Hello @tmcd As per the document Tips on Claims Relating to Patient Assistance Programs,: “Observational data on retention could be considered if the program has a valid and reliable mechanism to monitor when prescriptions are filled. Sufficient information about the program must be provided to enable PAAB to make this assessment. The APS claim/data from a manufacturer’s patient support programs should be non-comparative (as it relates to the manufacturer’s product), it should reflect past study findings (i.e. formatted in the past-tense), and it should be structured so as to limit the findings to the support program. Study parameters such as the time period pertaining to the claim/data could be relegated to a footnote. Note that retention data will be required to be updated every 6 months as changes in the market place can impact retention.”

Good Morning @donna The proposed change did not go forward. Although these were intended as the beginning of an incremental process of change, following consultation it became clear that the industry felt that the guidance did not go far enough. We are therefore awaiting preliminary output from the ongoing Health Canada and CADTH collaboration on decision-grade RWE. An expert stakeholder committee will work through that output to determine which elements are applicable to drug advertising. As a courtesy, the document Guidance on Observational Studies continues to inform on acceptable uses of observational studies in drug advertising.

Hey @Helen Section 6.6 was revised and repositioned to 1.5. Alternatively, this may have been a typo in the response letter. Please follow up with your reviewer if section 1.5 does not address the issue. With regards to archived versions of the Code, per PAAB Q&A 717, the PAAB website only contains the most recent version of the code so as to clearly promote current best practices.