Disease awareness Pre-NOC
-
Can a company create a disease awareness pieces on a therapeutic area they do not have any product approved yet (Pre-NOC)? For example, if the company creates a website or an article for a magazine/ journal that does not allude to any product, can this have the logo of the company? Is there a difference if the audience is General public vs HCPs? Is it Ok for a pharmaceutical company to include information about the disease in the social media platforms of the company?
-
Hello @sil
There are ways in which a company can create content which speaks to a disease state they may not yet have a product in.
An institutional APS can convey that the manufacturer is committed to conducting research in a specific therapeutic area. They must not contain or imply any product claims, or state or imply that a new product or indication is coming soon. These pieces should be submitted to PAAB as they relate to investigational drug research.
An editorial APS which is intended to increase the HCPs awareness and understanding of a therapeutic area is acceptable. The APS should not contain the message that a new product (or indication) is coming soon as this would contravene section C.08.002 of the Food and Drug Regulations. Even if pharmacotherapy is not discussed, pre-NOC editorials about physiology or pathophysiology should be submitted as they relate to investigational drug research.
As a cautionary note, creating an entire editorial campaign may be considered pre-NOC advertising as this changes the frequency of messaging and breadth of formats/media used to convey the content.
Audience is always a consideration and the type of message will impact whether it can be presented to the general public or will require limitations to HCPs.
While it is acceptable to make reference to a disease state on the company social media, be cognizant of the fact that there should be no link to the product in development. If there are other posts about ongoing trials, recently reported findings, investment in treatment for this therapeutic area etc., this may be considered pre-NOC advertising. Standard monitoring and moderating requirements would also be required.
