By Lauren Barnett
Compliance Content Specialist, PharmaCertify

In the world of corporate ethics and compliance there’s a great deal of talk about “tone at the top.” I think most people working in commercial compliance would agree that tone at the top is an essential and foundational component of an ethics and compliance program. Bob Lane, Chairman of John Deere, recently said, “The unmistakable linking of words and deeds in all aspects of business is one of the best ways to assure that the ethical tone is matched with actions.”[1]

Nothing does more to silence the tone at the top than failure to match words and deeds.  The news is littered with tales of what happens when the actions of those at the top do not match their words. In a time when the government has made good on its promise of holding individuals liable for violative behavior in a company, doesn’t the tone at the top need to be continuously reviewed and modified?

Considering that as individuals, we can only truly control our own behavior, those at the top can at least enhance their tone by implementing informal ethics and compliance training through their daily interactions. One effective first step is to take the time to talk with colleagues about one’s own ethical dilemmas, whether the response to those dilemmas proved to be the right decision and what was learned in the process.

Something as simple as a note to the compliance officer that can be shared, or a picture on the company intranet showing timely completion of the required annual compliance training is another informal way to communicate commitment to supporting an ethical culture. By enhancing how they model their commitment to ethical behavior, executive management shows employees that setting the tone at the top isn’t just “corporate speak,” but a viable dedication to changing behavior, as an executive’s direct reports model that same commitment to their own direct reports and throughout the company.

Encouraging this more open and interactive dialogue about ethics and compliance from the top can certainly get the ball rolling in the on-going process of creating a culture in which the “right way” to do business is never in doubt.

1 Lane, Bob (2009). The Role of Tone at the Top.  Retrieved from: http://ethisphere.com/the-role-of-tone-from-the-top/

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.

Figure 1

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.

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.

By Lauren Barnett
Compliance Content Specialist, PharmaCertify

For a few years now, individuals from the Office of Inspector General and Department of Justice have been warning the pharmaceutical industry about a movement toward individual accountability in regard to fraud and abuse of healthcare laws. It seems we are starting to see the promise become a reality. Recently, a pharmaceutical executive was indicted on obstruction of an official proceeding, making false statements, and concealing and falsifying documents in relation to a FDA inquiry regarding off-label promotion of one of the company’s drugs.  In the DOJ press release an FBI agent was quoted as saying, “This indictment shows that we will investigate those responsible for illegal activities done on a company’s behalf. When individual employees are identified they will be held accountable for their illegal activity.”

As a compliance professional, what is the teachable moment that can be taken from the news of this indictment?  While  there’s always that “orange jumpsuit” conversation, that is probably not the most constructive approach. There is certainly room to discuss that off-label promotion is still a very hot issue, or a host of issues surrounding speaker programs and advisory boards. These are all great discussion topics, however at the heart of this indictment lays an issue that applies not only to those in sales and marketing, but every employee within the company and one that echoes the sentiments of the government; personal responsibility.

Compliance does not lie in the hands of a select group of individuals with “compliance” in their title. It lies in the hands of each employee. Employees must make sure they  understand the laws, policies and ethical standards of the company, and ask questions when they don’t understand. No policy or procedure can address every situation an employee may encounter in day to day activities, so it is the responsibility of the employee to ask questions when the policies in place just don’t seem to fit a particular situation. It is also  the responsibility of all employees to hold their colleagues to these standards.

This indictment presents an opportunity for compliance officers and trainers to discuss what has been alleged and the impact beyond the hundred million dollar fines and CIAs. Compliance is more than a yearly check the box exercise; it is about a way of conducting business that benefits both the company and the patient. It’s time for a new conversation.

By Sean Murphy
Senior Account Manager, PharmaCertify

Whether delivered from government regulators or pharmaceutical industry leaders, the take away messages from PCF’s Eleventh Annual Pharmaceutical Regulatory and Compliance Congress could be whittled down to three key points – personal accountability for executives is coming, it’s time to integrate commercial compliance awareness and training into everyday business activities and global transparency management, and, relevance to the FCPA needs to be a focus for any company doing business worldwide.

The preconference sessions offered a series of important background presentations that set the stage for three days of lively conversation and interaction.  Sessions included an overview presentation conference, with a review of the laws, regulations and federal sentencing guidelines, by Wendy Goldstein of the firm Epstein, Becker & Green PC.  Kelly Freeman, Ethics and Compliance officer, Eli Lilly and Company, offered tips for implementing the seven elements of a compliance program, as suggested by OIG policy.  Slide decks for both presentations can be found on the conference website at www.pharmacongress.com.

Day 1 of the conference, started with an audience in rapt attention, as Mary Riordan, Senior Counsel, Office of Counsel to the Inspector General, presented a comprehensive update of recent settlements and the OIG’s focus going forward.  Personal responsibility and convictions for pharmaceutical executives is on the horizon and Ms. Riordan made no secret of the potential for personal exclusion to government reimbursement programs being part of those convictions. She also reviewed the groundbreaking Synthes/Norian case in which settlement terms included the requirement for Synthes to divest itself of Norian. As part of the settlement, three executives of Norian pleaded guilty to misdemeanor violations of the FDCA and are awaiting sentencing.  In addition to her review of current pharmaceutical settlements, Ms. Riordan emphasized that the trend toward more cases focused on the medical device industry will continue.

Day 1 concluded with a strong panel session of pharmaceutical industry compliance leaders who discussed their companies’ approach to integrating compliance into the business units, and the need for combining a rules-based approach versus a values-based approach to the training.  Caroline West, of Shire Pharmaceuticals told the audience that taking training to the next level has been a priority. A “check the box” mentality is no longer enough. Michael Shaw of GlaxoSmithKline explained that the compliance messages at his company are no longer being driven by the compliance department but by the individual business leaders.   Douglas Lankler pointed out that Pfizer has even taken the steps to brand their compliance efforts with the moniker, “It’s Mine,” to remind all employees of the on-going need to take ownership of the efforts.

Considering the questions around inclusion of elements of the Sunshine Act in the recent Healthcare Reform Bill, the opening presentation for day 2 by Maggie Feltz of Purdue Pharma was well timed.  Her slides can also be found on the conference website and offer a solid summary of the state of federal transparency. During a follow up panel session on the Federal Sunshine Act and State Laws, Rore Middleton of Purdue reminded attendees of the need for continuous training by explaining “we pull reps in often for the training and they understand that they are the first line of ownership.”   The bulk of the second day was structured so attendees could chose one of many separate session tracks, depending on their interests, including auditing and monitoring, internal and external investigations, research and development and the FCPA. Prior to a closing plenary session that offered compliance reports from different parts of the world, Ted Acosta, principal at Ernst & Young LLP offered the sobering statistic that the “typical pharmaceutical company has approximately 25 million global interactions per year” and therefore that many chances for a violation of the FCPA.

Day 3 of the conference began with those in attendance being asked what they would like to hear discussed by that day’s panel former regulators.  Fittingly, the overwhelming choice was “How to Avoid Being the Subject of an Investigation.”  Brent Saunders, Chief Executive Officer of Baush + Lomb, and a former compliance officer, delivered a closing keynote on the compliance perspective from private equity and the C-suite.  An overarching point to Mr. Saunders’ presentation was that “the Chief Compliance Officer needs to be more than just a partner to business leaders, that person should be one of the business leaders,” echoing the message presented on Day 1 by Michael Shaw of GSK and others throughout the entire conference.

For a review of each days agenda for the Eleventh Annual Pharmaceutical Regulatory and Compliance Congress, and access to many of the slide presentations, visit, www.pharmacongress.com.

By Lauren Barnett
Compliance Content Specialist, PharmaCertify

Leading a live compliance training session is always a challenge. More often than not, I’m the only geek in the room that finds the minutia of the Anti-Kickback Statute and False Claims Act fascinating. So, I’ve learned that these sessions need to be engaging (good luck right) and leave the learner feeling confident they won’t go to jail tomorrow because they said hello to a physician that day. I was growing tired of all my other interactive “tricks,” and the sound of my own voice repeating  the same information. A change was definitely in order.

Then it came to me… a simple little game from childhood that could be adapted in the classroom – Bingo! Yes, Compliance Bingo. I set about creating my game. Instead of a B4 square, my game would have answers to questions the learners should know. Eureka! The day came for the class, and off I went, excited to try this out with a group of seasoned and skeptical sales representatives.

With official Bingo card dobbers in tow, I handed out the cards and explained the game.  The snickers around the room were not a good sign, but I pushed on. Within the first few calls, the snickers stopped and people were hunched over their cards, searching for answers. You could hear the whispers of discussion trying to figure out what they were supposed to know already. The first person shouted out “Bingo!” Shock of all shocks… they didn’t have it, he had missed a question! And he wasn’t the only one. As we played on, more people called out “Bingo,” only to find out they had answered a question wrong. We played for most of the class, and at the end, we engaged in an educational discussion about the questions that were missed. As I packed up my supplies, I couldn’t help but reflect on how that session had been one of the best tools for assessing just where the training was missing the mark and where people were really “getting it.”

But beyond learning valuable information about where the gaps were in the existing training, I learned just how impactful a game could be, even for compliance training.  Intellectually, I knew that games had the potential to bring excitement to a class and engage people in the subject matter, but I had veered away from games in practice. After all, we get precious little time in front of reps. Did I really want to use that time on a game, and risk people getting caught up in the fun and lose the importance of message? After that class, that answer is a resounding “Yes!”  What I intellectually thought to be true about bringing games in to the learning environment did not diminish the weight of the message.

Later that day, a member of the Sales Training team caught me in the hall. “That was the best Compliance training session I’ve ever attended,” he told me. I thanked him and thought to myself, “Me, too.”

By Peter Sandford
Executive Vice President, NXLevel Solutions/PharmaCertify

So what does Swedish furniture maker Ikea and most compliance training have in common? I think the question should be more like what should they not have in common. The answer to the second statement is; the learning experience.

If you have ever started the process of building a piece of furniture from Ikea with a heightened level of excitement, only to have that excitement turn into frustration as you attempt to follow the supplied directions, you understand the mixed emotions that come along with a poorly designed learning experience. You’re excited to have something to show for your efforts, but it’s not an exercise you ever want to go through again.

The same can be said about standard healthcare compliance training. At least with the Ikea furniture, you can reference the picture in the catalog or online during the assembly process to see what will be the fruits of your labor. The carrot if you will. The same cannot be said about compliance training. Most learners don’t necessarily look forward to taking the training, let alone fully recognize how it can actually impact their job, and their company, in a positive way. In other words, they can’t see themselves sitting in that cool chair or using that new desk.

Compliance training does not and should not have to be an uninteresting exercise. Learners should not go through the training thinking “Why do I need this” or “I don’t get how this is going to help me.” Just as you can always look at the picture during the Ikea assembly exercise for motivation, learners should have a clear and positive picture of why compliance training is a critical part of their job. They need to “see” why.

Clearly stated learning objectives should be more than “To comply with federal, state and company regulations.” Your learners know this. They should clearly state how students will learn to understand the varied regulations, know how to apply those regulations to their day-to-day efforts, and comprehend how understanding this complex regulatory environment that they work in will help protect them, protect their company, and make for a more productive and positive work experience.

However, just as Ikea believes that those crazy pictures with a few words are enough to easily get you through the assembly process, learning objectives that users can relate to won’t mean a thing if the content and learning experience doesn’t back up those objectives and provide the learner with “real-world” compliance scenarios. Don’t just have learners read the regulations and policies and then expect them to answer some questions. Use the available tools present with today’s technology to bring that content to life and put it in context for the learner.

Don’t make the modules any longer than they need to be. Remember that frustrating feeling during the furniture assembly when you realized that you’re on step seven of a twenty-one step process? If the content requires a longer learning experience or seat time, break it up into multiple modules. You don’t need to assemble the entire dining room set in one long session. And finally, use the final assessment as a way to reinforce the real-world nature of the content, not just a way to get them to show a passing score for your records.

When you’re finally finished with the Ikea assembly process you should have something to show for it, and hopefully it even looks like the picture! The same holds true with your training, after completing a compliance program, learners should be able to “see” how the training looks in their real world. Having this vision and focus will  lead to a more productive, confident, and compliant sales experience.