Clarification regarding digitization of APS: Helping healthcare product manufacturers plan for the evolving COVID-19 operational context.
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.
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!
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.
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.
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)
@Jennifer-Carroll Thank you Jennifer for the quick and clarifying response. Super helpful!
@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'....
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.
@Jennifer-Carroll Ah. Thanks for clarifying. I misunderstood that question 466 was in relation to attaching an approved template, and not just for a regular email. Thanks for the quick response!
Can you clarify if the same guidance (if the entire PAAB approved print document is converted with no change in copy, flow or layout, it would not require an additional PAAB preclearance/review) is applicable for conference material? Many conferences have now gone virtual and allow for a virtual booths and/or pull-up banners.
Hey @AmandaM , interesting case.
It’s difficult to imagine a situation where some aspect of the piece is not going to change.
For example, the addition of a name to the document (PDF) would be considered new copy. Similarly, copy prompting the delegate to download or access the PDF (via text or image) would change the copy and render point 1 of the Clarification regarding digitization of APS document not met.
Another consideration is the manner in which a delegate accesses the content (PDF). For this, please consider the guidance provided in the Advisory on Disclosure of APS Placement Details which reflects the understanding that content reviewed will have run-of-site/random placement within publications or platforms. If the positioning of an APS is not random, and is instead by design, this must be disclosed to PAAB when the APS is submitted for review.
In summary, there are many aspects about the piece and access of the piece within a virtual conference which would create some form of context which goes beyond the direct digitization of a print piece to a PDF version.
If there are additional aspects not considered above, specific to your case, you can always use the PAAB opinion services for a more thorough review of your use case.
@Jennifer-Carroll Why would Fair Balance be required for the document name "Brand arthritis efficacy LB". There is no mention of results - good or bad. It's simply a label - not data.
Hello @tmcd ,
Please see PAAB Q&A 758
I'm sorry, but I'm still not clear. PAAB Q&A 758 states "discussion of disease content". We're not discussing or implying anything about efficacy. It is simply a label to help differentiate amongst APS documents in the naming convention. Can you please further clarify. Would this be addressed by using the term "efficacy profile" instead?
Good Morning @tmcd,
The rest of the sentence quoted above reads “discussion of disease content would suggest the therapeutic use without properly limiting to the specifics of the products indication.”. The copy “arthritis” is discussion of the disease which suggests the therapeutic use.
Any HCP product advertising that identifies a disease must, disclose which patients the product can actually be considered in. In the hypothetical example, the product is not for anyone who has arthritis. The presence of the indication consequently triggers the need for the lowest level fair balance statement.
As noted above, "Drug X efficacy profile" (without mention of the disease/condition) would NOT trigger the above requirements.
palanski last edited by
Hello! Hoping you could clarify what is to be supplied to PAAB to satisfy the following: "The submission of the email template should include detailed information regarding the naming convention for email attachments."
Given you state above that an "exhaustive list would not be required" for all documents to be distributed via the template, but then go on to say that the quoted example "does not provide sufficient information for assessment", it is unclear what PAAB ultimately requires.
Good Morning @palanski
Absolutely we can help clarify this.
An exhaustive list would be a complete list of every title, applied to every attachment which could be attached in the email template under review. As noted above, an exhaustive list is not required.
The initial copy “The submission of the email template should include detailed information regarding the naming convention for email attachments" which the copy “Sufficient information for assessment” applied to, speaks to providing a clear definition of the naming convention. The example provided and challenged was a definition of "product name_document name_internal code.PDF". The copy “document name” is not detailed information regarding the naming convention as the interpretation of “document name” is open ended. I could title my documents anything, such as “Best RA treatment since sliced bread” or “Better than all the rest”. Something similar to “Document type” with examples like “Leave behind”, “Dose card”, “Reprint carrier” etc. would be considered more detailed information for assessment. It is also beneficial to set restrictions that will be enforced, such as “no mention of: therapeutic area, outcomes, patient populations, etc.” with the goal being that the names should not have claims or create a link between brand and therapeutic use that would trigger the need for additional qualification and indication/fair balance within the email content.
Ultimately, PAAB requires a detailed description of the naming convention so that we can make the assessments mentioned above.
Hoping for clarification on the naming convention of materials for products that have more than 1 indication:
For example, we have 3 different patient brochures (1 per indication) for one of our products.
Since we cannot use the therapeutic area as an identifier in the title and are restricted to "type of tool", how should we approach the naming of these three materials such that it is clear for which indication the material corresponds to?
Currently I have them as "Patient Brochure 1", "Patient Brochure 2", and "Patient Brochure 3" which is unclear and could potentially lead to mix ups by the customers disseminating to patients. Thank you in advance!
Good Afternoon @aboucouvalas
It’s important to note that the naming convention mentioned above is to allow for pieces to be attached to a standardized email template and therefore will not have the indication and appropriate level of fair balance associated with it. If you wish to send an email with three different patient information tools for one brand across three indications, it may be worth considering a branded email. At this point, the email could contain the appropriate level of fair balance and allow for the identification of the therapeutic area within the naming convention. Note that should you take this route, the name of all attached tools should be included in the email submission.