258 - I am seeking clarification on the recent PAAB advisory Jan 10 2013. If the "Now on Formulary" has codes which we include in the announcement is this still exempt? Secondly if we include codes and incluson criteria is this exempt. Thirdly if not exempt, do we then have to have full PI accompany the Ad. The latter adds significant cost to a relatively simple message. Finally is the inclusion of details on the special authorization or codes mandatory? It would appear from your memo it is at the discretion of the company? Thank you.
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PAAB Code section 2.1 states that advertising material must be accurate, complete and clear and designed to promote credibility and trust. We've been informed by provincial bodies that a formulary message containing coverage codes without also stating the covered use is incomplete and therefore violates the spirit of PAAB code section 2.1. Promotion of coverage codes must be accompanied with complete presentation of the corresponding coverage criteria. This means that when the coverage has limitations/exceptions, the manufacturer has the discretion to choose one of the following alternatives: Simply state "Now on formulary (special authorization)" without mention of the formulary code(s). Presentation of this statement alone, in a manner which is not linked to a therapeutic message in any way, would be exempt from preclearance as per PAAB code section 1.5. A message that includes the formulary code(s) such as "Now on formulary (special authorization Code 123)" requires inclusion of the corresponding coverage criteria, and fair balance. It therefore also requires PAAB review. Note that the coverage criteria may appear in a footnote on the same page as the coverage codes. Note: ALL post-approval changes involving the addition or modification of ANY formulary statements must be submitted for review as new files complete with the formulary references. Such post-approval changes are not accepted as FYI's.
