38 - Regarding Representative distribution of CME Accredited Materials: Can a program supporter have their representatives distribute or base discussions on CME accredited materials ? If I look at the these points it is unclear to me if indeed there can be representative involvement if so, at what level? :1.5(2) Materials that are created by the academic organizers of accredited Continuing Education events/activities may be distributed at the event or to the registrants of that meeting at a later date. 1.5(3) If materials are to be distributed after the event to non-participants of the event by a sponsor company, and product or therapeutic claims, comparative data or statements regarding the sponsors products are included, the complete document must be submitted to the PAAB for review. The respective roles of the authors and the sponsoring pharmaceutical company must be stated clearly on the title page.
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In my view, sales representatives sell products so when they use "CME accredited materials" to promote the sale of a product I.e. "base discussions", those materials may become "advertising" under the Food and Drugs Act and the PAAB Code of Advertising Acceptance. One can make an argument that sales reps should be able to deliver material requested by physicians. However, the company has to demonstrate control mechanisms to prevent the reps from detailing. They can detail "CME" materials but then those materials become "advertising" subject to all the advertising rules, not the CME exemption. A good principle to remember is that just because you call something by a chosen name it doesn't mean it becomes that. CME is a non-promotional activity so keep your reps away from CME activity and your company will not be perceived as breaking the rules.
Remember these are "Exemptions from PAAB review" and in some circumstances the item can still be perceived as advertising subject to other provisions of the Code and federal law. Be sure to read all of 1.5 . The section about the "Distinction Between Advertising and Other Activities" and see the seven questions to ask to determine if something is advertising. Focus on the left side of the code and you won't go wrong. Ask yourself the question "What is my intent in the distribution of this material". Read the whole section.
Remember the content matters. If it does not "focused on or provide emphasis on, the sponsor's product(s)..." it would usually not be considered "advertising" and would be exempt from PAAB review and the code application.
We interpret this section as saying that you have admitted that what you are doing is "advertising" and because your company was responsible for generating the piece through sponsorship it should come to PAAB for review. Just because you say it isn't advertising doesn't make it exempt. Independent production and no focus on the sponsor's drug are key elements regarding the interpretation of whether or not something is advertising.
When in doubt about a particular project, you can ask the PAAB for an opinion. There is no charge for verbal opinions and we charge a fee for written opinions. Give us a call at 905-509-2275.
