Have you ever received a request to do something that your gut told you wasn’t the right approach from a compliance perspective? It may have been a déjà vu moment, transporting you back to the numerous policies and SOPs you’ve read that outline the expectations for your role. I view building compliance strength in the same light as going to the gym. Building strength in the gym will help prepare me for challenges such as the distance or elevation of a hike. Building our compliance strength will help us navigate unexpected challenges in the field, which is an important component of the art of being an impactful MSL. Understanding of the “why” behind your company’s policies, procedures, and guidance will strengthen the base knowledge from which you can draw when an unpredictable situation arises and your gut chimes in. At the recent Medical Affairs Professional Society (MAPS) meeting, I attended a workshop led by Adeola D., Pamela Lonzer, and Monchiere Commodore, who reviewed some important reminders and led us through a good discussion:

·        Upholding the integrity of the science we discuss is critical. Fair balance and scientific balance are critical during scientific exchange. Enough said!

·        The “Safe harbor” for non-promotional scientific exchange has guardrails, even with the new SIUU Communications Draft Guidance. Are you confident you know how to work within these guardrails as defined by your company?

·        Minimizing the risks or overstating the benefits of a product during a conversation with an HCP is misbranding (and a false claim). How do you ensure balance in each conversation, every time, even with the KOL’s with whom you have a long relationship?

·        There are clearly compliant and non-compliant ways of working in with commercial, there is a lot of grey in between. How does your company interpret that grey and do you reflect that interpretation in the field?

The workshop included an activity where we identified risks, assessed severity, determined the control, and monitored the outcomes. It was valuable to hear the different perspectives from others on their interpretations and experiences. There was no “group think” at our table! It was a good reminder that grey can be interpreted in different ways and depends on the space you are navigating (i.e. launch, device). Each company has a different risk tolerance which will be reflected in the types of activities that are implemented.

When has your gut chimed in to alert you to assess the compliance of a request?