Challenge of Delivering Engaging and Effective Compliance Training to Life Sciences Sales & Marketing Professionals (Part 1 of 6), Brian Miller Ph.D.
Note that the ideas presented in this article are my own and do not reflect the opinions of my current employer.
We were in the third year of a Corporate Integrity Agreement (CIA). The Chief Compliance Officer, disappointed with the low impact of the existing training program, presented the following challenge to me. How can we improve compliance training programs, while complying with the expectations from the Health & Human Services (HHS) Office of Inspector General (OIG)? The training at that time included a 2-hour information-centric online e-Learning course and an 80-slide presentation presented by compliance professionals. The training covered all of the important topics while having the tendency to lull learners into a deep sleep. I was faced with the task of successfully closing out the companies’ CIA and re-engineering the training model to both meet HHS: OIG expectations, and more effectively engage sales and marketing professionals. First, I took the time to learn the expectations of the federal government while researching the appropriate instructional strategy.
Expectations from the US Government
The expectations from the HHS: OIG has changed in recent years. Training and education requirements in recent CIAs include some of the same requirements as years past with the caveat that companies must now have a detailed written training plan. Referring to the 2019 Jazz Pharmaceutical CIA (Section C), the OIG required a written plan for annual training on (a) their compliance program, (b) all job-relevant Federal healthcare programs, FDA requirements, and the companies’ policies and procedures. The training plan had to include training topics, length of training, scheduling, and the format (e.g., online vs live). Those were the only requirements for the training program. What does the HHS: OIG mean when they refer to “applicable Federal healthcare programs and FDA requirements”?
When life science compliance managers develop training that targets the sales and marketing of life science products, they refer to several regulations which include the Food, Drug, and Cosmetic Act (FDCA), the Anti-Kickback Statute (AKS), the False Claims Act (FCA), the more recently the Sunshine Act. The Food, Drug, and Cosmetic Act Chapter V is part of Title 21 of the United States Code. Part A, Section 501, references the misbranding of drugs and devices. As you review the FDCA, AKS, FCA, Sunshine Act, review recent CIAs, and Department of Justice (DOJ) settlements, you quickly realize that you need a law degree to figure out what the requirements are for your sales and marketing teams. You can also appreciate why compliance attorneys tend to develop lengthy training presentations as they combine the law with your company’s policies and procedures. As an instructional designer, my goal was to define the expected behaviors for sales and marketing professionals in the life sciences industry and develop an instructional strategy to address those behaviors.
In summary, the expectation of the HHS: OIG and FDA, are that life science industries conduct ethical research that results in products that are both effective and safe for patients, with the understanding that no drug or medical device is ever 100% effective or safe. Once the FDA approves a product to enter the market, the expectation is that (a) manufacturers educate healthcare practitioners with truthful and non-misleading information about their products, (b) continue to monitor the effectiveness and safety of the product, and (c) practice fair and ethical sales and marketing practices. Manufacturers need to provide healthcare professionals with truthful scientifically-substantiated information about the product and not use any selling strategy that could be interpreted as buying the physician’s business. Recent cases against pharmaceutical have focused on the latter principle of providing goods or services to influence the writing of prescriptions, which can be interpreted as a bribe or kickback. The challenge of teaching sales and marketing professionals all of these laws, regulations, and policies is that it seems too much to learn and apply while focusing on their task of promoting the companies’ products.
The Workshop Educational Video Series
Life science compliance training professionals need to present industry case studies, the principles of the PhRMA Code, US federal healthcare laws, and their company policies to their sales and marketing teams without putting them to sleep. Sales and marketing professionals are focused on the task of marketing the company's products. It is very difficult to keep the attention of a salesperson on laws and policies that they may perceive as obstacles to their goals. As a compliance training professional, you need to first gain their attention by using stories and visuals that will not only engage but reframe a person’s way of seeing the world. While showing an EE video to a senior-level marketing executive, after uncontrolled laughter at the absurdity of the behaviors of the marketing team in the story, he stopped in his tracks and asked the question, “what does this say about our marketing team?” The story and humor caught his attention and in a split second, he shifted from laughter to a self-reflective type question. In communications and educational research, the technique used in The Workshop video series is referred to as “entertainment-education (EE)". Entertainment-education (EE) is an approach to communicating an educational message through storytelling, acting, and connecting with a reader’s or viewer’s emotions. Laughter is a powerful emotion. Just the right level of tension or stress is also an emotion. In the design of The Workshop educational video series, we set out to develop an educational story with this balance of tension, emotion, humor, and reality. After 6 months of research and an ah-ha moment the morning after a creative design session, I came up with the idea for The Workshop.
Many success stories are preceded by failure. My first EE project was called ThePhaRM. In ThePhaRM, the balance of tension, humor, and reality wasn’t quite right. We tipped the scale a bit too much on the side of sarcastic in-your-face humor that was rejected by the audience. Several salespeople told me that it was offensive to them because it felt like an affront to their profession. It made them look foolish. Sales and marketing people didn’t connect with the characters emotionally. I went back to the drawing board. I conducted about a year of additional research by attending conferences, conducting interviews, reading industry cases and research papers and then started on The Workshop project with the team at The Second City. I applied my research findings to the design of The Workshop. The result was dramatic when compared to the feedback to ThePharm video series. Salespeople came up to me in meetings and told me repeatedly that they couldn’t believe how real it was. They loved the stories and the characters. Some people told me that they were watching the videos at home with their families. This is the type of effect that you want to have with a well-designed entertainment-education program. You want your learners to connect with the story and the characters while causing self-reflection on their past behaviors. The Workshop was designed to teach the principles of compliant promotion of life science products while also causing people to reflect deeply on ethical business decision-making.
To be continued ...