Hello @kshulist

When the piece speaks to what the drug is for (beyond what is consistent with the Part I indication), how it works, and/or its various features, the piece should contain safety information. The principle is that patient pieces should be balanced and complete. They should not be about overly selective presentations from part III of the PM.

Hey @justineeve

Please see code section 1.5E.

@jennifer-carroll Thank you very much!

Happy Monday @tmcm

Anything that implies that something is “new” would be bound to the one year time frame. As "news" can be defined as “a report of recent events”, this copy does tend to imply that the announcement is in regards to something new.

Hi @dj,

In general, there is no distinction between what manufacturer employees post on a company account and what they post on their own personal account for company unbranded campaigns. A post that contravenes the Federal regulations on a company account likely contravenes those same regulations on an employee’s personal account. Additionally, even when a post is aligned with applicable Federal regulations on a company account, it may be a contravention on a personal account as the context may differ substantially. Ultimately, the company has not curated the content on the employee’s a personal account to ensure the overall context and linkages are appropriate. Posting (branded or unbranded) campaign content blurs the line between corporate and personal accounts. We encourage manufacturers to set internal social media guidelines that convey expectations vis-à-vis social media activity of their employees (and their agents).

@Kiki

Thanks @palanski for the thorough answer. Your response is accurate and complete.

Hi @gbrl88

The NOC/C box should be accompanied by the full indication as per the respective product monograph. Please see our guidance document regarding NOC/C requirements in advertising, Guidance on Advertising for Drugs with Notice of Compliance with Conditions NOC/c. Please also see PAAB Q&A 619 regarding potential exempt messages with an NOC/C product.

Great question @tmcm

Context has always been an important part of our review. But virtual booths introduce so much heterogeneity in functionality, document management structure, and linkage opportunity across different conferences that these contextual factors alone can cause APS which were aligned with the PAAB Code for one conference to be displayed in a manner which contravenes the PAAB code in other conferences.

Examples of important cross-conference differences include (just to name a few):

Whether the risk / safety disclosures are legible by default or require a click Whether the document management structure includes the ability to add document descriptions Whether the document management structure includes search functionality (and if so, whether sponsors can select keywords and determine what the search output states) Whether there is a need to manage the potential for linkages to documents of entirely different regulatory status Whether group chat can be disabled. And if not, which mechanisms are available to ensure the chat is consumed in the context of the needed risk disclosures. Whether there are ways the sponsor can impact the pathway to and from the booth (and whether this can create additional contextual and /or linkage issues)

Most of these sorts of issues are new or amplified in the virtual context and they differ drastically from one platform to another. Clients who assume that they can simply collate previously approved content in a booth without consideration of the platform specific nuances are therefore taking on substantial regulatory risk. Every factor in the partial list above has the potential to cause approved content to be misleading and therefore in contravention of section 9.1 of the Food and Drugs Act.

What are we doing about this?
INFORMING: We’ve been informing companies about these risks for several months, and we continue to do so. The work we’ve done on the communications front is paying dividends as we now regularly have conference organizers, and staff from pharma that deal with those organizers, proactively reaching out to us.

ENABLING STREAMLINING: We’ve been increasingly seeing and accepting virtual booth submissions that are intended to be used across different events. These require some forethought, on the part of the client, into how they can present booth segments in a manner that would not differ materially across platforms (with thoughtful consideration of the heterogeneity between platforms). It also requires proactive consideration about which functionalities they are likely to utilize in future events. This is increasingly realistic as companies have had the opportunity to participate in several virtual conferences thus giving them a better sense of the various platform document management structures.

MONITORING: We have increased our proactive monitoring activities. We’ve increased our presence in large and small specialty conferences alike. We are motivated to maintain an even playing field and we welcome insights about booth executions you come across that do not meet the standards of the PAAB Code of Advertising Acceptance.

Hello @llotter
No, the video is not considered exempt. If the review of the deck did not include the voiceover and/or there are any other additional features (e.g. animations, zoom, pop-ups, footnote presentation etc.), these could all impact the review. This video would require it’s own review.

Hello @username

It is possible to allow the doctor to choose aspects of the patient to build a patient case. However, variable elements which may be subject to quantification, would be required to have support within the piece. These are things like goal statements, comorbidities, concomitant therapy, consequences of the disease/condition, or observed outcomes. Also, undue emphasis (e.g. repetition, a common theme/trend, etc.) on any patient characteristic(s), would require product-specific support within the APS. This includes the “occupation” field if there appears to be a theme/trend related to this field.

Each permutation with quantifiable claims would require a separate submission.

Hi @jennifer-carroll!

Thanks for your reply. Makes total sense. The IMC ethics code for Market Research is quite brief so I appreciate you explaining the practical application. Agree with your conclusion, especially regarding breadth of audience, in this example.

Good Morning @georgian21

Rep emails are considered PAAB exempt when they are true one-to-one communications. If this is not truly a one-to-one communication (pre-prepared, sent to many etc.) it would not be considered exempt. (See Dissemination” in the document Clarification regarding digitization of APS: Helping healthcare product manufacturers plan for the evolving COVID-19 operational context)
To address the various scenarios:

This would be acceptable This would likely be acceptable upon confirmation from the Canadian medical body in the respective field (What constitutes current medical opinion) An assessment of the link and linked content would be made during the review process Link to specific sections would not be acceptable. Linking to the homepage of authoritative consensus guidelines may be considered

Yes @Donna, that would be fine.

@tmcd Please see response to PAAB Q&A 302.

Hi @NatBourre, the distinction is “company logo” versus “company name”. The code does not require a company logo. However, the company name is required on all pieces unless it contravenes other regulations, such as help-seeking messages. The distinction between “logo” and “name” was particularly relevant to the question as it featured concerns about displaying the corporate logo in the midst of a corporate branding change.

@SKW

If independent third party content on COVID-19 is being provided to a patient through a branded patient support program, an assessment of the linkage should be performed to ensure the acceptability of the content within the context of the brand. This remains true even if being sent without the brand logo (i.e. they are being sent the content because they are part of the branded patient support program). PAAB would do an assessment of the linkage to the content which could be done through an opinion file and would be subject to the four day turn around time.

Hello @SKW
In answer to your question, please note that the same email sent individually to several doctors would not be considered a 1:1 message. The message described above could be considered exempt if it meets the limitations of a corporate message with no product mention (e.g. identifying or alluding to a product name, class, category). See code section 1.5E. We strongly urge that the email copy goes through the manufacturer’s internal compliance channels. If there are any doubts that the message is truly corporate and does not allude to products, it can be submitted to PAAB for an opinion (4 day turnaround).

@Jennifer-Carroll said in There are a lot of clinical trials underway on Medical Cannabis. If some of these trials are successful and Medical Cannabis companies can start making claims will they be required to submit their APS's to PAAB?:

Medical cannabis is a healthcare product. Healthcare professional (HCP) advertising for medical cannabis therefore falls within the scope of the PAAB Code of Advertising Acceptance. Currently, medical cannabis advertising may not contain claims, even when directed to healthcare professionals. Advertising materials that do not contain claims are exempt from preclearance for any product category (excluding opioids).
However, specific medical cannabis products that are granted a form of Terms of Market Authorization (TMA) based on evidence relating to particular therapeutic uses will presumably be permitted to make claims in HCP advertising. Of course, those materials would exceed the exemption criteria outlined in the PAAB code and would not be exempt from preclearance.

Thanks Jennifer - this is very informative. We will share this with our customers.