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Jennifer Carroll

Is the product dual schedule or only “ethical”? Is it for the treatment of a schedule A disease?

One would need to consider schedule A and dual scheduling to establish which DTC regs are applicable (and consequently the degree to which they differ from HCP regs). If we assume the product is not dual scheduled and its use is not on schedule A, it is likely that the same imagery and heading can be used. However, there are instances where that is not the case because the HCP looks at the ad from a different vantage point as the general public (I.e. the same message can convey different/additional meaning for the HCP). Also, the HCP piece may contain different content that impacts the context in which the image and heading is interpreted.

One way to make sure the same image can be used is to submit an opinion to PAAB for the DTC along with the HCP piece.

charlton

Thanks, Jennifer. Love the dog, by the way!

kshulist

Hi there,
Could you please provide me with some clarity around "prognosis"-type claims in a branded APS. For example, claims like, "People with diseaseA associated with mutationB have a worse prognosis" or "The five-year survival rate of disease A is 40%". (In the first example, the drug would be indicated for patients with diseaseA associated with mutationB).

My questions are:

Can you use these types of claims in a branded sense as long as they are clearly portrayed as "disease information"? And follow-up: would it depend on whether the product has OS data or not?
These feel like they might fall under the burden of disease guidelines, is that correct (I'm thinking it could be "sequelae")? The BoD guidance says that sequelae for which the product has no data should not be emphasized - does that mean we can still mention them in an unemphasized manner?
If you can use them in a branded sense, what kind of reference support do you need for them? If (2) is correct, would the references be the same as for burdens in section 3 of the BoD guidance?

Thank you so much for your help!

Jennifer Carroll

Happy Almost Friday @Manufacturer and @Agency

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Username

Thanks @Jennifer-Carroll . To be more specific, the product falls under the "Ethical" schedule. Would this affect your response? Thanks!

Jennifer Carroll

Good afternoon @Username

As previously noted in the question "Comparative therapeutic claims of schedule 2 products in DTC setting", the term “Schedule 2” is quite broad. Could you please clarify by specifying the federal drug schedule?

With respect to your question about whether there is a “clear regulation that would forbid DTC and HCP from having the same visual or headline,” this depends on how “clear” is interpreted. There is no direct statement in the Food and Drugs Act that explicitly addresses this scenario. However, the principles governing advertising regulations are outlined across several regulatory and guidance documents.

The nature of the claims and visuals would influence how such a case is assessed. Additionally, the idea that materials could be independently reviewed and approved by each “respective agency” may present challenges, as this would assume both agencies are aware of each other’s submissions, which is not always the case.

We would therefore recommend submitting the materials for an opinion to ensure clarity and alignment with the applicable standards.

Jennifer Carroll

Hey @charlton

Great question. You can provide a link to the HCP and to the patient. On the landing page, you can present the product name and the DIN login or HCP verification login. The site cannot link back to the parent company site or any site containing the PM. There should be no logo or promotional content on the pre-gate landing page. You also cannot use Search Engine Marketing (SEM).

Jennifer Carroll

Good Afternoon @Manufacturer and @Agency

Another quarter in the books. The PAAB Quarterly Tag and CEI Reports have been updated to contain data for Q3. See the Tag Report here and the CEI Report here.

Please share with colleagues and promote awareness that PAAB publishes these results quarterly. Remember that tags and the Customer Experience Index (CEI) are the most effective way to help PAAB track trends and improve experiences.

If there's more you'd like to know in Q4, let us know in the comments below. Hope you're enjoying the snow.

Thank you
PAAB

Username

Hi PAAB, is there a clear regulation that would forbid DTC and HCP from having the same visual/headline for a schedule 2 product, if the creative & assets are approved by the respective agencies for the appropriate audience?

charlton

Assuming that a url is only provided via a PAAB-approved APS, if a website is being designed for a controlled drug, are there any differences in what is allowable versus for a prescription product. For example, can the brand name be on the gate page, can there be a patient section (DIN gated) where the contents of a PAAB-approved Patient Brochure are provided? Are there any specific restrictions that affect controlled drugs when it comes to websites?
Thanks.

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