Clarification regarding digitization of APS: Helping healthcare product manufacturers plan for the evolving COVID-19 operational context.

[Jennifer Carroll]

Hey @Lisa

Thanks for the questions. Here are some further clarifications:

1. Content changes to ongoing APS could be resubmitted for review under the same file number providing there are only small modifications/moving of content. If there are large changes such as additional functionality, (e.g. tabs, buttons), a new file may be requested. If the piece has already been approved, it will require submission as a new file for any post approval changes consistent with usual PAAB policy. In both scenarios, if a new file is required, please reference the past file numbers to facilitate review. We will do our best to expedite the review for you if you let us know which of your submissions to prioritize. The simpler the changes, the sooner we can provide a response. We suggest noting the request in the submission letter AND in a separate email to review@paab.ca so that our admin team notifies the reviewer. If there are multiple submissions of this sort for a product, submit them on the same day to take advantage of the series fee.
2. For ongoing files that reach approval stage, we can start the approval period up to three months post approval. If it is a new submission, set your date of first use on the submission form accordingly. That way you’ll still likely get the full-year approval period. Note that we also have an extension policy for extenuating circumstances. Should social distancing persist well into the future, we’ll consider what can be done from an extension perspective.

[Jennifer Carroll]

Hello @Karine

As always, PAAB will do its best to achieve timely reviews based on workload. In 2019, our average time to first response was 6 days. As mentioned above, quoting backfiles and advising admin of priority files will help facilitate our timelines.

Thank you for reaching out.

[Donna]

1. For the generic email, can the representative send the digitized APS unsolicited as an FYI (i.e., a HCP request is not required; a meeting did not need to be on the books)

2. Do they need to be scheduling a meeting to discuss the APS within the email? or is a blanket sentence like “let me know if you have any questions/comments about the attachment” sufficient?

3. Can the company send the email with the digitized APS to HCP’s for whom they have consent; the correspondence comes from the company and not the individual representatives.

4. Can we submit 1 generic email to PAAB that has free text places for either brand OR disease in the same email.

5. 1 generic email for subject [Brand] OR [disease] Update: Rep can only include the brand or the disease and not both.
   OR do we need to submit 1 unbranded and 1 branded generic email?

[philippacrabb]

Hello,
We are intending to develop a generic, unbranded email so we can attach branded or unbranded content (via separate emails as you have indicated) and send to HCPs. If we attached branded content, do we need to include the fair balance and indication content appropriate for the attachment in the covering email too, or is it sufficient this appears in the attachment alone? Thank you.

[philippacrabb]

This post is deleted!

[Jennifer Carroll]

Thanks @Donna, please see responses below:

1. Yes – As per the first paragraph under “Dissemination” : “Emails used to distribute digitized APS in an unsolicited fashion DO NOT fall under the person-to-person correspondence exemptions in the PAAB code or advertising regulation exemptions in the Health Canada Policy Document “The Distinction Between Advertising and Other Activities”. These emails with attached APS are subject to PAAB review"
2. There is no need to schedule a meeting within the email. However, a sentence similar to the above could be considered if the manufacturer wishes.
3. This is an activity. We would recommend consulting your internal legal department. PAAB reviews the content to ensure it is inline with advertising regulations.
4. No – As per the second sentence of the second paragraph under “Dissemination”, “It can include free text portions for transactional elements (e.g. greeting, date and time of phone meeting, sign-off)." Free text is not an option for brand or disease information. Please see PAAB Q&A 748
5. Two separate submissions would be required.

[Jennifer Carroll]

Thanks @philippacrabb.

In the submitted file, you will be showing how the attachments will look and feel. In the document above, you will also note the statement “The submission of the email template should include detailed information regarding the naming convention for email attachments." PAAB will comment on the naming convention if there are concerns. To minimize the requirements for the full fair balance within the body of the email, ensure that the PDF names are claim neutral. This means, think of it the same way as you would a subject line. “Brand efficacy profile” “Brand safety profile”, “Learn about the MOA of Brand” would all be neutral copy which would not prompt the inclusion of fair balance within the body of the email. However, an attachment name similar to “Brand arthritis efficacy LB” would require indication and fair balance in the body of the email.

[Einstein]

@Jennifer-Carroll With regards to naming conventions, are we required to submit a full, exact list of all PDF names that are planned for distribution? Or is it sufficient to provide a generic outline of the naming system to be used, for example:

"product name_document name_internal code.PDF"

Thank you.

[Jennifer Carroll]

Hey @Einstein

As mentioned in the guidance, “The submission of the email template should include detailed information regarding the naming convention for email attachments". As such, an exhaustive list would not be required. However, in your current example, “document name” does not provide sufficient information for assessment. As you can see in the example above, a document’s name could be “Brand arthritis efficacy LB” which has fair balance requirements that would need to be addressed in the email.

[Einstein]

@Jennifer-Carroll Thanks very much! One last question about these email templates: do they have to bear the PAAB logo on the emails themselves, or is it sufficient that the attached APSs have the logo displayed?

[Jennifer Carroll]

Hey @Einstein

The email templates should bear the PAAB logo to indicate that they have received independent review and approval.

[HealthyMind]

Hi @Jennifer-Carroll,
Can you clarify if there is any guidance on proximity between branded and unbranded communications? As we understand that branded and unbranded tools require separate emails.

[Jennifer Carroll]

Hey @AmandaM
The PAAB has not created a specific set of guidance on proximity as there are multiple factors which could weigh into the decision of proximity creating linkage. As a general principle, the sponsor should be able to make the argument that the pieces (branded and unbranded) are not linked in any way, including but not limited to temporal and physical proximity. With this in mind, when thinking about proximity, it would be hard to defend that emails sent sequentially within an hour are not linked. However, emails sent days apart would present less risk of being linked. The PAAB can provide an opinion on ‘standard practice rules’ set up by the sponsor.

[jen_kent]

Hi @Jennifer-Carroll,

If we've already received full approval of our email template, but are now submitting a new APS (e.g., one-page PDF) that a client would like to be able to email out using that template, do we have to resubmit the template as a new file (even though nothing else has changed) or can we just include the what would be the "attachment name" in the new APS' submission cover letter?

Similarly, if one of the files that we had specified in the email template is expiring, but is renewed/updated slightly, do we have to resubmit the email template, or just include mention that it "replaces efile 9XXXX in the email template (efile 10XXXX)" in the renewal's submission cover letter? (given that we always confirm that APS will only be disseminated within their approval periods anyways)

Thanks very much in advance!

[Jennifer Carroll]

Great question @jen_antibody

Assuming that the email template was submitted to meet the restrictions outlined in the second paragraph under “Dissemination” above, you would not be required to resubmit the template. Yes, you should provide the “attachment name” within it’s submission and convey that the intent is to disseminate through the approved template (efile #).

No, you are not required to resubmit the template due to updates to pieces which were previously listed through the template.

Let us know if you have any further questions.

[RKpharma]

Hi there,
We are aware of the updated guidance with regards to digitization/distribution of PAAB materials as highlighted at the beginning of the COVID restricted environment. As such we have submitted e-mail templates for PAAB approval that should be used for any unsolicited emails where the reps wish to include PAAB approved materials. The question here is with regards to responses to requests, ie. solicited emails as follow up to conversations between the reps and customers, and guidance around what reps are allowed to send to customers.
Thanks,
Rivka

[Jennifer Carroll]

Hey @RKpharma

A combination of factors cause the response to be provided in a promotional context (i.e., it is provided by the sales representative, it may be linked to advertising through attachments, and it is in response to an advertising communication). The exemption relating to unsolicited requests therefore does not appear to be applicable.

It is therefore advisable to train sales reps to restrict their response email bodies to the type of transactional information which may appear in open text field (see Advisory on the Use of Open Text Fields in APS) such as date and time of meetings. Additionally, the rep should only attach PAAB approved materials (ensuring branded materials are not inadvertently linked to unbranded ones)

[RKpharma]

@Jennifer-Carroll Thank you Jennifer for the quick and clarifying response. Super helpful!

[RKpharma]

@Jennifer-Carroll Hi Jennifer. Looking at the answer to Question 466, confirming a rep would be allowed in a subject line to have a claim neutral statement ie 'Read about the safety profile of Drug X' and then simply attach a PAAB approved asset with no further verbiage beyond 'as follow up to our conversation'....

[Jennifer Carroll]

Hey @RKpharma , in answering this question, I want to make sure we aren’t confusing topics.

In PAAB Q&A 466, the question is “what type of claims are acceptable”. To that point, yes, the type of claim you mention is possible. However the email would fall under advertising and therefore be subject to PAAB review.

The digitization document this question has been posted to, makes reference to an approved template. The scenario described above would not fall under this scenario as the nature of the message has implications for the attached content which would need to be reviewed. You’ll note that in the guidance it states that only transactional elements can appear in the open-text fields. “Read about the safety profile of Drug X” would go beyond that and should be submitted for it’s own review. Any additional requirements would be addressed during the review process based on all copy within the email, including the subject line, which in this example, would prompt fair balance requirements.