PAAB Revisions: Real-World Evidence In Advertising -

This article provides an update to our series on the use of real-world data ("RWD") and real-world evidence ("RWE"). The Pharmaceutical Advertising Advisory Board (PAAB) has published revisions to the Code of Advertising Acceptance (the "Code") on the use of RWE in advertising directed to healthcare professionals ("HCPs"). The revised Code also includes guardrails related to use of subjective endpoints from open-label randomized controlled trials and data from clinical trials in other jurisdictions where the drug formulation differs from the Canadian formulation only in respect of inactive ingredients. PAAB has announced that the revised Code will take effect on February 1, 2024.

As we previously reported, PAAB submitted the revised Code and related draft guidance on use of RWE/RWD to Health Canada for consultation. The revisions to the Code bring it into alignment with the principles outlined in the draft guidance (which we discussed in a previous article) as well as PAAB's related guidance on use of the attention icon. The revised Code complements recent guidance from Health Canada, CADTH, and INESSS on use of RWE in submissions for regulatory approval and health technology assessments (which we discussed in a previous article).

The following is a summary of the revisions to the Code:

Section 3.1.1: Removes observational studies from the list of study types that are generally regarded as not being acceptable evidence in drug advertising.

Section 3.1.2: Permits use of RWE (including observational studies), subjective endpoints from unblinded randomized controlled trials, and clinical studies from other jurisdictions where the inactive ingredients differ from the Canadian formulation of the product. In each case, use of such evidence is subject to the guardrails on validity and presentation set out in PAAB's guidance documents on use of RWE and the attention icon (linked above).

Section 5.7: Clarifies that subjective endpoints from open-label trials remain unacceptable support for comparative claims but may be used for informational purposes in accordance with section 3.1.2.

Section 5.14: References guardrails for use of clinical studies from other jurisdictions where the inactive ingredients differ from the Canadian formulation of the product under section 3.1.2.

PAAB will not accept advertisements prepared under the revised Code until the implementation date of February 1, 2024. PAAB has stated that it is creating additional training documents to help prepare stakeholders for the application of the revised Code and related guidance documents. According to PAAB, the implementation of the revised Code will not impact the status of any presently approved advertising materials.

Our Life Sciences team has significant expertise advising the pharmaceutical industry on advertising compliance and other matters and is available to consult on the revised Code and related guidance documents.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.