574 - I intend to submit a non-branded APS into PAAB shortly. One call to action we are considering is a link to a URL that has been ASC approved (but not PAAB approved). We intend to link to not the whole site, but rather a particular section of the site. Would this subject the entire website to PAAB review?

  • The following answer assumes that BOTH the piece submitted to PAAB and the consumer website are non-branded. PAAB review of the submitted APS includes assessment of the acceptability of the context created by all links to and from the piece. The URL mentioned in your question should be provided as part of the initial submission for the PAABed APS. We would need to assess the appropriateness of the link to that website. If there is no issue linking the PAABed piece to the consumer website in principle, then the PAAB will assess the appropriateness of the link to the particular page within the consumer website which you desired to have as your linkage destination page. Generally, the entire website would not require re-review as it had already undergone review to ensure it meets the requirements for Direct to Consumer Information. The term “generally” was used as there are several potential wrinkles that cannot all be listed in response to a general question. For example, the answer changes if the website was geared to HCPs (even though it might still fall within the restrictions inherent to the consumer audience).

    Keep in mind that the regulations governing materials targeted to each of the three regulated audiences differ.