Welcome to the inaugural edition of “Dear Lauren,” where our Senior Compliance Specialist answers questions about timely compliance training topics and delves into the best approaches for training in those areas.
This week, Lauren addresses the always tricky and confusing subject of speaker programs.
I am a compliance manager for a small pharmaceutical company in the Northeast. I am concerned that our new sales representatives may assume that they don’t need to worry about the details on speaker programs since an outside vendor manages them for us. We touch on speaker programs in the initial training all reps take, but I am not sure we emphasized their responsibilities enough. Am I crazy to be concerned?
Concerned in Connecticut
First, you are not crazy and I understand your concern. Speaker programs are a hotbed for potential compliance risks. It has been my experience that if you roll out additional training, like microlearning, assessments, and contests continuously to the reps, you’ll significantly reduce the risk around speaker programs.
Here are just a few topics to keep top-of-mind for the reps, and cover in the continuous training, even when an outside vendor is managing the program for you.
Attending to Attendees Concerns
On-going training needs to emphasize the finer details involving attendance. Representatives need to know that transparency laws require attendance to be documented, and it also helps the company evaluate the program. Whether a meal is offered or not, all attendees must sign-in. Reps need to remember no-shows and those who refuse a meal must be documented.
Speaker programs typically have a minimum required number of attendees. If the RSVPs fall short of that number, the program should be cancelled. Verbal commitments do not count.
Off-label questions asked during the presentation are another area of concern. If your company allows speakers to answer off-label questions (not all companies do), the speaker needs to make attendees aware that the question is in reference to an off-label use, and answer only the question that is asked. If that doesn’t happen, the sales representative must interrupt the speaker. Otherwise, the company can be accused of promoting the product for the off-label use. This is a great topic for role-playing during live training.
In addition, physician speakers represent the company. The programs are promotional in nature, so representatives must follow FDA regulations and speakers must follow the approved program. They may not proactively share their experience involving unapproved uses of products.
Speaker Requirements and Issues
I remember one case when a speaker unavoidably arrived late due to traffic and he suggested that he skip several slides to catch up on the time. Make sure the representative knows to stand firm on this. All slides must be delivered.
Another time, the representative realized, after the presentation started, that the speaker added his own slides to the deck. Representatives need to be trained to not panic and cause a disruption, but make note of the incident and notify a manager and the compliance department about the incident. Representatives should remind speakers that in the future, only the approved slides may be used.
Speakers sometimes ask if they can bring additional material about the topic being discussed, to hand out to the attendees. Representatives need to be trained to always let the speaker know that all materials must be approved by their company in advance of the program – whether the request occurs prior to the program or when the speaker arrives. Unapproved handouts are not permitted.
Thank you for your great question!