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 Thank you for the quick response!

Hi @au3010,
It is possible to create an HCP directed website with multiple products. Each individual product section would be treated as a separate APS (both from an administrative and from a fee perspective). As this appears to be a specific project with multiple components where acceptability may be context driven and the submission process may be more complex, we suggest submitting for a written opinion to elaborate on the structure and high-level messaging so that we can provide more tailored feedback in consideration of the particular products that this tactic will pertain to.

Hey @taylor-murphy

Assuming “restricted access informational website” refers to a post-gate medical information site (non-advertising), a keyword-based search functionality is still considered best practice. As a reminder, the medical information letter (MIL) responses should only be provided in response to a specific request. Therefore, the keyword-based search functionality should be set out to require narrow searches that yield narrow search results. For example, the user would have to search “[drug name] AND order AND prepare AND dispose” (using the Boolean operator “AND”) for this MIL response to come up. Searching any one word, “order”, “prepare” or “dispose” should not bring up this article as the topics discussed within the MIL response go beyond the single term searched.

HI @au3010

Assuming that the HCP has already been validated, it is acceptable to grant them access to a patient website. When this is being done, the context of the information that they are going to be provided, should be clearly defined. This means that there should be clear copy informing the HCP that they are being granted access to content designed for patients.

Hello @nkh
It would not be acceptable to purchase other sponsors brand/generic name even if it was a product for use before or along with the sponsors product as this would create a link to the therapeutic use of the sponsors product for patients who are on the other brand but not the sponsors. This would be considered direct to consumer advertising which goes beyond name, price and quantity and which advertises the therapeutic use of the product.

Hello @jriordan

Yes, pharmaceutical product can have a webpage. Section C.01.44 of the Food and Drugs Act Regulations restricts the advertisement of a Schedule F drug (prescription drugs), to the general public to name, price, and quantity. If they are prescription and go beyond the limitations of the consumer regulations (name, price, quantity), the content should appear behind a gate to limit to the acceptable audiences (patient information or HCP advertising).

Google Ads or search engine optimization (SEO) generally occurs in the ungated public space and means that the totality of the content (search terms, descriptor, gate landing page and URL) cannot exceed the consumer regulations.

Good Morning @charlton

If the surface of the ad does not prompt the inclusion of indication and fair balance, then yes, it would be acceptable to not include the indication and fair balance on the static ad. If there are claims/therapeutic mention on the static ad or the combination of the static ad and the landing page, this would prompt the inclusion of the indication and fair balance on the first surface with a marketing benefit claim. As a reminder, a marketing benefit claim can be explicit (e.g. text) or implicit (e.g. images).

@jennifer-carroll Thank you!

Hey @gnadeau

Private messages through services/platforms like LinkedIn, Facebook or other social platforms are viewed the same as an email. These are simply different platforms to perform the same action. Per PAAB Q&A 750 if the communication was unsolicited, it should be submitted for review.

@laurelea

Good question. In the same context as described in your previous question Rep triggered e-mails | Forum, a similar principle would apply to the naming conventions for clinical reprints attached to an RTE. Assuming the naming convention is claim-neutral (e.g. Smith, NEJM 2015) as per your example, fair balance would not be required. However, study acronyms are considered different. We review naming conventions in a similar way to subject lines or small space ads, so the RTE would require the appropriate fair balance (level of balance TBD depending on the specific language used in the naming convention) if they contain more than one of the following elements: product name, study endpoint or study name (i.e. study acronym). A combination of more than one of these elements has the potential to allude to a message/claim that requires fair balance.

Hello @Laurelea,

You are correct. If there are no brand-related claims and no reference to therapeutic use, it would be acceptable to not include fair balance within the piece if the document titles are neutral and claim-free, as per your example. For further information on naming conventions for email attachments, please see PAAB : Resources : Document names and descriptions for external use. Please note that the emails would still be subject to PAAB review as they link to advertising. For more information on the submission of email templates, please refer to Clarification regarding digitization of APS: Helping healthcare product manufacturers plan for the evolving COVID-19 operational context (in particular, the Dissemination section).

Thanks!
Danielle

Hey @cchong

Web banners have a small viewing area which amplifies the negative impact that scrolling has on the reading experience. Their geometry combined with the incidental/secondary nature of the attention they are afforded, makes web banner ads particularly sensitive to features that increase the barriers to consumption. The principle that claims and balancing text must be treated equally is always important, but even more so for web banner ads.

Either of the following are appropriate web banner ad approaches*:

The product claims and balancing copy are presented complete and whole within one fixed section. The product claims and balancing copy are presented as one entity and the whole entity scrolls automatically (such that claims and balancing copy are treated equally). A multi-frame APS that flips from frame to frame automatically (such that no action is required for consumption of the entire APS).

*Approaches cannot be combined

Hey @valeries

As there seem to be a lot of moving parts to this question, we will attempt to provide some broad guiding principles.

See PAAB Q&A 169 for key suggestions. While it speaks to HCP quotes, it can be extrapolated to experts in their respective fields (yoga, stress management and goal setting).

If the patient-focused app community is branded, all content accessed through it (including podcasts) would be subject to advertising regulations.
To help reduce the number of post recording changes, we generally suggest having a pre-reviewed script. When this is not possible, we suggest review of talking points so that the speaker is generally guided in the right direction. Post recording, a full script should be submitted to PAAB. Any copy which does not meet the regulations, will be requested to be removed.

A similar thought process can be applied to patient interviews. While it is acceptable to have them, they must meet the limitations of patient information. For example, they should not be promotional. Like in PAAB Q&A 169, we suggest having a pre-approved script, or if this is not possible, a list of reviewed questions. The final script will be required for review and approval.

Hello @nivanov
The section in question (6.6) has been revised and rolled into section 1.5 Materials not Subject to Preclearance of the PAAB Code

Thank you for identifying the old number. We will update the document accordingly.

Hello @kalli,

If the intent of the message is to promote a company sponsored service/offering linked to a brand, and is created and controlled by the sponsor, it is likely subject to advertising regulations regardless of branding elements within the edirect specifically. Remember that when we link advertising and non-advertising, everything becomes advertising. Similarly, when we link branded and unbranded, everything becomes branded.

Hello @hollymed

The PAAB does not require that meta-descriptors for webpages be used. We merely require to review them when they are used. On a side note, there may be reasons to use them (or some other meta data) post gate. For example, some implementations of intra-site(post-gate) search would employ these. But as you’ve pointed out, you’d need to make sure that no content beyond name/price/qty appears in external (e.g. Google) search results. That would be a matter of setting the appropriate robot text. Hope that helps.

Hey @AnetteCPC

Multiple factors can potentially come into play. But the most frequent determinant tends to be whether the video is embedded in the website and is ONLY accessible on the submitted website page, then it can be submitted as part of the same review. If the video can be downloaded, shared or in some way consumed where it is not on the reviewed webpage and complete website, it requires a separate submission. Remember that APS are reviewed as a whole as there may be content on the page or website which creates context for the video, which the video alone may not contain.