Forum

Jennifer, what about an image of an Rx pad in APS with "dispensed as written" copy on the image?

A published clinical study has mention that there was "early trial cessation was recommended" in the upfront abstract section of the the paper. Can we make mention of this in APS? In particular, if the APS announces a new indication (which carries low Fair Balance) and we add mention that the trial that supported the indication had an early cessation (no mention of what the results were, do we need high Fair Balance and what other data is required for it's inclusion?

We are working on updating the pre-gate page to our dual patient/HCP branded website. We want to include a message that creates awareness of an available financial assistance program. We know that, this message would be considered beyond “administrative” messaging, so we would include the standard “brand.ca is open to the general public”. Can you provide guidance as to whether the following messages could be acceptable pre-gate:
(1) Learn about savings at brand.ca
(2) Learn how to save at brand.ca
(3) Go to brand.ca for a discount/savings card
(4) Go to brand.ca for help with costs
(5) Go to brand.ca for payment support
(6) Get payment support info at brand.ca
(7) Get a pharmacy card at brand.ca

If an APS, such as a patient booklet that discusses the disease state for one of the brands, directs the patient to the brand's website and they land on the landing page that has 2 brands, does that present an issue for including the second brand on the website pre-gate page?

We plan to develop an unbranded disease state leave behind. To help ensure medical accuracy, we'll consult with a physician. No grant/monies will be provided to the physician.

Are we able to include an acknowledgement statement in body font size at the end of the APS. The statement would include the name of the physician and would acknowledge that they contributed to the development of the APS. Can we include such a statement?

The wording of the statement has not yet been finalized. Are there any "watch-outs" that we should be aware of?

Thanks.

I am creating a new landing page for a website. For efficiency, I want to have the landing page to include the logo for 2 different brands. The patient or HCP would click on the section of the page that has their applicable brand/logo and enter the information required for entry (i.e., DIN in the case of the patient). Would this be allowed given that no therapeutic area would be disclosed? Would it make a difference if at the top of the page it said something like, "Brought to you by [company x} and then below it the 2 logos. In both cases the logos/sections would be separated by different background colours.

Jennifer, I can't for the life of me find the support to your comment in the Food and Drug Act. I was hoping to annotate the document to send to the client. Can you direct my eyes i.e., section number and page. Thanks.

@jennifer-carroll said in 629 - Hi there, Can the wording "NOW APPROVED IN CANADA" be PAAB exempt for a 2nd indication? Thanks:

he Food and Drug Regulations prohibit discussion of the approval process within advertising

@Jennifer-Carroll Does the note regarding the Food and Drug regulations not allowing us to use the term "approved" in a message still apply in 2024? Wanted to ask given that this response is from 2019. Thanks.

Jennifer, the Guidance document is not clear on the turnaround time for submissions immediately post-NOC with the final Product Monograph. Would any ARO options be available? Would it be a standard 10-day turnaround? Would it be shorter?

With the new Pre-NOC Guidance document, is there a limit to the number of submissions (rounds) we can make for an APS being reviewed during the pre-NOC period?

We have a situation where our brand has 2 indications in 2 different therapeutic areas. We wanted to run with brand.ca but realize that if a patient prescribed the brand for TA #1 is directed to the site, we can't mention the indications for TA #2 as that would link brand to indication for an indication that the patient was not prescribed. We were informed that this is the case when we tried to create an enrolment form that listed indications from 2 different TAs. I was wondering if PAAB has reviewed other brand sites with this situation and how it could be addressed in the URL.

Ok, I've scoured all communications, PAAB responses and guidance documents. From what I can tell, I can mention brand and TA/disease state in the body copy of the RTE. It's the mixing of brand and TA/disease state in the naming convention that's the issue. Right? For example, could I mention the brand name and multiple sclerosis in the body copy and then attach PDFs with naming conventions that mention brand name but not TA/disease state?

Jennifer, you mention "Fair Balance". If the brand name and therapeutic class is mentioned, but no claims, would the requirement only be for low Fair Balance?

Tina

If we create a general email for a brand, can the attachments (within the same email) include PAAB-approved branded APS, clinical publications (i.e., pivotal studies cited in the Product Monograph) and the Product Monograph?

Our parent company has created booth materials for an international conference being held in Canada. According to the IMC Code this must be submitted for local Med/Reg review. The Canadian Med/Reg review has requested that the Global brand logo be replaced with the Canadian logo and also that the global safety information be replaced with Canadian Fair Balance. If the materials are updated to include this content, would they still be exempt from PAAB review given that the materials were created outside of Canada and not by the Canadian affiliate?

Is there any document or insights on what company representatives in a branded booth can and cannot do. I know that they cannot speak to off-label messages and that they cannot distribute unbranded materials. Are there any other things we should be aware of and train our representatives?

@jennifer-carroll One more question, can unbranded patient and HCP websites (post-gate) link to corporate PP and TOU pages?

I understand that the pre-gate for branded patient and HCP websites cannot link to corporate Privacy Policy (PP) and Terms of Use (TOU) due to restrictions set out in Section C.01.044 of the Food and Drug Regulations or Section 3 of the Food and Drugs Act. Can patient and HCP branded websites link to the corporate website PP and TOU pages in the post-gate section of the branded websites?