Note From the Commissioner

In this issue of PAAB Views, you’ll find a new guidance on Branded Patient Information APS that was drafted in response to previous client feedback, as well as additional clarifications and updates. The topic of this month’s Review Tips and Cases is “Marketing Benefit Claims ̶ What Are They and What Level of Support Do They Require?” We’ve also included a reminder of the PAAB escalation process, and a link to additional information regarding the upcoming PAAB National Workshops.

We’re pleased to share the results of the PAAB Preclearance Review Mechanism Audit, and encourage you to reach out to us with ongoing compliments or concerns. Let us know what you think we’re doing well and where you think we could improve. Specific examples always help us better take action, so thank you in advance for sharing them when you can.

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

PAAB Stats

January 1 through June 30, 2015

Number of submissions: 3,814

Time to first response: average of 6.75 days; one file beyond day 10

Time to revision response: average 2.2 days

Updates

PAAB Guidance on Branded Patient Information APS
PAAB has performed several client surveys in the recent past in order to obtain client input regarding a wide range of topics including PAAB Code gaps, PAAB communication initiatives, and PAAB customer service. A consistent ask from the industry has been for additional guidance on manufacturer-generated, branded, patient information for prescription drug products. Our clients spoke and PAAB listened. Click here for the new detailed guidance document.

What constitutes current medical opinion and practice?
PAAB Code s3.2 requires that claims be consistent with current Canadian medical opinion/practice. PAAB considers a claim’s alignment with authoritative Canadian consensus guidelines as evidence of consistency with current Canadian medical opinion/practice. This is based on the fact that consensus guidelines are widely recognized to be useful aids in clinical decision-making. Read more... 
 
PAAB Preclearance Review Mechanism Audit Report
Recognizing that consistency in reviews has been expressed by some as a concern, PAAB took the initiative to implement an independent audit of the preclearance review system commissioned by the PAAB Board of Directors. The audit was completed by Integrated Pharma Services Inc., under the direction of Richard Khambatta, General Manager. The audit assessed the overall operational performance within the PAAB preclearance review system and the level of consistency within the system. The full audit report is available upon request. Summary slides of the results can be accessed here...
 
Clarification of the PAAB Escalation Process
The PAAB is committed to providing written correspondences which clearly outline code infractions and, where possible, provide suggestions on how to move forward toward approval. However, additional dialogue is sometimes helpful to clear up areas of contention or confusion. Should the need arise, a phone call can be scheduled with a reviewer in order to obtain clarification on a review comment. Contact our administrative staff to set up a call from a reviewer. 

There is also a formal escalation process for important disagreements between the client and the reviewer. Clients may escalate the review decisions to the Deputy Commissioner upon receiving a PAAB letter about the same issue which was discussed on the phone with the reviewer. This process is outlined in the PAAB Code (s8.6.ii) and in the “Guidance Document for the Submission Process” on the PAAB website. Representatives from the manufacturer will be required to participate on an escalation call. If you wish to escalate a review comment, please contact PAAB administrators with the eFile # and the issue to be discussed.

Please note that the formal process above relates to escalations for disagreements relating to particular comments within a submission under review. The PAAB is always open to discussing concerns and suggestions about broader issues such as customer service, efficiency, and consistency. As a continually improving organization, we welcome your input. Please contact Deputy Commissioner Patrick Massad or Commissioner Ray Chepesiuk.  

PAAB Complaint Report

During the period of April 1, 2015 to June 30, 2015, the PAAB Commissioner processed two Stage 2 complaints. 

In addition, PAAB has continued to regularly monitor journals and the Internet, and receive direct-mail/detail aid materials collected by health professionals as part of its monitoring program. When Code violations are discovered, PAAB sends a letter to the advertiser seeking their cooperation to meet the requirements of the Code. When appropriate, PAAB will notify the advertiser’s trade association and/or Health Canada for their assessment of additional penalties.  The PAAB sent zero monitoring notices during this period.

Stage Two Decisions

File #C15-07
ADVERTISER:  Medical Futures Inc. (MFI)
COMPLAINANT:  BioSyent
SUBJECT: 3 promotional detail aids distributed to pharmacists
PRECLEARANCE: No
ALLEGATIONS: Alleged misleading claims regarding “optimal iron” and alleged potentially misleading comparative claims vs Feramax.
DECISION: Ruled in favour of BioSyent allegations.  MFI to cease and desist the alleged claims and recall material if distributed to health professionals.
OUTCOME: Both parties agreed with the decision.

File #C15-04
ADVERTISER:  Odan
COMPLAINANT:  BioSyent
SUBJECT:  Promotional systems for Odan Polysaccharide Iron Complex
PRECLEARANCE: No
ALLEGATIONS: In APS distributed to health professionals, Odan claimed that its Natural Health Product (NHP) “is a generic iron complex duly approved by Health Canada containing 150 mg of iron and is therefore, from a therapeutic perspective, comparable to BioSyent’s FeraMax 150 mg product.” PAAB received clarification from Health Canada about the claim of “generic equivalence” which stated “Although Health Canada does have guidelines about bioequivalence for products regulated under the Food and Drug Regulations, these do not apply to NHPs. There are no patents for NHPs and therefore no generics and no bioequivalence policy. However, comparative claims (eg, equivalent efficacy, same duration of action, etc.) are permissible and should meet the requirements set out in the Therapeutic Comparative Advertising Directive and Guidance Document.”
DECISION:  Agree with BioSyent that Odan’s claims for generic equivalence are false and misleading because there are no generic NHPs and Odan has provided no scientific evidence for bioequivalence to Feramax 150 mg.
OUTCOME: Both parties agreed with the decision.

Review Tips & Cases

Marketing Benefit Claims  ̶  What Are They and What Level of Support Do They Require? 

A marketing benefit claim is a promotional statement designed to inform about the product’s availability and benefits so as to form/alter the audience’s opinion of the medication. It can be explicit (ie, text) or implicit (ie, images), comparative or non-comparative. It can relate to pharmacological or non-pharmacological properties of the product. Consult our Quick Tips document for some examples of different types of claims, and what type of evidence/sources would be considered acceptable in advertising.

If you have any suggestions for future Review Tips and Cases, please contact Deputy Commissioner Patrick Massad at patrickm@paab.ca.  

Training & Events

Board Meeting Update
PAAB held a General Meeting of the Board of Directors on June 25, 2015. Highlights of the meeting include:

1. Governance Restructure – The Board agreed that the Chair will meet with Directors individually over the phone to discuss the proposal of downsizing the Board, changing from the membership representation model to a skills-based model, and implementation of staggered Director terms.
2. Code Committee – Commissioner Chepesiuk reported that he was nearing completion of setting up the Code Committee and the first tasks would be to find a date for the first meeting and to elect a Chair of the committee.
3. Preclearance Review Mechanism Audit Report – The group was in agreement that PAAB would seek input from an advisory committee on the recommendations of the PAAB Audit of the Review Mechanism. The report will be non-binding on the Commissioner. The group agreed that the full audit report should be available on request.
4. Communications – Salient Communications presented an update on key communication activities/initiatives that have taken place since the last Board meeting in April.  The group agreed on an approach to communicate the findings of the PAAB Review Mechanism Audit regarding consistency of reviews.
5. Strategic Plan – Commissioner Chepesiuk reported that the PAAB has completed most of the actions required by the strategic plan and the Board should consider the date of the next plan. It was agreed Fall 2016 would be good timing.

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