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How to handle social media
in pharma with care

Patrick Massad
Deputy Commissioner
PAAB
VISION
–

Trusted healthcare product communication that promotes optimal health

MISSION
–

To provide a preclearance...
How does PAAB review digital?
PAAB code section 6.5 (revamped in last code
review)
Also see guidance documents in the reso...
Online Committee Members:
– Ray Chepesiuk (Chair)
– Joanne Skedelsky, Pfizer (at the time)
– Deirdre Cozier, Sanofi
– Chri...
Draft code input from:
• Industry
• Formularies
• Medical associations
• Health Canada
• Selected patient organizations
New code (5th draft of revised code):
– Implemented July 1st, 2013
– Transition period (almost over)
– Full implementation...
The advertising provisions in the
Act, Regulations, and the PAAB code applies
to…
What is Drug Advertising?
Definition in section 2 of the Food & Drugs Act:
“Any representation by any means whatever
for t...
Still unsure?

See
“The Distinction Between Advertising and
Other Activities”
on the Health Canada website

11
The Distinction Between Advertising and Other Activities:

• What is the context in which the message is
disseminated ?
• ...
The Distinction Between Advertising and Other
Activities continued:

“No one factor in itself will determine
whether or no...
Drug-related social media activities
tend to fall in one of these buckets:
Pharma generated/influenced
– Product Branded a...
Common elements on social media
platforms:

Note: Sometimes, the UGC area is
not dedicated to the placement.
We’ll show se...
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. co...
Drug called Wapple
• Indication: Used post-MI to prevent a second
heart attack
• Three dosage strengths: 50mg OD, 100mg
OD...
Video which positions Wapple as
a treatment for constipation was
placed on the Wapple website.
Is this okay if :
• Generat...
Is intervention necessary?
• Post: “I took my Wapple with me when I
visited the capital of Canada, Toronto”.
No. Since no ...
Example of correction
• Post: “It’s unfortunate that there are only 2
doses available in Canada. 100 mg and 150mg.
Does th...
Another example
• Reader post on a sponsored blog about nonpharmacological tips for patients on Wapple:
“I take my tablet ...
Let’s differentiate
Creation of a platform
for UGC
Corporate or
product site with
UGC functionality

Advertising on an exi...
Somewhere in the middle

App stores

i.e. The content comes with a UGC area which is dedicated to that content
Let’s start with…
Creation of a platform
for UGC
Corporate or
product site with
UGC functionality
What does PAAB review for manufacturer
controlled/influenced sites which have UGC functionality?

The
framework
Framework
Pre-gate
• Landing page
• Promotion (e.g. banner ads, SEM, SEO, app description)
Gating Mechanism (if required)
...
UGC
Ongoing
monitoring
by the
manufacturer
Manufacturer
responsible
for UGC
Manufacturer
responsible for
UGC
Advertising on an existing
third party SM* platform
* SM = Social Media
Facebook ad

Manufacturer not
responsible for UGC

Czech Tec
Somewhere in the middle

App stores

i.e. The content comes with a UGC area which is dedicated to that content
Samsung
Play Store
Manufacturer
responsible for UGC
Manufacturer
responsible for UGC
LinkedIn Group
Common question:
Is the user’s profile sufficient validation of HCP
status?
Nope.
A word on localization
Localization:
It is critical to apply local
regs to pharma generated
content and to approach
toward UGC.
For example, ther...
How to handle social media in pharma with care by Patrick Massad
How to handle social media in pharma with care by Patrick Massad
How to handle social media in pharma with care by Patrick Massad
How to handle social media in pharma with care by Patrick Massad
How to handle social media in pharma with care by Patrick Massad
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How to handle social media in pharma with care by Patrick Massad

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OPMA session March 6, 2014

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  • 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.
  • Transcript of "How to handle social media in pharma with care by Patrick Massad"

    1. 1. How to handle social media in pharma with care Patrick Massad Deputy Commissioner
    2. 2. 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
    3. 3. 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
    4. 4. 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
    5. 5. Draft code input from: • Industry • Formularies • Medical associations • Health Canada • Selected patient organizations
    6. 6. New code (5th draft of revised code): – Implemented July 1st, 2013 – Transition period (almost over) – Full implementation by July 1st, 2014
    7. 7. The advertising provisions in the Act, Regulations, and the PAAB code applies to…
    8. 8. 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
    9. 9. Still unsure? See “The Distinction Between Advertising and Other Activities” on the Health Canada website 11
    10. 10. 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 ?
    11. 11. 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.
    12. 12. 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
    13. 13. 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.
    14. 14. 3 key questions • What am I required to monitor? • How frequently? • When/how am I required to intervene?
    15. 15. 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
    16. 16. 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).
    17. 17. 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
    18. 18. 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
    19. 19. 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.
    20. 20. 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.
    21. 21. 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
    22. 22. Somewhere in the middle App stores i.e. The content comes with a UGC area which is dedicated to that content
    23. 23. Let’s start with… Creation of a platform for UGC Corporate or product site with UGC functionality
    24. 24. What does PAAB review for manufacturer controlled/influenced sites which have UGC functionality? The framework
    25. 25. 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
    26. 26. UGC Ongoing monitoring by the manufacturer
    27. 27. Manufacturer responsible for UGC
    28. 28. Manufacturer responsible for UGC
    29. 29. Advertising on an existing third party SM* platform * SM = Social Media
    30. 30. Facebook ad Manufacturer not responsible for UGC Czech Tec
    31. 31. Somewhere in the middle App stores i.e. The content comes with a UGC area which is dedicated to that content
    32. 32. Samsung Play Store Manufacturer responsible for UGC
    33. 33. Manufacturer responsible for UGC
    34. 34. LinkedIn Group Common question: Is the user’s profile sufficient validation of HCP status? Nope.
    35. 35. A word on localization
    36. 36. 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.
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