necessary?
• Post: “I took my Wapple with me when I
visited the capital of Canada, Toronto”.
No. Since no health/legal/competitive hazard

22. Example of correction
• Post: “It’s unfortunate that there are only 2
doses available in Canada. 100 mg and 150mg.
Does this company think our patients are
Titans or something??
[Company badge]: Wapple is available in
50mg, 100mg, and 150mg tablets. Please click
here for the product monograph.

23. Another example
• Reader post on a sponsored blog about nonpharmacological tips for patients on Wapple:
“I take my tablet with a huge glass of cow’s milk. I
have not had diarrhea since starting this”.
[company badge]: Please note that the product
insert advises not to take Wapple with foods and
drinks which are high in calcium (e.g. such as cow’s
milk). This can prevent the drug from getting
absorbed into the body. Please click here for the
product insert.
Corrections should be timely. They do not require preclearance.
Stick to minimum required to address the issue.

24. Let’s differentiate
Creation of a platform
for UGC
Corporate or
product site with
UGC functionality
Advertising on an existing
third party SM* platform
* SM = Social Media

25. Somewhere in the middle
App stores
i.e. The content comes with a UGC area which is dedicated to that content

26. Let’s start with…
Creation of a platform
for UGC
Corporate or
product site with
UGC functionality

27. What does PAAB review for manufacturer
controlled/influenced sites which have UGC functionality?
The
framework

28. Framework
Pre-gate
• Landing page
• Promotion (e.g. banner ads, SEM, SEO, app description)
Gating Mechanism (if required)
Post-gate
• All company/agent generated content
E.g. site rules/instructions, thread
topics/questions, intra/inter site links, company/agent
responses, fair balance

30. UGC
Ongoing
monitoring
by the
manufacturer

31. Manufacturer
responsible
for UGC

32. Manufacturer
responsible for
UGC

33. Advertising on an existing
third party SM* platform
* SM = Social Media

34. Facebook ad
Manufacturer not
responsible for UGC
Czech Tec

35. Somewhere in the middle
App stores
i.e. The content comes with a UGC area which is dedicated to that content

36. Samsung
Play Store
Manufacturer
responsible for UGC

37. Manufacturer
responsible for UGC

38. LinkedIn Group
Common question:
Is the user’s profile sufficient validation of HCP
status?
Nope.

39. A word on localization

40. Localization:
It is critical to apply local
regs to pharma generated
content and to approach
toward UGC.
For example, there are
BIG differences in
consumer rules & in
responsibility for UGC
versus the in the USA.