Hi Danika - The RWE Guidance document does mention that Class B opioids and NOC/c products are not in scope, given APS for those products are limited to content from the TMA. However, other controlled drugs may be permitted to utilize RWE. Also see Q&A 4213

To add another example, what about non-clinical claims about dosing like 'once-monthly'?

Hello @support If we are to assume that this is in an HCP gated space, we would advise that claims should not directly/indirectly highlight things like the shortage of competitor(s). Instead, the message may focus on reminding the audience about the sponsor’s product and availability in the market. You correctly identified that it would not be exempt. The piece would be subject to the Code and would require lowest level fair balance if restricted to a product availability message.

Hey @dlew Coverage claims may be considered in HCP APS. Patient information should not contain promotional claims but formulary information may be considered. Please see our patient information guidance. HCP claims about “cost” should be factual and complete. A claim of “at zero additional cost for most patients” would be a hanging comparison and would need to clearly state versus what and be supportable across all public and private payers. Remember that formulary bodies have requested that messaging around coverage be limited to statements of coverage and not promotional messaging around “savings”. Additionally, messaging around cost should be clear about what costs (e.g. drug acquisition costs, mark-up, dispensing fee, etc.). Private coverage claims can be supported by independent third party data from an established company who assess’ market access.

Thank you!

Hey @Maryssa Any ad which appears in the consumer space (even when limited through targeting based on interests or profession), are subject to the direct-to-consumer advertising regulations. Link to therapeutic use through study design, name, description, fair balance, or any other form, would not be acceptable since it would contravene Section C.01.044 of the Food and Drugs Act and Regulations which does not permit advertising of prescription medications to the general public beyond name, price and quantity.

Hello @adelaidebaker Per Health Canada’s Terms and Conditions for Class B opioid products, advertising is restricted to messaging verbatim from the Health Canada approved Terms of Market Authorization. While “market research” and “claims” are broad and unclear, it is unlikely that market research can be used in advertising. If you have a specific case in mind, we invite you to submit for an opinion where additional context can be provided.

@Jennifer-Carroll Thank you!

Hello @Jennifer-Thomson It sounds like this would fall under a PILOT: Administrative Guideline for the Review of Pre-NOC Advertising Submissions. We’d get the file to “no further comments” pending review of the layout (video) post NOC. Please reach out to admin to discuss the specifics so that we can ensure we’re understanding the request and facilitating the best possible pathway to approval.

Hi @Jennifer-Carroll Thank you!

Hello @msargeant Apologies for not seeing this question sooner. Per 3.1.1, post-hoc analysis are generally not considered acceptable evidence at this time. The circumstance in which post-hoc analyses would be considered acceptable is outlined in the statement that follows that copy which states “Data included in the TMA may be acceptable”. HTH.

Thank you @Jennifer-Carroll!

Thank you @Jennifer-Carroll. This is very helpful!