Progress Toward an Ethical Mindset

Everyone agrees that industry must move from rules- to values-based decision-making to ensure compliance with government requirements. For sustainable risk management, Commercial must think about “what’s the right thing to do” when designing initiatives and interacting with external audiences. It’s not enough to check off the certification box that training has been implemented and employees have completed the exercise.

If industry knows where it needs to go, why is it taking so long to get there and what adjustments are needed to bring an ethical values-based framework to compliance training for the field force?

Three Components for Change

According to Michael (Mike) Peterson, Professor and Chair, Department of Behavioral Health and Nutrition, University of Delaware, compliance training must address three components to have a true impact on ethical decision-making:

  1. Cognitive: Considers what employees need to know to remain in compliance.
  2. Emotional: Focuses on how employees feel about what they choose to do, or how they act.
  3. Behavioral: Helps employees act on information in a compliant way.

Before focusing on opportunities to bolster these components, let’s look at how rules-based compliance evolved.

How We Got Here

In 2005, OIG’s Compliance Program Guidance set out requirements for an effective compliance program. Compliance and Legal’s interpretations of the OIG guidance were rule-based.

“The commercial organization was told what to say and what to do, what to leave and what not to leave behind. Sales representatives didn’t have an opportunity or a need to think through what the right or wrong way is to handle a situation, so they didn’t have any practice making value-based decisions,” explains Jim Dawson, formerly Chief Compliance Officer, United Therapeutics Corporation.

Dawson continues, “At the same time, compliance professionals may have lacked a keen understanding of business process and practices, which may be why those in this role did not understand root causes for Commercial’s problems. Ultimately, it was a confluence of two factors driving rules-based decisions.”

Re-evaluating Approaches to Change Behavior

Cognitive: Teaching the “why” behind selling materials

Training companies do an excellent job explaining compliance fundamentals, including, but not limited to marketing practices affected by the PhRMA Code, False Claims Act, Anti-Bribery Act, and Sunshine Act, to name a few. However, do sales representatives know that they can’t make superiority claims based on a sales aid that compares their product’s Mechanism of Action (MOA) with the competitor’s MOA?

When representatives mention a product name in the same communication as its uses, are they providing the HCP with enough risk disclosure? Do they understand that risk disclosure must be integrated and presented with similar prominence to effectiveness claims, and that they cannot separate risk from benefit information?

Sales representatives may not be fully aware of the regulatory compliance requirements affecting the claims they can make utilizing the promotional materials they have been given. Historically, the focus has been on presentation of claims and clinical data support with less focus on regulatory guidance supporting the required presentation of promotion. This cognitive gap can be easily addressed.

“Compliant promotion is a competitive advantage for field forces because it helps build credibility and trust. Balancing the emphasis on the ‘why’ and ‘what’ in promotional claims training generates motivation to ensure sales calls are consistently aligned with approved promotion,” says Lisa Pilla, an industry consultant who has led sales and commercial organizations in Fortune 500 and independent biopharma companies.

Pilla explains that any change in the competitive environment, from new entrants to changes in the competitor’s labeling or formulary coverage/market access relative to the competition, can present challenges to the sales force. These milestones prompt discussion of competitors by HCPs during sales calls and are therefore critical timepoints to train on regulatory requirements and clarify what can and cannot be communicated and why.

Additionally, training on regulatory requirements along with promotional claims in sales materials should occur when companies are embarking on new marketing initiatives, for example, DTC programs, or outreach to patient groups.

Emotional: Engaging the field force with WIFM

According to Peterson, the second component—emotional engagement—is the most important factor because it drives an individual’s motivation to change. He provides this example: Representatives who still believe that Compliance is a watchdog or that the compliance department is suppressing sales may experience a negative emotional impediment which can affect their commitment to doing the right thing.

Using a proprietary mindset assessment tool, Peterson can diagnose and dispute these cognitive distortions by reinforcing the WIFM or “what’s in it for me” to create a positive connection. One solution: Integrate testimonials from commercial advocates who have experienced increased sales or uncovered new pathways for business growth from their compliant behavior into compliance training.

Behavioral: Goal setting and self-monitoring

In some situations, acting ethically will require representatives to share information about side effects, which could lead a physician to prescribe another product for a patient. That’s why it’s important to reinforce and reward non-monetary goals in compliance training, such as enhanced physician loyalty or building the company’s reputation.

“Representatives can’t feel that they are in a lose-lose situation,” Peterson explains. “If building stronger HCP relationships isn’t a goal that’s rewarded, representatives will feel that there is no upside for losing the sale by telling the truth.” In addition to establishing achievable goals, Peterson recommends self-monitoring plans. “These can be as simple as a list of emotional motivators and behaviors that remind the individual how to override making non-compliant decisions.”

Peterson underscores that there are many behavioral change models that need to be considered when creating a new social norm where representatives are not focused on selling a product, but rather on the benefits of selling the truth to help doctors improve patient health. These models look at such factors as vicarious learning, an individual’s sense of “do-ability” and control over their own behavior, as well as how strong their intent is to reinforce the ethical behavior. He concludes, “Changing behavior is highly individual, which is why true ethical decision-making is a complex issue which requires multiple interventions.”

  • Ilyssa Levins

    Ilyssa Levins is President and Founder of Center for Communication Compliance (CCC). Ilyssa helps manufacturers and their promotional agencies save time, money and manage risk, when promoting drugs and devices. She combines her regulatory compliance, marketing communications, and change management expertise to help clients achieve their goals.

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