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The left side of the code lists the principles and standards. The right side gives examples or interpretation as a guidance that does not fit all scenarios. Paraphrasing is subject to interpretation as well. You must meet the requirement in the left side.
If a pharmaceutical company was to sponsor a Canadian Association's medical educational piece, would this require PAAB approval?
A pharmaceutical company can sponsor a Canadian association's medical educational piece. Determining whether the piece is exempt from PAAB preclearance involves considerations beyond simply the existence of sponsorship. Let's go over some common scenarios and discuss the answer for each.
Scenario #1: An existing piece which had already been independently controlled and prepared by the Canadian association with industry involvement limited to purchase and sponsorship of distribution. Exempt from PAAB pre-clearance.
Note that content which is exempt from PAAB preclearance is not necessarily exempt from the advertising provisions of the Food and Drugs Act/Regulations and the principles of the PAAB code. For example, distribution in a promotional context (e.g. by drug representative) may render the message promotional.
Scenario #2: A pharmaceutical company has provided an unrestricted grant to a Canadian association for the creation of a medical education piece. Exempt from PAAB pre-clearance.
In this scenario, influence from the pharmaceutical company is limited to selection of the broad therapeutic area (i.e. broad area of interest rather than specific topic). The pharmaceutical company has no awareness of the content until the piece is complete at which time the company may simply determine whether it will use the piece. Again, note that content which is exempt from PAAB preclearance is not necessarily exempt from the advertising provisions of the Food and Drugs Act/Regulations and the principles of the PAAB code. For example, distribution in a promotional context (e.g. by drug representative) may render the message promotional.
Scenario #3: A pharmaceutical company exerts influence over the process or content generated by the Canadian association. Not exempt from pre-clearance if it is a healthcare professional directed piece discussing pharmacotherapy.
The piece would require PAAB pre-clearance if the pharmaceutical company or its agent has influence over the content or process beyond selection of the broad therapeutic area (e.g. providing specific directions regarding area of focus, input on author selection, input on scope of research, or editing privileges). In such cases, the piece would be reviewed as a product branded APS if the content emphasizes or favours the sponsor's brand. If the content does not emphasize or favour the sponsor's brand, it would be reviewed as an editorial APS.
No.
I intend to send out a PAAB-approved promotional piece to physicians in a direct mail campaign for an OTC product. I was also considering including a product coupon. The coupon will display the brand name, package shot and discount amount. There will be no claims. Should the coupon be submitted to PAAB, given that it will be distributed in the same envelope as a promotional piece?
In this scenario, the coupon piece should be precleared if claims are visible on the package shot visual within the APS. Otherwise it is exempt from preclearance.
Either way, please inform us of the linkage to the PAAB approved piece. We would need to assess the appropriateness of the linkage. For example, the coupon piece should not accompany an editorial (unbranded APS) as this would inherently brand that piece.
This activity is not necessarily a PAAB issue. See the Rx&D code section 8 about representatives activities and distribution of materials. CME can contain off-label claims which a company cannot legally promote. So is the rep promoting those claims by directing a viewer to that CME? The PAAB code covers materials, and thus it depends on the content of what is being handed out.
Two schools of thought prevail here. One is the rep acting as courier. The second is if representatives are paid to sell product, why are they involved in a nonpromotional CME activity? They are creating a selling opportunity through the use of a specific CME event, thereby linking a promotional activity to a nonpromotional activity. Reps could promote the company CME service and not individual programs.
We believe the more ethical road that stands up to public scrutiny and possibly avoid regulatory jeapardy is the latter.
The physician should be directed to contact the medical department of the Canadian subsidiary (in cases where one exists). One of the main concerns is potential confusion regarding the status of Health Canada approval for a product or a use. For example, in cases where a product or use is approved in the US, the US manufacturer would send a US Brief Summary for that product in addition to the specific response. This could potentially confuse/mislead a Canadian physician into thinking that a product or use has been approved here in Canada.
In cases where there is no Canadian subsidiary (i.e. this medical service will need to be provided through the US), ensure that a US Brief Summary is not provided. This may require training of the medical department staff as it is counterintuitive.
Aside from this nuance, the regulations pertaining to US manufacturers responding to unsolicited requests from Canadian physicians are the same as those pertaining to Canadian manufacturers.
As per the Health Canada policy document The Distinction Between Advertising and Other Activities: "Information provided to an individual about a drug treatment(s) by a pharmaceutical manufacturer in response to a request for information that has not been solicited in any way (by the manufacturer of the drug) is not considered to be advertising for the sale of a drug".
The response should be limited to that which is required to answer the specific request. It is advisable for the medical department to document the details regarding the request (e.g. date, name of requester, nature of request, content provided, etc). Please call the PAAB if you have any further questions about this.
If your file status has been changed to "Revision Required" you should have received an email with the Reviewers comments attached. If you did not receive the email, please check you spam or speak to your IT department to ensure PAAB is on your white list. Please call the PAAB if you require further assistance regarding your electronic submission.
What is PAAB?
Incorporated in 1976, the Pharmaceutical Advertising Advisory Board (PAAB) is a not-for profit, self-financing organization funded entirely by the fees paid by advertisers for preclearance review (not for the acceptance). The highly trained PAAB staff runs the preclearance program to ensure that proposed advertising meets Code standards for the promotion of pharmaceutical products. The PAAB code can be found at the following URL: https://code.paab.ca/
The code was created (and is maintained on an ongoing basis) by the PAAB Board of Directors. The following organizations are members of the PAAB and have appointed official representatives to its Board:
The PAAB mission is to provide a preclearance review that fosters trustworthy healthcare communications within the regulatory framework.
The PAAB's primary role is to ensure that healthcare product communication for prescription, non-prescription, biological and natural health products is accurate, balanced and evidence-based, and reflects current and best practice. The PAAB also monitors trends in health product advertising and promotion and adjusts its code and practices as required to fulfill its mandate.
The scope of the PAAB includes promotional healthcare product communication for prescription, non-prescription, biological and natural health products to health care professionals in all media. PAAB also provides advisory comments on direct-to-consumer materials for prescription drugs. PAAB's Scope evolves with the regulatory framework.
Please visit our website at www.paab.ca for more information and don't hesitate to call us at (905) 509-2275 if you have any questions. Also find us on LinkedIn, join the PAAB group and participate in the discussion!
If we were to have a backorder situation for one of our products and we wanted to inform pharmacies of this fact by way of a letter or fax to help prevent a backorder, would this letter/fax need to be PAAB approved?
I was reviewing section 6.2 for clarification, and believe that it does not need submission to PAAB (I believe it's an institutional message), however I'm not entirely sure?
Actually, you would want to refer to PAAB code section 6.6.d. The intent of section 6.6(d) is to allow for the expedient communication of non-comparative, commercial messages. These include changes in availability, price and formulary coverage.
If the only message in the letter/fax is that the product is backordered, than the ad is exempt from PAAB review.
Clients often elect to also include messaging regarding alternative therapeutic options for consideration during the back order. This would be an example of something which would disqualify the ad from being exempt.
Please call the PAAB office if you have any questions. Also refer to Q&A # 155.
Yes. Review of this change would not be required. We ask that the updated APS be sent to review@paab.ca as an FYI. It is important that the PAAB has the current version of the APS on file. Please call Laurie or Sabrina if you have any questions regarding FYIs.
Jennifer Carroll
Senior Reviewer Communications
Pharmaceutical Advertising
