HOW MUCH DO YOU KNOW ABOUT: THE ROLE OF THE COMMERCIAL SUPPORTER
CASE STUDIES: How To Stay Out of Trouble as the Commercial Supporter

The following are real happenings.

A Rep, a Product Manager, and the FDA go into a bar…

A rep comes to the product manager and says, "I’ve got this great CME activity lined up with dates, speakers, and content already completed by our team. It has to be CME because we are going to present data that is "off-label". The ROI predictions are good. All we need is a CME provider!"

    You think (click on a letter):
    a. "I don’t know if that’s a good idea, but if the ROI is good, my superiors will think I’m doing a good job."
    b. "From a CME Web site I was reviewing recently, I think we should step back here and rethink this."
    c. "Let’s consult a CME provider and see how the process should go so we don’t put our company in jeopardy and make ourselves look bad to our physician customers."
    d. "Boy, I wish I had a sandwich right now!"

The Sliding Slope…

There’s a CME activity in the works. The Letter of Agreement is signed, the faculty have been chosen, and the content is in process. There is a third party communications company creating content (along with the faculty) who is the main contact — they are joint sponsoring with the CME provider. Along the way, a major competitor releases some information about how much more quickly their drug works. The product manager immediately contacts the communications company and tells them that they MUST get several new slides into the presentation, created by the marketing group, to counteract this competitor info. Emails fly. These slides must be incorporated! More email. The communications company, perhaps concerned about maintaining their business relationship, agrees to try to convince the faculty that these new additions are necessary. The faculty member, perhaps worried about her relationships for future honoraria, agrees to have the slides added. The CME provider does not even see the changes because the communications company doesn’t get final approval from them due to the short timeline. These slide additions make the presentation unbalanced in the commercial supporter’s favor. After the activity, the following happens:
    1. A physician who attended the meeting notes this glaring imbalance and contacts the ACCME and the FDA.
    2. The commercial supporter is contacted.
    3. The product manager’s supervisor is contacted.
    4. The legal department is contacted.
    5. The product manager’s computer is confiscated for investigation by the legal department, all emails reviewed.
The product manager is quickly shifted to another team, far, far away.
Note that the CME provider could also be chastised in this scenario and could potentially loose accreditation status from the ACCME. However, because they were not aware of what had occurred due to the joint sponsorship, it was out of their control. The ACCME would most likely recognize this.

This scenario is a serious situation, not just because the regulations weren’t followed. No matter what money exchanges hands here, patients would be the real losers. If the competitor’s drug works more quickly, then that information should be presented in a balanced way, not drowned out with data from the other side. In most cases, the product manager’s drug was probably better in some other area, like safety, perhaps. CME is intended to allow physicians to choose drugs for their patients based on the facts. Think of it this way - educating physicians about disease states can increase prescriptions for everyone.

Remember, the ultimate goal of CME is to improve patient care.

The best way to handle this situation would have been to contact the communications company and let them know about this new data. Have them discuss with the faculty the best way to include it in the presentation, if the faculty agrees it’s important. It wouldn’t hurt to make sure the CME provider is the final approver by simply asking the communications company to ensure the provider sees the final materials. Remember, though, as a marketing person, you shouldn’t be reviewing content along the way. If the communications company you picked is allowing you personally (as opposed to your scientific staff) to make comments along the process, then they may not understand the rules.

Quick Tip: Cover Yourself, Stay out of the content!!!

If you have other CME questions that you would like answered, do not hesitate to Contact Us at The FCG Institute for Continuing Education.
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