By the PharmaCertify Team
Originally published in the October issue of RXCompliance Report
Sports metaphors have become clichéd because they are an extremely effective tool for enhancing comprehension. When selling prescription drugs and medical devices, the rules of commercial compliance define the playing field within which all other activity occurs. That is, all marketing and sales activities must take place within an environment that is compliant and aligns with the regulations dictated by federal and state regulators.
This playing field metaphor is quite different from one in which the rules of commercial compliance represent just one of the knowledge bases which must be mastered. That metaphor looks like Figure 1. In this view, training in the rules and regulations of commercial compliance, such as on-label promotion, the Foreign Corrupt Practices Act (FCPA), the Prescription Drug Marketing Act (PDMA), HIPAA, and rules governing meals and speaker programs, is seen as a onetime event. For example, a two-hour live training session with a slide deck, a home-study manual, or an online module, may constitute the whole of training.
Standard view of knowledge bases required for sales and marketing
In actuality, all of the activities and communications that take place in the sales and marketing arena are proscribed by the rules and boundaries of commercial compliance, as shown in Figure 2.
Commercial compliance is the playing field for all activities and knowledge bases
Commercial compliance training should not be a single event, but rather an integrated component in all aspects of a companies day-to-day business. Otherwise, the risk that behavior driven by financial incentive—boosting sales—will take precedence over staying in bounds and strictly following the rules. This may put the whole enterprise at risk.
So what should a commercial compliance training program based on Figure 2 look like? As represented above, it should be ongoing, encompassing all activities in an integrated approach. An initial training event focused on compliance issues, whether live, online, print or a combination of all three, would be the start of a continuous training effort. This training should extend to all activities potentially impacted by commercial compliance concerns.
Changes in regulations, such as the upcoming spend reporting requirements in the Patient Protection and Affordable Care Act, should be reflected in updates to all affected courses and in new training events.