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Past Meetings

February 21, 2012
PAAB Wants You: Have Your Say in the PAAB Code Change

Speaker

Patrick Massad, Chief Review Officer, the Pharmaceutical Advertising Advisory Board (PAAB)

The PAAB Wants Me? What Do They Want With Me?
Relax…They just want to talk!

Ask industry people what they think of the PAAB, and you’ll likely hear a litany of anecdotes about how they’ve locked horns with one reviewer or another while attempting to get a key piece of advertising accepted. Some people tend to have a cynically adversarial view of the PAAB, while at the same time exercising exquisite civility in their dealings with this regulatory body for fear they’ll compound their issues. It brings to mind the relationship between a police officer and the motorist he or she is ticketing. But the PAAB wants to change that erroneous perception. They want YOU! Or more specifically, they want your input over proposed changes to the PAAB code. Essentially, they want your perspective.

Tilting at Windmills
Or…when is the enemy not the enemy?

To answer the preceding question, in short: When the “enemy” is there to prevent you and your company from heading down a path fraught with legal wranglings, retractions/reprints, and potentially costly lawsuits. Underscoring this point is the fact that the PAAB issued eight monitoring notices in the last quarter of 2010 involving (alleged) paid editorial articles by pharma companies. All were judged to be advertising, and contained references to such no-nos as off-label content, unapproved drugs, comparisons based on unsatisfactory evidence, and/or no balance in terms of risk information.

The February 2012 PMCQ dinner meeting was guest-moderated by the esteemed Joseph Atallah, Director of Scientific Operations at Novartis, and the invited speaker was the affable and straight-talking Patrick Massad. As Chief Review Officer at the PAAB, he has, in one way or another, been involved in the final content of your agencies’ advertising business. When questioned about the general perception of the PAAB as the advertising “police”, he offered this typically low-key response: “I don’t see it that way. We’re here to keep our clients out of trouble; hence the preclearance mechanism. Sometimes that means saying ‘no’, but we do what we can to guide clients to a ‘yes’ with suggestions. I prefer to think of PAAB as having an advisory role, rather than a police role.” Although the PAAB acts in an advisory capacity, the industry agencies are essentially self-regulating. And, according to Patrick, “Self-regulation works best when people are engaged and participating in it.” This is where you come in: to advise the advisors. But more on that later.

If you’re in a bad situation, don’t worry—it’ll change. If you’re in a good situation, don’t worry—it’ll change
All kidding aside, there is seldom progress without change

Some changes are in the works at the PAAB in terms of clarifying parts of the code. The above-mentioned monitoring letters prompted numerous requests for in-house workshops so that advertisers could better understand the rules. As a result of these educational sessions, it was found that people wanted a tool that would complement the existing Health Canada “Distinction Between Advertising and Other Activities” document, as well as Section 6.6 of the PAAB code. The PAAB has been working on this “decision tree” tool and welcomes your comments and suggestions on how it should be developed. If you would like to add your voice, you may contact Patrick at patrickm@paab.ca

When Is Advertising Not Advertising?
Rarely. If it walks like an ad, and talks like an ad…You’re trying to market your product—of course it’s an ad!

And regardless of its educational value, it will be subject to the PAAB regulations. In fact, even if a material or activity wouldn’t otherwise be deemed as advertising in terms of content, it can cross the divide into the advertising realm depending on whether it meets certain distribution and availability criteria. All roads seem to lead to PAAB, and as such, it is in the advertisers’ best interest to participate and share their input and insights to ease their understanding and navigation of that road network.

A Collaborative Consultation
All for one, and one for all

The four major areas of proposed code revisions are: Product Information and Fair Balance; Evidence for Claims; Online Marketing Activities to Health Care Professionals and Direct-to-Consumer; and Nonprescription (OTC) and Natural Health Product Advertising Requirements.

The PAAB would like to hear what you have to say about the above sections, as well as other sections that you feel should be revisited. PAAB has jump-started the process by having four expert committees provide revision recommendations. These recommendations are currently being evaluated by over 1,000 PAAB stakeholders by survey.

Now this is where you come in: To make this a truly cooperative endeavor and to come to some sort of consensus, the survey will only allow for one person within each organization to respond. However, the PAAB has done it this way to ensure interdepartmental collaboration for a single, unified response from each organization. Haven’t heard about this yet? Find out who is coordinating your company’s response. Having trouble tracking down the survey-keeper? Send Marla Weingarten an e-mail to see who your coordinator is: mweingarten@pangaea-consultants.com . The survey deadline is March 15th, so don’t delay in letting your voice be heard! Oh, and bear in mind that all results are anonymous to the PAAB’s staff; the key is to encourage honest input and foster renewed understanding, so speak your mind.

Based upon the survey results, the expert committee will decide what to propose for the draft code. It will then undergo review by the PAAB board and be endorsed by Health Canada, with final approval slated for August 24, 2012, as long as all goes according to plan.

Decluttering the Code
KISS (Keep it Simple and Straightforward)

Rather than ease changes into the code sequentially, it was decided for simplicity’s sake that the goal would be to have a single set of changes vetted by a single consultation. While space doesn’t allow for an in-depth look at all the proposed changes, and while all are important in their own right, a few are bound to cause a bit of industry chatter. Among them:

• Replacement of the Product Information (PI) documents by an electronic link (directing the reader to the Health Canada Drug Product Database)
• A modified fair balance copy format based on fixed levels of fair balance which correspond to specific messaging criteria (easier for the healthcare professional to use; risk copy would stand out more due to less clutter), the options of which are as follows:
  • Standard fair balance
  • Brief fair balance
  • General statement of risk
  • None
• Replacement of p-values by confidence intervals (CIs)

This last point already generated some post-meeting discussion. While from a regulatory standpoint the p-value may not be precise enough, some attendees felt that the physicians’ main concern is simply to see that significance has been reached, while others were adamant that it is essential to show the exact distance separating the data points as measured by the CI. Still others questioned if some older physicians would even fully grasp the CI’s implication. When asked about this post-meeting debate, Patrick stated, “This is an example of why stakeholder consultation is so important. The committee will have the opportunity to put some thought into concerns like these.”

Find Out More
Make your opinion count!

All relevant documents that deal with the proposed code changes can be found on the PAAB’s Website at https://code.paab.ca/ or go onto www.paab.ca and see “PAAB Code Review 2012” in the navigation bar item “PAAB Code + Advisories”. There are upcoming Webinars that deal with various aspects of the changes, including the PI (March 6, 2012; 11:00-12:00); Evidence: (March 7, 2012; 11:00-12:00); and Online Activities (March 8, 2012; 11:00-12:00). Have your questions ready!

Recap

 

• PAAB is offering guidance, as requested by the industry, on section 6.6 of the code, as well as other areas a consensus considers important
• You have a chance to provide input in terms of format, clarity, and scope of the recommendations
• PAAB is here to help you; never hesitate to call with questions
• Participation in the preclearance mechanism continues to grow
• There has been continued demand for PAAB educational sessions, indicating a need for clarity

 

Conclusion

Patrick reiterated during the question period and again upon interview that he sees the increased demand for code education as a great sign that people recognize the importance of understanding the rules of advertising acceptance. So why not just change the rules without consultation? Wouldn’t it make the PAAB’s job easier? Not according to Patrick: “The main point is that people should get involved. Even in terms of this meeting, for some in the audience, the presentation was a primer for the reading they are about to embark on.” And how else can the PAAB help the industry? In what other ways can the industry help the PAAB? Just pick up the phone: “Dialogue is typically a good thing,” Patrick submitted. Thinking perhaps of the “advertising police” perception he had hopefully successfully dispelled among attendees, he added, “I hope people feel they can call me or the Commissioner to express their concerns.” You heard the man. Now he wants to hear from you.

Tara Mitrovka
Medical Writer/Editor
Editcetera Writing Services

Email: editcetera@gmail.com
Cell: 514-886-6565
LinkedIn Profile

 

 

Luckily, if you missed out, we have 'PAAB Wants You: Have Your Say in the PAAB Code Change' slides right here.