How to handle social media in pharma with care

Patrick MassadDeputy Commissioner

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,

Transparency

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

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:• 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 by July 1st, 2014

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

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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”

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Still unsure?

See “The Distinction Between Advertising and

Other Activities”on the Health Canada website

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 ?

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.

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

Common elements on social media platforms:

We’ll show several examples . Impossible to show all, but we’ll focus on those whose principles are most easily transferred to other tactics.

Note: Sometimes, the UGC area is not dedicated to the placement.

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”. http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2011-guidance-directrice_reporting-notification/index-eng.php

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).

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

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.

Another example

• Reader post on a sponsored blog about non-pharmacological 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.

Let’s differentiate

Creation of a platform for UGC

Advertising on an existing third party SM* platform

* SM = Social Media

Corporate or product site with UGC functionality

Somewhere in the middle

i.e. The content comes with a UGC area which is dedicated to that content

App stores

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)

Post-gate• All company/agent generated content

E.g. site rules/instructions, thread topics/questions, intra/inter site links, company/agent responses, fair balance

UGCOngoing 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

Czech Tec

Manufacturer not responsible for UGC

Somewhere in the middle

i.e. The content comes with a UGC area which is dedicated to that content

App stores

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, there are BIG differences in consumer rules & in responsibility for UGC versus the in the USA.