Update Nov Dec 2013 - (Page 13)

Enforcement companies to research, develop, publish, grow, and sell. The Power of Culture There is another pressure that is so overpowering that it can mitigate the potential excesses of drug development and commercialization strategies - corporate culture. It has been said that "culture trumps strategy, every time."1 If a corporate strategy "conflicts with how a group of people already believe, behave or make decisions, it will fail. Conversely, a culturally robust team can turn a so-so strategy into a winner. The 'how' matters in how we get performance."2 A recent survey indicates that, "Promoting a culture of integrity is the top [compliance] program goal."3 "The results are striking; employees in lower integrity cultures are almost nine times [more] likely to observe business misconduct than employees in higher integrity cultures. Additionally, going from an unfavorable perception of culture to the most favorable perception increases the reporting rate to 74.2% from 53%."4 A corporate culture permeated by the importance of regulatory compliance can lead to effective self-enforcement but only if the commitment to compliance is sincere and the ability to enforce is strong. Outsiders' Perception of a "Culture of Compliance" "Culture of compliance" may have become an overused phrase in the pharmaceutical industry to the point of being a cliché. It is unclear from outside the company whether a compliance program is robust, a "paper program," or something in between because employees invariably describe their company as having a "culture of compliance." When the knee-jerk reaction of commentators to a $3 billion dollar fine levied on GlaxoSmithKline is that it amounts to FDLI "the cost of doing business,5" it becomes clear that the credibility of drug companies in claiming a compliant culture is lacking. The outsiders' perception of reality is a cynical one, justified or not. Credibility is a Lynchpin of Compliance Credibility may be seen as the essence of compliance in a relationship-based business such as pharmaceutical development and commercialization. Those relationships with healthcare professionals, payers, regulators, and the public involve promotion, research, publications, educational grants, and peer-to-peer scientific exchange. Defining "compliance" as adherence to FDA regulations is necessary but not sufficient, as the literal meaning of those regulations is not always clear, even when illuminated by agency guidance. Providing advice on how to avoid running afoul of regulations is rarely as straightforward as saying, "You can do this, but you cannot do that." There are the concepts of business risk and compliance risk, and far more often than not, balancing these concepts involves making decisions colored with shades of gray rather than black-and-white clarity. The problem is not necessarily one of intent, although the skeptic may assume that alleged malfeasance is intentional. Rather, the issue is often one of clarity: people often want to do right but simply do not always know the right course when they face countless conversations with different physicians, payers, and regulators in the course of their professional lives. Each conversation is different, and there is some compliance risk any time a company employee engages in a conversation with a customer, for example, because the employee neither knows what the customer is going to say or how he, the employee, is going to respond. Developing Credibility through Communication and Clarity For compliance and regulatory professionals to develop credibility with our business partners, it may help to elevate our conversations with them from a literal to a conceptual level. Elevating the conversation helps to explain the rationale underlying the message we are trying to convey in a clear and simple way. Also, we in turn would want our colleagues to be able to articulate that rationale so that they can develop credibility with the stakeholders with whom they interact. How specifically can we develop credibility with our colleagues and help them build credibility in their relationships with stakeholders? Channel Ronald Reagan's ability to simplify a message. Our companies have an obligation to prioritize patients' health and safety, and it is essential to demonstrate a commitment to that goal. But most employees probably do not know or even want to know regulatory particulars even if their commitment to being compliant is sincere. That is where your role as a conduit of important yet complicated information comes in. And making complicated information easy to understand can be difficult. As Albert Einstein said, "If you can't explain it simply, you don't understand it well enough." Sales representatives and scientists have different backgrounds and skill sets from attorneys and regulatory professionals. Your commercial and medical colleagues are not interested in the text of specific regulations or how fair market value is calculated. They simply want to know what they need to know to perform their jobs the right way. Ensuring that employees understand what you are asking them to do is necessary for them to do it. November/December 2013 Update 13

Table of Contents for the Digital Edition of Update Nov Dec 2013

Update Nov Dec 2013