Hi there,
PAAB can provide approval to APS with links to PAAB acceptable pre-proof articles (see also Code section 3.1.2). However, it is the responsibility of the sponsor to ensure that there are no restrictions to the distribution of the pre-proof article prior to full publication (Code section 3.3).
This post was answered through our office earlier but we will post the answers here as well.
This one is tough to answer in a general forum since there are a lot of considerations. First and foremost, the indication is the limitations for the Terms of Market Authorization and therefore sets the context of messaging within advertising. Code section 2.10 applies regardless of perception that terminology has changed. Next, this is a great opportunity for PAAB to remind clients that we do accept endpoints and terminology not listed in the TMA. What we look for is “consistency with the TMA”.
Let’s look at a few examples of where it would not be acceptable.
If a more specific assessment would provide more value, we invite you to submit for an opinion. You may also reach out to admin to set up a short billable consult meeting that would allow discussion of the specific example (more details to come about this service)
Per Health Canada guidance, PSPs are not a type of additional Risk Minimization Measure/Tool, therefore, there should be no mention of the PSP within the RMT. Participation in the PSP should not be seen as a part of conditions for receiving the drug. Given this, the enrollment form question would be moot. Please, let us know if any new questions come up given the response.
Hey @dmauri, we haven't forgot about this question. It promoted an internal discussion to find the best solution moving forward. We'll look to get a full response posted some time next week. Thanks.
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.
It’s Friday @Agency @Manufacturer and PAAB wants to send you into the weekend with some exciting news: The NEW Creative Imagery in Advertising Advisory is NOW live!
After months of insightful and collaborative discussions, we’re excited to finally announce PAAB’s new advisory on the use of creative imagery in pharmaceutical advertising. Industry has asked for clarity, and we hope this document provides that clarity you’ve been waiting for, or at the very least, provides a stronger framework to evaluate creative ideas with your teams.
Note that this is not the finish line. This is a starting point to continue to grow and evolve with the ever-changing landscape, to meet the needs of healthcare professionals and patients.
We’d like to extend our gratitude to all the industry members of the Creative Committee who took time to share challenges, discuss the advertising landscape, listen to the regulatory concerns and work collaboratively with PAAB to refine the creative imagery discussion.
Special thanks to Mike Spelay (bMod), Andy Leeson (Wellworth and Best), and Konstantine Polanski (Point05 Health), for driving the revisions from the first draft document and creating meaningful examples. Thank you to the bMod team for generating creatives to help capture the principles outlined throughout the document.
We look forward to implementing these new approaches with you and continuing the conversations.
Hi,
Are controlled drugs listed under Schedule I of the Controlled Drugs and Substances Act subject to the same marketing and advertising regulations as opioids?
Is it permissible to create and provide promotional materials for controlled drugs to healthcare professionals or medical staff?
If not, can product fact sheets still be distributed?
