67
If a product has a universally-accepted trait (such as no dose adjustment, no specific drug interaction), but this is not stated specifically in the TMA, can this claim be stated?
At times, some things are not specifically stated in the TMA or the TMA is not updated for a period of time. If a trait is universally-accepted, should it not be permitted to make this claim?
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View Answer [+]
The PAAB principle is: Generally, you cannot support a claim by omission of fact i.e. the absence of mention of a 'trait' in the TMA (Terms of Market Authorization) does not mean that it does not occur. It only indicates that it was not addressed and we do not know its outcome. For example, if no death were reported in the TMA, it is not sufficient to support a claim that the drug does not cause death unless there is a specific mention that "No death were reported". In summary, if a trait was truly "universally-accepted", it should have no problem getting into the TMA.
66
Does the exemption section 6.6d apply to new formats as well? As an example, "Company X is pleased to announce the availablity of a new format y for Product Z. For more information please contact...."
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View Answer [+]
Yes, as long as it is restricted to an "availability" message without further embellishment or additional message.
65
Is it necessary to include "Product Monograph available on request" on a direct mail or leave-behind that advises doctors of a drug now being covered on provincial formulary for a specific indication? No claims other than "Brand X now covered on Formulary y for z" (will have the exact wording from the provincial formulary). Understand that fair balance copy needs to be included and this will be submitted to PAAB.
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View Answer [+]
With the understanding that the fair balance copy already appears on the piece (and the piece submitted to PAAB for review), it would not be necessary to include the statement. Please note that prescribing information (PI) would also be required to accompany this piece as per PAAB Code s7.2 & 7.3.
64
Does exhibit booth panel text generated by head offices outside of Canada require PAAB approval for International conferences and symposia held in Canada?
Does an entry in an Exhibit Guide for an International conference or symposium generated by head offices outside of Canada summarizing a recent peer reviewed published clinical trial require PAAB approval?
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View Answer [+]
Health Canada has a policy regarding materials presented at International Conferences and can be found in the document "The Distinction Between Advertising and Other Activities" at http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/actv_promo_vs_info_e.html#International. To your question, based on the policy, the materials emanating from the parent company would not require PAAB review provided that they are only used within the confines of the conference and are prominently identified as not being authorized for sale in Canada.
63
When Pharma company sites post their PIs, or Rx drug ads on web sites link back to their PIs - does the access to the PI have to be password protected?
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View Answer [+]
Before answering this question, it is important to understand the differences between a PI (Prescribing Information) and PM (Product Monograph). The PM is the Health Canda approved document, it is considered non-promotional and can be made available on a company's website in a non-promotional manner. The PI is an abbreviated version of the PM. The PI is used to accompany advertising and must comply with the PAAB Code section 7.3. To address your question, the PI along the Rx drug ad should appear in a restricted site while the PM (not linked to any promotional activity) can appear in its entirety on an unrestricted site.
62
Is PAAB concerned if we are correcting typos, punctuation and spelling from a Product Monograph as it enters into a formatted monograph or a PI? Some monographs contains such errors yet pass through Health Canada approval. Does PAAB or Health Canada have a concern if these errors are corrected as the product enters promotion?
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View Answer [+]
As per the PAAB Code section 7.3, the sponsors are responsible for the content of the prescribing information (PI) while the PAAB will review the PI for format requirements i.e. PAAB will not be reviewing the PI text copy word-for-word. So PAAB would not have concerns about correcting typos, punctuations and spelling. However, you may want to verify with the company's Medical/ Regulatory Department that the intended message has not changed and that federal regulatory requirements are respected.
61
If an APS makes a usage claim (number of prescriptions or patient-years, for example) for an agent and shows the product logo, but provides no therapeutic claims for the product, does the indication have to be included? Other than an acceptable reference for the usage claim, is there any other balance copy necessary?
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View Answer [+]
Although there are no therapeutic claims for the product per se, the usage claim based on marketshare data is considered a claim of merit and viewed as promotional. Therefore, for clarity and completeness as per PAAB Code 2.1 & 2.1.2, the APS should state what the product is indicated for. As for the fair balance requirement, we would need to see the APS in proper context (with visual and text) in order to determine what balance copy is necessary. Keep in mind that fair balance requirement is also based on the product monograph.
60
Can you please provide some clarity on the criteria regarding co-sponsorship with a physician/patient/nurse/pharmacist group(s) that would allow for PAAB exemption? That is, what criteria make one group more or less acceptable from a PAAB perspective?
To clarify, if a pharma company wishes to sponsor the development of and work with an organization to supply patients with information on a particular disease state/condition in an unbranded piece how does PAAB judge whether this would/would not be exempt from pre-clearance.
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View Answer [+]
The criteria for PAAB review exemption are clearly stated in section 6.6 of the PAAB Code. For this case, the materials would need to be independently controlled and prepared without company involvement. If the materials are intended to be used by healthcare professionals for patient counseling and distributed by the company, it would be subject to the PAAB review under section 6.4 (as a service vehicle). Please note that while it may be exempt from the PAAB review, the material may still be considered 'advertising' under the Food and Drugs Act.
59
Is Brogan data an acceptable data source to show how long your patients are statying on therapy?
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View Answer [+]
Without getting into specific data from individual companies, the PAAB Guidelines for the Review of Market Share Claims (see www.paab.ca) clearly state that market share claims must accurately reflect the findings of the source and the appropriate wording must be used. So, if the source shows "retention" data that is collected from prescription refills, it would be considered. However, the data presentation must not imply any clinical significance or benefits and be reflective of current medical practice (PAAB Code s3.2).
58
For an advertisement stating that sample packages for Product X are available from company Y's pharmaceutical sales representatives, would PAAB preclearance review be required?
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View Answer [+]
If it is simply a sample availability message (with no additional message or embellishment), it would not require PAAB review, however, the sample holder / kit may be subject to the PAAB review depending on the content on the box. Please note that a simple message of product availability (Product X available from Company Y) would meet the current PAAB Code exemption (s6.6d).
