Section 6.5 of the PAAB code was modernized by this group (comprised largely of industry). They also created the “online activities”
Input was then obtained broadly across many stakeholders
First. Let’s talk about this.
As suggested here, the frame work has multiple parts.
Great. So we’ve built our framework (including paths in and out). How about the stuff that registrants will contribute to fill that framework??
You generated the video. That’s why the chat room exists. You are responsible for the chat. But like the facebook profile banner, you need to be careful about tags. Some one else posts it, no problem. It you could disable chat, no problem
If this would be a relevant point of discussion for you, raise it in the panel discussion.
How to handle social media in pharma with care by Patrick Massad
How to handle social media
in pharma with care
Trusted healthcare product communication that promotes optimal health
To provide a preclearance review that fosters trustworthy healthcare
communications within the regulatory framework for the benefit of all
Integrity, Competency, Credibility, Independence, Excellence, Transparenc
How does PAAB review digital?
PAAB code section 6.5 (revamped in last code
Also see guidance documents in the resource
section of www.paab.ca
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
Draft code input from:
• Medical associations
• Health Canada
• Selected patient organizations
New code (5th draft of revised code):
– Implemented July 1st, 2013
– Transition period (almost over)
– Full implementation by July 1st, 2014
The advertising provisions in the
Act, Regulations, and the PAAB code applies
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”
“The Distinction Between Advertising and
on the Health Canada website
The Distinction Between Advertising and Other Activities:
• What is the context in which the message is
• 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 ?
The Distinction Between Advertising and Other
“No one factor in itself will determine
whether or not a particular message is
…If uncertain, don’t hesitate to ask PAAB.
We’ll respond to requests for written opinions within
Drug-related social media activities
tend to fall in one of these buckets:
– Product Branded advertising
– Unbranded (i.e. editorial) advertising
– Information (not advertising)
E.g. consumer brochure websites
Third party site/platform
Common elements on social media
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.
3 key questions
• What am I required to monitor?
• How frequently?
• When/how am I required to intervene?
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”.
Drug called Wapple
• Indication: Used post-MI to prevent a second
• Three dosage strengths: 50mg OD, 100mg
OD, 15mg OD
• Most frequent side effect: Diarrhea
• Cannot be absorbed if ingested with calcium (due
Video which positions Wapple as
a treatment for constipation was
placed on the Wapple website.
Is this okay if :
• Generated by company?
• It is UGC?
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
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.
• 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
Corrections should be timely. They do not require preclearance.
Stick to minimum required to address the issue.
Creation of a platform
product site with
Advertising on an existing
third party SM* platform
* SM = Social Media
Somewhere in the middle
i.e. The content comes with a UGC area which is dedicated to that content
Let’s start with…
Creation of a platform
product site with
What does PAAB review for manufacturer
controlled/influenced sites which have UGC functionality?
• Landing page
• Promotion (e.g. banner ads, SEM, SEO, app description)
Gating Mechanism (if required)
• All company/agent generated content
E.g. site rules/instructions, thread
topics/questions, intra/inter site links, company/agent
responses, fair balance
It is critical to apply local
regs to pharma generated
content and to approach
For example, there are
BIG differences in
consumer rules & in
responsibility for UGC
versus the in the USA.