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Pharmaceutical Advertising Advisory Board  |  October 2015
Providing a preclearance review that fosters trustworthy healthcare communications within a regulatory framework for the benefit of all stakeholders.
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Note From the Commissioner
As we move into the Fall, we have noticed that the volume of submissions has increased this year over last year and we appear to be on a record pace.  We thank the industry for excellent compliance overall.  We have had to make rulings on six stage two complaints which is a relatively large increase from two last year.  Most of those complaint files related to non-submitted materials, again indicating the value of the PAAB preclearance program.

The PAAB Board has commissioned two committees struck by the Commissioner: one to review the independent auditor’s report regarding the preclearance review mechanism, and the other a PAAB Code Committee.  The PAAB received a high rating from the auditor in the associated preclearance review mechanism report, though we recognize there is always room for improvement.  A meeting was therefore convened to review the auditor’s recommendations.  We value the comments received from the industry participants and we look forward to implementing some of the ideas generated at the meeting.

A second meeting was the initial meeting of the PAAB Code Committee. The Committee was created to review the recommendations submitted earlier in the year by the PAAB Code Gap Advisory Committee.  The group ratified most of the recommendations as needed and doable.  The hard work of bringing the generated ideas to life has just started and some time is needed for the PAAB to be able to bring those ideas forward into practice.

The PAAB staff remains the same, although we are without Vivien Fong who has just left on parental leave for a year.  I am optimistic that the staff will continue its fine turnaround record of 99.9% first reviews within ten days that we have accomplished this year.

We are looking forward to the two training workshops in November.  We have a large number of registrants so far, so get your name in soon if you want to be part of the learning curve.
 
Finally, we have launched our new communications plan and have started a revitalised use of Social Media to keep you informed of PAAB news and activities.  I thank the PAAB staff for the time and effort they have put in to make this transition.  Please remember you can always go to www.paab.ca and see everything you need to know about the PAAB.

As always, we welcome your thoughts on this issue of PAAB Views and on any content you would like to see covered in upcoming editions.

Sincerely,

Ray Chepesiuk
PAAB Commissioner
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PAAB Stats
January 1 through September 30, 2015
check Number of submissions: 5,396
check Time to first response: average of 6.93 days; 3 files beyond day 10
check Time to revision response: average 2.3 days
Updates
PAAB Refreshed Assets
In order to maximize the benefit of our communications and keep in more frequent touch with our important stakeholders, PAAB is pleased to advise that we have refreshed some of our existing assets. Click here for a short video to learn more about PAAB and our communications efforts.

We have prepared a content calendar for the remainder of 2015 that is based on requests for additional information we have received throughout the years. In addition to our planned features, we will also keep our eyes and ears open for any relevant news and updates that we can share with you from the wider environment.

To remain current and informed together, we encourage you to connect with us through our:
  • LinkedIn PAAB page: This is a new page where we will keep you updated on items specific to PAAB and the health advertising environment
  • LinkedIn PAAB group: We are maintaining the existing PAAB LinkedIn group page to continue to facilitate conversations with and between PAAB stakeholders about health advertising and communications; please feel free to post your topics of interest to engage with us and your colleagues
  • Twitter: We will be more active on Twitter moving forward, where we will share news and updates with you
  • Website: Our website will remain our main repository for all things PAAB, including our quarterly newsletter PAAB Views and our new monthly feature “Review tips and cases” where we will specifically address current submissions trends or key issues
  • Ask PAAB: We continue to encourage you to post any queries you may have to Ask PAAB, where we are always eager to answer your questions
We welcome your feedback along the way, so reach out to us with compliments or concerns; let us know what you think we’re doing well and where you think we could improve. We’re looking forward to staying connected!
 
Fair Balance Checklist
You’ve asked and we’ve listened. We’ve received requests for checklists to help guide selection of the standard fair balance content in drug advertising. This checklist is now available. Read more...

What We Can Learn From Kim Kardashian
Never would it have been predicted that Kim Kardashian would be covered in PAAB communications. However, she has incited advertising regulatory action by the FDA and that is PAAB worthy. PAAB has received more calls from media about this issue than any other topic in recent memory.

Kardashian was paid by Duchesnay to promote its brand of a morning sickness pill on Instagram to her large following. This was classified as direct-to-consumer advertising of a prescription drug by the FDA. There was no fair balance safety information presented in the ad. So Kardashian misrepreprented the product in the eyes of the FDA, and a letter was sent to Duchesnay advising them to stop doing so.

Some writers have said this is a new form of advertising and questioned why the authorities would regulate it. What Kardashian did is not new; celebrity endorsements have been around for a long time. A similar case study about FDA intervention was on Mickey Mantle promoting an arthritis drug on national television while being interviewed during a baseball game. Even in Canada, Scotty Bowman has been heard extolling the virtues of a prescription erectile dysfunction drug on public radio during an interview.  Both Mantle and Bowman were paid spokespersons.  So what’s the difference now? What was new was the use of Instagram and the rapid spread of the story. 

So if you are paying celebrity endorsers of your product, you should ensure they are aware that federal advertising regulations apply to product messages.  A good standard operating practice is to require vetting of messages by the company’s advertising compliance representatives before they are delivered to the public, just as you do with the rest of the advertising you create.  The PAAB is there to provide guidance on direct-to-consumer activities.  Contact us.  We will help you get to “yes.”
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Review Tips and Cases: Key Steps in the PAAB Approval Process
This visual interactive tool describes the various components of the PAAB approval process. Guidance is provided to help you navigate each step of the process. Read more…

PAAB is here to help you with the submissions process, and we have heard your requests for case examples. In response, we have begun adding review tips and cases to the PAAB website. Every month, we’ll add at least one new entry formulated specifically to address current submission trends or key issues. If you have any suggestions for future posts, please contact Deputy Commissioner Patrick Massad at patrickm@paab.ca.  
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Training & Events
Board Meeting Update
PAAB held a General Meeting of the Board of Directors on September 25, 2015. Highlights of the meeting are as follows.

The Board was updated by Glenn Golaz on the features, benefits, and advantages of the phase two implementation of the e-files system.  Several features will benefit clients by helping them track their own files.  Patrick Massad updated the Board on a future enhancement that arose from the Code Gap Advisory Committee.  We intend to allow clients to tag files with comments about the process. The reviewers will have similar capability.  This is a more advanced method of the random customer experience surveys that PAAB used to employ.  We are also looking at recording client-reviewer phone calls.  This will aid in future audits to assess the quality of the PAAB service.

The governance review is just about completed and the agreed-upon changes have been implemented.  Next the Board will tackle the large issue of Board structure.

Commissioner Chepesiuk reported back from the Review System Audit Committee meeting.  The Board indicated support in principle for a client training certification program. There is still interest as well in finding a way to gamify the Code training.

PAAB National Workshops
The agenda is ready and the dates are set for PAAB's only full-day workshops of 2015 (Nov 24th in Montreal and Nov 26th in Toronto). The 2015 PAAB training session lays out a clear methodology and shares proven tactics to help you understand the parameters of the PAAB Code, and how it applies to new channels and models of engagement.

You can see the full brochure which drills down into each session here: www.paabtraining.com 
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The PAAB Code
To see the current edition of the PAAB Code, visit our website.

 

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Our Mission
Mission: To provide a preclearance review that fosters trustworthy healthcare communications within the regulatory framework for the benefit of all stakeholders
Vision: Trusted healthcare product communication that promotes optimal health
Values: Integrity, competency, credibility, independence, excellence, transparency
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