Background

The Pharmaceutical Advertising Advisory Board (PAAB) supports truthful and balanced health product advertising that is compliant with federal legislative regulation primarily through its preclearance mechanism.  Health product advertising directed to health professionals is reviewed against the standards in the PAAB Code of Advertising Acceptance (hereinafter referred to as the Code).

The Code is undergoing revision primarily to reflect modernization of how PAAB reviews Real-World Evidence (RWE).  The draft RWE guidance document was created by an expert industry committee (a subsection of which had also participated in CADTH’s RWE initiative).  The guidance outlines a factual, transparent, balanced, and evidence-based approach that is tailored specifically for inclusion of RWE in health professional targeted advertising.  The guidance document had undergone several thorough and broad rounds of industry consultation.  The final draft of the guidance also underwent health professional consultation in the form of a survey.  This posted version of the Code and the corresponding guidance documents are presently undergoing Health Canada consultation.   

Summary of the Current vs. Proposed Approach

The existing Code standards and guidelines allow for inclusion of RWE findings in advertising only when replicated in high-quality randomized controlled trials. The proposed changes would significantly expand the range of RWE findings that are permissible in advertising. Acceptability would be contingent upon meeting specified standards for evidence quality and relevance. Furthermore, the presentation in the advertisement would need to conform to particular formatting standards, ensuring clear reflection and conveyance of the study type and its associated limitations.

Regarding open-label randomized controlled trials, the current Code allows only objective endpoints in drug advertising. The proposed changes would permit subjective endpoints as well, given that the presentation aligns with specified formatting standards. Presently, for clinical trials from other jurisdictions to be included in advertising, the master formulation of all evaluated health product interventions must match the Canadian master formulation. The proposed changes would relax this stipulation, permitting differences in inactive ingredients from the Canadian formulation, provided specific disclosure and presentation requirements are met.

These additional proposed changes echo the novel approach introduced for RWE. However, to ensure clarity, we've also produced a separate guidance document exclusively detailing these additional modifications.

Text Comparison of Current Code vs. Proposed Code

All proposed changes to the Code are tabulated below:

• The left column displays the existing Code section.
• The right column illustrates the corresponding proposed Code section.
• To highlight specific modifications:
  • Green text indicates additions.
  • Red strikethrough indicates deletions.

Target Implementation Timeline

We hope to implement these modifications by January 2024. The fact that the proposed changes won't impact the regulatory status of any presently approved materials enables for a short transition period.

Contact, Questions, and/or Feedback

We welcome your input on these proposed changes. Should you have questions, comments, or suggestions for future considerations, please engage with us on the PAAB Forum or reach out to patrickm@paab.ca.

Current	Proposed Future
3.1.1 Clinical or therapeutic claims must be based on published, peer-reviewed, controlled, and well-designed studies with clinical and statistical significance clearly indicated. Review articles, pooled data, meta-analysis, post-hoc analysis, and observational studies are generally regarded as not being evidence to support claims in drug advertising. Data included in the TMA may be acceptable. Additionally, high quality meta-analysis and observational studies may be acceptable. Non-clinical claims must be well supported by relevant evidence.	3.1.1 Clinical or therapeutic claims must be based on published, peer-reviewed, controlled, and well-designed studies with clinical and statistical significance clearly indicated. Review articles, pooled data, meta-analysis, and post-hoc analysis, and observational studies are generally regarded as not being acceptable evidence to support claims in drug advertising. Data included in the TMA may be acceptable. Additionally, high quality meta-analysis and observational studies may be acceptable. Non-clinical claims must be well supported by relevant evidence.   3.1.2. Clinical and therapeutic APS presentations based on the following types of data are required to meet tailored standards outlined in the listed guidance documents: Real-World Evidence (including, but not limited to, observational studies). See the RWE Guidance Document for evidentiary and presentation format considerations. Subjective endpoints from unblinded RCTs. See the Attention Icon Guidance Document for presentation format considerations.   Clinical studies from other jurisdictions where the inactive ingredients differ from the corresponding Canadian version of that product. The therapeutic use evaluated in the study must align with the use approved in Canada for that product. All relevant provisions of the code apply to inclusion of the study within advertising targeted to Canadian health professionals.  See the Attention Icon Guidance Document for presentation format considerations.
5.7 Comparative claims of efficacy and safety generally require support of evidence from head-to-head, well-designed, adequately controlled, blinded, randomized clinical studies. Open-label studies are generally not considered to be a high level of evidence and are not acceptable if subjective end-points are included in the study. Comparative claims should be consistent with current medical opinion and practice. Canadian guidelines are to be adhered to. In the event that they are not available, see the following document on what constitutes current medical opinion. Guidance on current medical opinion.	5.7 Comparative claims of efficacy and safety generally require support of evidence from head-to-head, well-designed, adequately controlled, blinded, randomized clinical studies. Open-label studies are generally not considered to be a high level of evidence and are not acceptable support for marketing benefit claims relating to subjective endpoints. if subjective end-points are included in the study. For standards pertaining to informational presentation of subjective endpoints in open-label trials, see s3.1.2. Comparative claims should be consistent with current medical opinion and practice. Canadian guidelines are to be adhered to. In the event that they are not available, see the following document on what constitutes current medical opinion. Guidance on current medical opinion.
5.14 Formulation. Studies using non-Canadian products are not accepted unless the advertised Canadian product is identical (for example identical master formula) to the corresponding non-Canadian product used in the original studies. A letter from the sponsor’s Medical/Regulatory Department would be required.	5.14 Formulation. Marketing benefit claims based on studies using non-Canadian products are not accepted unless the advertised Canadian product is identical (for example identical master formula) to the corresponding non-Canadian product used in the original studies. A letter from the sponsor’s Medical/Regulatory Department would be required. Where the inactive ingredients differ see s3.1.2.

S1.8 Definitions (unchanged)

Marketing Benefit Claim:

A statement that is designed to promote the sale of a health product. It often highlights a specific product attribute i.e., “longer lasting” or “tastes great”.

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 (i.e., text) or implicit (i.e., images), comparative or non-comparative. It can relate to pharmacological or non-pharmacological properties of the product.

Not all statements about a product are “marketing claims of benefit”. Common examples of product messaging which are not considered marketing benefit claims include product reconstitution instructions, monitoring instructions, dosing modifications for special populations and storage instructions when these are presented as instructions/burdens rather than features/ benefits (i.e., presented to instruct rather than alter/form the audience’s opinion of the medication in a positive way). How a statement is framed can sometimes affect whether it is a marketing benefit claim. For example, the copy “Arbace: Convenience of a single daily dose” is a marketing benefit claim, while “Patients should be instructed to take a single dose daily at the same time each day” is not.