DTC/HCP visuals for schedule 2 products
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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.
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Thanks @Jennifer-Carroll . To be more specific, the product falls under the "Ethical" schedule. Would this affect your response? Thanks!
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Hello @Username
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.
