Mention of new indication in 1x1 email to HCP
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We’ve been seeing some conflicting information between various sources around whether a rep can include mention that there is a new indication for a particular brand in an email that they send on a 1x1 basis to a healthcare professional that they have relationship with, when they’re requesting scheduling a virtual meeting time (i.e.in Veeva Engage) to discuss further. Given current COVID-19 realities, a rep no longer has the opportunity to be live in a physicians’ office and verbally make mention to them of a new indication and then launch into a further discussion using PAAB-approved APS. So they’re hoping to be able to make mention of the reason they want to schedule an appointment with a physician in that email that they’re sending to book time to discuss virtually.
The email would be a true one-to-one email, and not a pre-drafted email intended to be sent to multiple HCPs where the rep is simply personalizing a greeting line or something of that nature.
Possible to provide clarification?
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Hello @karen-taylor
As per the resource document Clarification regarding digitization of APS: Helping healthcare product manufacturers plan for the evolving COVID-19 operational context, 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. Additionally, the Advisory on the Use of Open Text Fields in APS states that open text fields may be used in APS provided that they do not relate to healthcare products, healthcare product issues, diseases/conditions, outcomes/endpoints, corporate messages or service messages. They may be used solely for personalized greetings or transactional elements (e.g. date and time of meeting). Open text fields must not include other messages, even if they echo messages reviewed and accepted elsewhere in the current or previous APS.As an additional point of clarification, “new indication” is a claim of product merit which should be limited by the indication and subsequently at least lowest level fair balance (see PAAB Q&A 740). As such, the activity outlined above would be subject to PAAB review.
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Hi @Jennifer-Carroll. Thanks for the response. To clarify, the intent of the 1x1 email from a rep to a physician is not to send/attach a PAAB-approved APS, nor to create a pre-drafted email that has open text fields.
The question here is whether a rep could simply send a personal email to a physician (as per PAAB code 1.5, B, and the reference that "Person-to-Person Correspondence" is not subject to pre-clearance) that makes reference to there being a new indication for a particular product.
We understand that reference to a "new indication" is a claim, that warrants low level fair balance and a submission for PAAB review.
However, how does the exemption regarding "person-to-person correspondence" relate to this? What supersedes here?
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It’s important to apply the principles outlined in these guidance documents and advisories. Regardless of if the message is a marketing claim, such as “new indication”, or an attached digital APS, the purpose of the message is to promote features of the product and therefore the same rationale applies. The Distinction between advertising and Other Activities mentioned in the previous response, outlines advertising versus other activities and therefore sets the boundaries of advertising. If the HCP has not asked the rep for the information in an unsolicited manner (i.e. the interaction has been initiated, or information has been offered up by the rep in an unsolicited way), it would not be considered exempt under the one-on-one correspondence section mentioned in the question (see PAAB Q&A 173).
To summarize, a rep-initiated person-to-person promotional activity is not exempt
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Thank you @Jennifer-Carroll. Appreciate the additional clarification. Helps to have this in writing for alignment across various stakeholders.
