Hey @nimisha

We are assuming that you mean “a resource in Veeva which is a PAAB approved HCP email”. If so, yes, it is possible to use patient feedback. Claims should be limited to the program features. If it’s a branded PSP, copy may have implications for the brand. Additional nuances may arise during the review process.

Good Morning @matt-s17

Apologies for the delayed response.

In addition to a letter from med/reg confirming that they are actual patients, the presentation would be required to include the statistically significant data from the study for the endpoint being presented. The images should therefore reflect the average response. It would not be acceptable to select images that show the best-case scenario for patients.

The pictures would also have to be disclaimed with “Actual patient. May not be representative of all patients.”. As with patient images, they should only appear in a clinical context and with the supporting data (e.g., if you’re going to place them on a summary page, the quantification will require repeating).

Hi @chagali-toney-0

Co-promotion of a brand and a separate disease state would be difficult to do in a single email as the nature of the communication inherently links the two features regardless of the look or disclosures. We would recommend two separate communications. Remember that when you link branded and unbranded, everything becomes branded. Q&A 356 provides greater detail around proximity.

Hello @erinmacisaac

We’re in the process of building out the 3.0 training which is be similar in format to last year (case based) and directed at a “3.0 level”.

If there are topics that you think would be beneficial for a “3.0 level”, please post them below or email them to info@paab.ca and we’ll try to work them into the learning. More details to come.

Hey @maryssa

In theory an "only" dosing claim can be made. The specific claim and/or copy required would be assessed during the review based on the indication and limitations of the "only" feature.

Yes, a disclaimer is required when making a non-clinical claim. In this example the copy is inherently comparative against the dosing of all other products. The disclaimer would be required to read something similar to “Comparative clinical significance unknown”.

The extent of the dosing copy will be dependent on the dosing in the TMA, the overall message of the piece and any class features which may impact the interpretation of the claim. In general, you will also require copy reflective of “for full dosing and administration, please see the Product Monograph”.

A letter from medical/regulatory confirming the nature of the “first” and/or “only” claim. The sponsor should also recognize in that letter, that they are aware that it is their responsibility to pull all pieces with this claim from the market if it should no longer be true, regardless of time left in the approval window.

Hey @hrj2021

As the piece is being handed out in a consumer space, it would be required to meet the consumer regulations requirements (Distinction Between Advertising and Other Activities). Since the handout appears to have been developed/reviewed as a product specific HCP-patient interaction tool, there may be an inherent link to the brand. We would suggest that this piece be submitted for a DTC review to ensure there is no brand mention, no link to a brand, and it meets the consumer requirements. It would also be pertinent to disclose the nature and other copy at the booth as links may make distribution of the piece unacceptable.

Hello @au3010

Yes, a non-indexed, non-guessable URL with controlled distribution (e.g., through HCPs), would not require a DIN gate. The manufacturer is responsible for ensuring the controlled distribution of the URL.

@jennifer-carroll Many thanks

Hi @nhem

The entirety of 7.4 states:

Corporate Advertising / Promotion Systems (APS) These are designed to create and maintain a favorable image of a company, its products and its services. See Section 1.5: Materials Not Subject to PAAB Review. These systems may be used at any time at the discretion of the advertiser but must be submitted for PAAB preclearance prior to publication. They must not contain therapeutic or other claims of product merit or status. They may contain:

1. A general statement about the pharmaceutical company, its products and its service(s) and policies.

2. A partial or complete list or illustration of products manufactured and/ or distributed by the company, along with their respective therapeutic or pharmacologic classifications

3. Product information does not have to accompany corporate advertising.

This therefore conveys that corporate messages which do not contain product information or product lists (direct or indirect) are exempt per 1.5. The remaining scope of corporate advertising is subject to review per 7.4. As an example:

“Company X employs 2000 Canadians” is a corporate message that does not speak to products or product lists. This message (as a stand-alone message), would be considered exempt.

“Company X is the proud manufacture of Product Y” is a corporate message that contains product information. This APS would be subject to review.

“Company X is dedicated to research in the treatment of condition Y” would be subject to preclearance as it alludes to products when it states “treatment”.

The copy “Product information does not have to accompany corporate advertising” refers to the fact that corporate messages may make mention of products, but do not require the fair balance or TMA link if they meet the spirit of a corporate message and are not brand promotions.

Hello @au3010

We would need to see the whole piece to make an assessment. We suggest submitting for an exemption request.

@cchristopoulos

In general, PAAB should be informed of all changes to an APS post approval, including re-directs for a QR code as it would deviate from what was approved. While the re-direct would be a PAAB approved branded APS, the context of the original message in relation to the new APS is a consideration. It can be forwarded to PAAB as an FYI initially and we can determine whether that is sufficient or if an update would be required.

@fernand

Our previous response was provided with the understanding that Product B had a similar indication.

Where Product B does not have an indication at all, there can be issues with potential off-label promotion. It would be suggested to not use the Product B logo in Product A advertising in those cases. Use of Product B’s brand name could be considered when presented in the context of the PM for Product A, i.e. in a cautionary manner only. It should not be designed as co-promotion of Product B. As the respective indications and PM dictate how Product A and B can be presented, we suggest submitting for an opinion with the PMs as there may be nuances within that may not be addressed as a general question.

Eg. Product A is indicated for combination use with Product B for metastatic melanoma. Product B has no metastatic melanoma indication at all. If the APS is highlighting use in metastatic melanoma and includes Product B’s logo, this would be considered off-label promotion for metastatic melanoma as Product B has no such indication.

@dmauri

PAAB does not approve exempt materials. Our review service provides an opinion on whether submitted material is exempt from review. As such no proper review against the PAAB code and supporting evidence was undertaken with the exempt materials. When exempt material is linked to unbranded PAAB reviewed APS, the exempt file would be subject to PAAB review because of the linkage. The exempt material would be reviewable as unbranded, editorial APS per section 7.5 as well as applicable codes sections with respect to substantiation for the claims within.

In the example presented, the previously exempt website would no longer be exempt and should be submitted for full review. Similarly, the exempt website may not host PAAB approved unbranded APS as the linkage would render the exempt website reviewable.

@jennifer-carroll said in Sharing DTC info with HCPs:

he unbranded communication linking to it are exempt from PAAB preclearance when targeted

Thank you. That really helps aid in understanding. Have a great weekend.

Hey @palanski

Great question. PAAB’s strategic plan for 2023-2025 includes a focus on increasing the extent to which HCPs value health product advertising and industry-generated patient information. This is the primary motivation for the shift outlined in the disease burden document. This shift is one element of a multi-pronged approach towards that aim. The standards outlined in the document were generated in consideration of our global benchmarking and stakeholder consultation activities.

While health product manufacturers’ have expressed a long-standing desire to provide more detailed presentations of disease states, it took some time to establish a set of standards that effectively aligned that desire with the interests of patients and HCPs. The objective of PAAB is to ensure that disease information (including burden of disease) does not suggest use and efficacy for outcomes which the brand has not been demonstrated to address. This objective remains however PAAB has looked to explore ways that we can meet this objective while allowing more latitude on disease presentations.

In short, the document seeks to outline principles that will mitigate the risk that the disease burdens be interpreted as outcomes that the drug can improve. The document also reiterates the requirement that the disease information and descriptions of disease burden must pertain to the promoted product’s indication.

Our hope is that manufactures will view the guidance document as a collaborative means to providing greater flexibility in relation to disease information presentations in HCP advertising, disease information presentations in patient information, and disease burdens conveyed in creative imagery.

Hello @karen-taylor

The terminology “HCP/patient interaction areas” was used to be a broad and all-encompassing term to include the office, waiting room, digital space etc. where the HCP has control over the content that is in the space. PAAB Q&A 240 provides additional clarification.