PAAB Offers Guidance on Regulatory Social Media Thought Process

Eye for Pharma organized the 1st eMarketing Canada conference, which was held in Toronto, on November 1-2 2010.

Patrick Massad (Chief Review Officer at the PAAB, Pharmaceutical Advertising Advisory Board) presented an algorithm to facilitate the regulatory thought process when planning a social media promotional activity.  Here is the suggested algorithm:

1) Is this advertising?

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2) Who is the intended audience?

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3) What restrictions should I consider for this audience with respect to disease and product schedules?

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4) What mechanism will I use to limit access to that audience?

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5) What is the sponsor’s tolerance for uncertainty & risk?

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6) How will I align the site with this tolerance level?

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7) What are the regulatory consequences of adding and/or linking other tools/content to my site?

 

Here are some highlights of Patrick’s presentation with regards to the very 1st step to detemine if tactic in mind is advertising or not:

Health Canada’s definition of advertising is as follows:  “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” (as per section 2 of Food Drugs Act).

If this does not help to answer the question about whether the promotion is advertising or not, you can then refer to Health Canada’s policy document “The Distinction Between Advertising and Other Activities”, which lists the following 7 questions:

•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?

By answering these questions, the intent of the promotion becomes clearer as to whether the tactic is advertising or informational.

The intented audience and type of drug will determine which regulatory body needs to be consulted.  See this article here if you need assistance to determine which Canadian regulatory body to consult for your promotional campaign.

For more information about PAAB guidelines regarding social media, see Highlights from “Social Media Marketing in Pharma: What Works in Canada”

What do you think of this algorithm?  Would you add, delete or change any of the suggested steps?  Please leave a comment below.

Stay in touch,
Natalie

Connect with me on the following networks:
FaceBook, Twitter, LinkedIn

The 1st Canadian Pharma Ad on FaceBook?

A brave Canadian pharmaceutical company has taken the plunge and is giving FaceBook direct-to-consumer (DTC) advertising a try. King Pharmaceuticals has been promoting its EpiPen.ca website via the following English and French FaceBook ads:

The call-to-action is to take the allergy risk test, but it appears as though the main objective of the site itself is to introduce the new EpiPen and EpiPen Jr (0.3 and 0.15 mg epinephrine) Auto-injectors (“EpiPen”) to Canadian consumers and healthcare professionals.  Both the FaceBook ads and the site are DTC advertising.

Although King Pharmaceuticals launched the new EpiPen and EpiPen Jr Auto-Injectors on April 14 2010, I first noticed the FaceBook ad on Monday May 10th 2010.  Of course, it is possible that the ad was launched sooner and that it just came to my attention later.

Can a prescription Rx brand copy this social media model?

EpiPen falls under “ethical pharmaceuticals” in the regulatory system.  However, it is not a schedule F product (prescription required for sale).  Therefore, section c01.044 of Canada’s Food and Drug Regulations Act (which limits pharmaceutical DTC advertising to only product name, price, quantity) does not apply.  To promote a prescription product (Schedule F) in a FaceBook ad (DTC), only the product name, price and quantity would be allowable because it is a public direct-to-consumer placement.  Since the PAAB approves campaigns as a whole, this would also apply to any website that the FaceBook ad would link to.  For more information about Canadian regulatory requirements for prescription products promoted in social media, see Highlights from “Social Media Marketing in Pharma: What Works in Canada” or contact Patrick Massad at the PAAB.  If you are interested in learning more about Canadian regulatory guidelines for other types of healthcare products, you might like this article.

Is this the first Canadian pharma ad on FaceBook?

As far as the ads that I have seen on my personal FaceBook profile, this is the first one that I have seen from a Canadian pharmaceutical company.  There may have been others.  I might have missed them, or perhaps I was not part of the target market for the ad.  So unless somebody tells me otherwise, I do believe that this is the very first branded FaceBook ad by a Canadian pharmaceutical company.  In fact, I have not seen an unbranded FaceBook ad by any Canadian pharma companies.  I you know of others, then please share in the comments section.

Is the FaceBook ad driving traffic to the EpiPen.ca website?

Since the EpiPen FaceBook ad seems to have the objective of driving unique visitor traffic to the EpiPen.ca website, it is reasonable to track traffic to the site as an ROI measurement.  As an outsider, I will use data from Alexa and Compete. The following data and snapshot were taken on May 12 2010:

• Alexa traffic rank as of May 12 2010 is 1,562,812
• Alexa traffic rank in Canada is 27,244.
• 1,177 monthly unique visitors to the website in February 2010.

In a few months, I’ll take another look at the data from these two sources to see if the website gets a peak in their traffic.  This could create some interesting discussion.  Stay tuned !!

Congratulations to King Pharmaceuticals for taking this innovative step.

Stay in touch,
Natalie

Connect with me on the following networks:
FaceBook, Twitter, LinkedIn

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FaceBook Healthcare-Related Ads, Plus 2 from Pharma (March 8-21 2010)

Here is my latest post with various FaceBook healthcare-related ads that were targeted to my profile from March 8-21 2010.  Finally, there were a couple of ads from pharma companies.  One (from the U.S.), which is looking for job applicants, and the other (from Chile), which appears to be trying to sell their products in other countries.  It’s a start!

Previous posts on FaceBook healthcare-related ads:

• from Feb 6-18 2010 here
• from Jan 25 to Feb 5 2010 here
• from Feb 19 to Mar 7 2010 here

I also found an interesting healthcare-related ad on YouTube.  Since I do not see healthcare-related ads very often on YouTube, hence no need to start a new category, I decided to add it to this post.

Obviously there are many more of these types of ads on FaceBook, but these are the ones that have appeared on my specific profile.  This is by no means an endorsement of any of the products or services depicted, nor is it a critique of the ads themselves.

Feel free to critique any of these FaceBook (or YouTube) healthcare-related ads in the comments section.

Stay in touch,
Natalie

Connect with me on the following networks:
FaceBook, Twitter, LinkedIn

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To ensure that you receive all new updates to this blog, insert your e-mail address in the box in the top-right corner. Your e-mail will remain private and will not be shared with any third parties.

Here is the YouTube healthcare-related ad. The ad changes after a few seconds, so I took a snapshot of both the first and second part of the ad, hence the two pics on top of each other;

The following are all FaceBook healthcare-related ads, except for the one about running your own hospital.  That one is just an ad for an online FaceBook hospital game, but I thought some readers might find it interesting.  Enjoy!

Canadian Pharma/Healthcare Regulatory Guideline Revisions – Jan 2010

Love them or hate them, as a medical marketer, you have a ton of regulatory guidelines to follow.  And they seem to change on a regular basis (some guidelines change more frequently than others).  In this blog post, you will find a list of some of the Canadian healthcare guidelines with links that will lead you to the document(s) of interest. The only revisions that took place in January 2010 are in the Rx&D code (see below for details of these changes).  A few other revisions for other sets of guidelines are expected over the next couple of months.  Although the details on the other revisions have not been shared with me, I made a note of when the revisions are expected to take place.

NOTE: If you have marketing collaterals or campaigns that need pre-clearance, but you are not sure which regulatory body to contact, take a look at yesterday’s post; Algorithm on choosing the appropriate Canadian healthcare regulatory guidelines.

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New 2010 Rx&D Code of Ethical Practices (not yet posted on the Rx&D website, but coming soon). Here’s a peak at the upcoming changes.  Only section 15 has been revised in the 2010 code:

Section 15.4 Penalties

• In 2009, the 1st, 2nd and 3rd code infractions were published in the Rx&D Update.  As of 2010, these infractions will be published on the Rx&D website.  All postings will remain on the website for 24 months from the date of the final decision.

New section 15.4.1 Compliance Statement (3 statements as part of this new section)

• Within ninety (90) days of the final decision date with respect to any Code infraction, the Member must clearly indicate in writing to Rx&D that they have halted the activity or otherwise addressed the issue that caused the infraction. A copy of this compliance statement will be posted on the Rx&D website with the relevant decision of the IPRC.

• In the event that Rx&D determines that the Member has not complied with this requirement, the Member will be deemed to have deliberately contravened one of the Guiding Principles, and the penalties set out in Section 15.3, 15.5.1 and 15.5.2 will apply.

• In exceptional circumstances, a Member, acting in good faith, may believe that more than ninety (90) days will be required to comply with this Section 15.4.1. In this case, the Member must file a written extension request with Rx&D within ten (10) days of the decision date, providing a detailed supporting rationale for the request, and an estimate of the time required. Rx&D will forward the extension request to the IPRC who will evaluate the extension request and make a recommendation to the Rx&D Executive Committee (EC) within ten (10) days of its receipt. The EC, in its sole discretion, may elect to grant such an extension to the Member.

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Pharmaceutical Advertising Advisory Board (PAAB)

• Several supplementary guidelines to the PAAB code exist.  A recent example; “Guidance for Advertising/Promotional Systems (APS) Which Are Openly Visible in Healthcare Professional (HCP) – Patient Interaction Areas”
• Recently, PAAB has implemented the Health Canada document Interim Guidance on Fair Balance in Direct-to-Consumer Advertising of Vaccines
• You might also want to look at the PMCQ website for a list 100+ PAAB FAQs.
• No changes in the PAAB code.
• No changes in prescription DTCA guidelines
  

Canadian Association of Medical Publishers
It does not appear as though any new guidelines have been posted, since at the bottom of the CAMP advertising guidelines page, the last update appears to have been on May 11 2009.

MEDEC-Canada’s Medical Technology Companies
Revisions scheduled for March 2010.

Consumer Health Products Canada (previously NDMAC)
No changes, but expect some to come once their new website (along with new organizational name) gets launched within the next month or so.

Advertising Standards Canada (ASC)

• Any change in ASC guidelines would be from a result of changes with the Health Canada documents.  Since there have been no changes for the Health Canada documents, there have not been any changes for the ‘Consumer Drug Advertising Clearance’ documents of either the Prescription drugs or the Non-prescription / Natural health products (see the two boxes on the left of the ASC screen which allow you to choose the documents required based on the product type).

Health Canada’s documents regarding direct-to-consumer (DTC) advertising of prescription drugs

• Note that both PAAB and the ASC can provide an advisory opinion on DTC collaterals and campaigns.
• No changes for any of the following documents.

• The Distinction Between Advertising and Other Activities
• Advertising Campaigns of Branded and Un-branded Messages
• Product Package Representations in Branded Prescription Drug Reminder Ads Directed to Consumers

Health Canada’s documents regarding direct-to-consumer (DTC) advertising of non-prescription drugs

• ASC and MIJO can provide preclearance services with respect to consumer advertising of non-prescription drugs and natural health products.
• No changes for any of the following documents.

• Consumer Advertising Guidelines for Marketed Health Products (for non-prescription drugs, including natural health products)
• Therapeutic Comparative Advertising: Directive and Guidance Document
• Principles for Claims Relating to Comparison of Non-therapeutic Aspects of Non-prescription Drug Products

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Note that I am not a pharmaceutical regulatory expert.  I am providing these resources as a service to my blog’s readers.  If you have specific regulatory questions, please contact the appropriate organization.

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Stay in touch,
Natalie

Connect with me on the following networks:
FaceBook, Twitter, LinkedIn

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To ensure that you receive all new updates to this blog, insert your e-mail address in the box in the top-right corner. Your e-mail will remain private and will not be shared with any third parties.