Clarification on indication inclusion in multi-Product APS
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We are developing a multi-product lowest level APS regarding a Patient Support Program (PSP) for enrolling patients into the PSP via website (online portal). The APS is generalized, one page document with several product names and instructions to access the website and contact numbers. No therapeutic or Pharmacologic claims are available.
Therefore, could you please clarify whether it is acceptable if the indication statement is not included in this piece. Thank you. -
Good Morning @Supriya
We assume that you are referring to a patient targeted APS. As a patient would not have a prescription for all the products, this would contravene the direct-to-consumer advertising (DTCA) regulations (Section C.01.044 of the Food and Drugs Act Regulations) to create a link to the therapeutic use (i.e. indication could not be included) for products they are not prescribed. While the three base levels of fair balance apply only to HCP-targeted APS, a weblink to the Terms of Market Authorization (TMA) links the therapeutic use, a violation of the DTCA regulations.
