Open Payments

Move Beyond the Basics to Make Compliance Training Stick

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We’ve come a long way in life sciences compliance training in a relatively short time. Fifteen years ago, the common approach to compliance training often involved lawyers from the legal department, using PowerPoint slide decks to train large groups, once a year at POA sessions. Somewhere along the way, the industry recognized the importance of instructional design, and the power of technology, as the focus shifted to eLearning and the on-going search for ways to use it in an engaging and creative manner. That pursuit continues.

Instructionally-sound, creatively-scripted eLearning still represents an effective method for training large groups across a company, but to truly reduce risk, micro-learning concepts need to be strategically integrated to your curriculum. More targeted training, focused on specific subjects, and smaller audiences, is key. Let’s use anticorruption training as an example.

Anti-bribery legislation is on the rise around the world, and the increasing risks associated with the growing number of laws requires a comprehensive approach to your anti-bribery/anticorruption (ABAC) training. Core ABAC training, by nature, needs to address an expansive topic list, and it needs to be targeted to audiences as diverse as sales and marketing; medical affairs; regulatory; logistics; and manufacturing. Once that core training is launched though, the audiences that represent the highest risk (i.e., sales and marketing), and the topics that present the greatest risks to those audiences, (e.g., third-party red flags) need to be identified. As one example, deploying a smaller module on “recognizing and reducing third-party red flags,” to the sales and marketing audience after the broader ABAC module is completed, reduces risk for the one audience that has direct contact with third-party intermediaries.

Micro-learning doesn’t have to end with mini-modules. Employees are seeking information and training differently than they did back in those PowerPoint-driven years. Tools such as infographics and scenario-based video sequences offer more opportunity to make the focused learning stick, especially when spaced appropriately across a learner’s timeline and blended with other learning components. In addition, reinforcement doesn’t end with training. Apps offer an ideal method for delivering “just-in-time” reference content where the employees need it most – in the field and at their fingertips. In this case, offering access to a list of red flags, and tips for how to identify them, would drive down the risk for that sales and marketing audience.

The PharmaCertify team will be exhibiting at the 14th Annual Pharmaceutical Compliance Congress in Washington April 26-28. If you’re attending, stop by Booth 10 (it’s back there where CBI keeps all the good food!) to share your ideas for reinforcing compliance learning in your organization. After all, we’re compliance learning geeks – we want to hear them! And don’t miss Dan O’Connor, Senior Vice President for PharmaCertify™ at NXLevel Solutions, as he and his co-presenters offer a conference prelude session on healthcare compliance and policy applications.

See you in Washington!

Sean Murphy, Product and Marketing Manager

The Forgetting Curve and Compliance Training

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What exactly does a 167-year-old German scientist have to do with your compliance training? As a chief compliance officer, or training manager, the answer may keep you up at night – especially if you haven’t integrated micro-learning elements continuously into your company’s compliance learning curriculum.

Hermann Ebbinghaus was a German psychologist who is credited with theorizing fundamentals of human learning, including the learning curve, the spacing effect, and the forgetting curve. The Ebbinghaus Forgetting Curve essentially states that what humans remember after a learning event drops steeply soon after completion of that event. His research shows that memory loss continues to increase until it finally flattens around 30-days post event.

 

Steven Just, Ed.D., Chief Learning Officer at Intela Learning, a developer of continuous learning platforms, writes, “What gets stored in our long-term memories is subject to decay (i.e. forgetting)… deep learning occurs when memories are stored in long-term memory and stabilized. This is called memory consolidation.”

Fortunately for those of us seeking to reduce compliance risks across a company, spacing follow up micro-learning components, in smaller chunks, across a learner’s timeline helps flatten that forgetting curve and increase retention. As Dr. Just writes, “Retrieve the memory from long-term memory, bring it into working memory, process it, and then re-store (re-encode) it in long-term memory.”

Micro-learning Tools

Short “sprints” of learning deployed in follow up to foundational compliance training provides that opportunity for the concepts to be “re-stored” in the learner’s long-term memory. Micro-learning can include brief mini modules focused on one topic that you’ve identified as needing reinforcement. If gifts and meals are a high risk for your HCP-facing employees, a scenario-based mini module built around a common situation they face in the field, deployed soon after the comprehensive training, is one method for alleviating their concerns and reinforcing the appropriate behaviors. Mini modules aren’t the only effective tools for flattening the curve though. Short learning nuggets like quizzes and gaming, strategically deployed over time serve to heighten retention as well. As another option, sprint activities and scenario-based mysteries can be delivered in a competitive workshop format to reinforce participants’ understanding of policies and principles. (We call it the Compliance Reality Challenge).

Code of Conduct

Considering the range of topics covered in a typical code of conduct, from workplace violence; to harassment; and gifts and hospitality, a more creative and engaging approach to reinforcing the initial code training is not only a good idea, it’s crucial to improving the learning. One approach we’ve deployed to successful reviews is what we’ve titled Know the Code. Working with the client, we target specific topics within the broader code of conduct to create a “streaming” series, with each 7-minute “episode” built around those topics. Each animated scene in a scenario lasts approximately one minute. A narrator character tells the story and when necessary, directs the learner to take part in on-screen activities, with individual character voices employed to bring life and realism to the scenarios. The episodes are strategically released across a timeframe designed to once again, “re-store the concepts originally covered in the core module into the learners’ long-term memories.”

Keep it Continuous

The bottom line: to make compliance training as effective as possible in terms of reducing risk across the company, the learning nuggets you continuously rollout after the initial event (eLearning module, instructor-led training, etc.) are as important as the initial event itself. PharmaCertify offers the reinforcement tools, instructional expertise and an exciting new system that uses the most widely-accepted algorithm for creating and delivering post-training learning sprints to accomplish that goal. If you’re attending the 14th Annual Pharmaceutical Compliance Congress April 26-28, stop by Booth 10 to see demos of the products and platform, and ask how we can help reduce risk and strengthen the compliance culture in your company.

Thanks for reading and we’ll see you in Washington!

Sean Murphy, Product and Marketing Manager, PharmaCertify™

Compliance News in Review, January 27, 2017

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The Serious Fraud Office leads the charge on Rolls-Royce’s multi-jurisdictional bribery settlement; the FDA releases new draft guidance; and a new transparency law is on the way in Maine.

While most obscure, strange, and funny “holidays” may be dismissed as whimsy, and fodder for creative water cooler conversations, Chocolate Cake Day is one that we here at the News in Review celebrate with vigor and enthusiasm. From Devil’s Food to Black Forest, we look forward to marking the occasion with more than one variation on theme. In fact, why not just make a weekend of it? Meanwhile, if a day dedicated to the splendors of chocolate cake isn’t sweet enough for you, we offer a delectable morsel of a different type, with this edition of the Compliance News in Review.

Rolls-Royce is getting its just desserts on three continents. The company recently entered into a $800 million multi-jurisdictional settlement with the UK’s Serious Fraud Office (SFO), the Department of Justice (DOJ) in the U.S. and Brazil’s Ministério Público Federal, to resolve charges it paid bribes to foreign officials in Eastern Europe, the Middle East, South America and Asia. In a twist on the usual tale, the SFO, not the DOJ was the agency spearheading the investigation. In addition to the financial penalties paid to each country, Rolls-Royce entered into deferred prosecution agreements with the U.K. and US governments, and a leniency agreement with Brazil.

The FDA is working on a new recipe for sharing healthcare economic information (HCEI). The agency released draft guidance for the sharing of HCEI with payors, formulary committees and similar entities. The guidance includes questions and answers about sharing HCEI related to investigational products with payors. The comment period for the draft guidance began January 17 and will remain open for 90 days.

On the state level, a legislator in Maine read a newspaper report about the increase in promotional spending by companies that manufacture opiods, and decided to introduce a law intended to curtail gifts from the industry to physicians. The language in the bill is based on the Minnesota gift prohibition law

Anticorruption efforts around the world are moving full steam ahead in 2017 and the fact that the SFO is spearheading investigational efforts presents a new twist. We don’t know yet if this is the start of a new trend, but we do know the SFO has the means to investigate and resolve large cases like the one with Rolls-Royce. Since the passage of the UK Bribery Act in 2011, the news around potential investigations has been quiet, but that is clearly changing. Like the U.S. Foreign Corrupt Practices Act, the UK Bribery Act has a wide reach.

Now is the time to review the training components of your anticorruption program to ensure employees, vendors and other third parties are being trained regularly about bribery laws and your company’s policies. Is that training engaging and based on real-world scenarios? Is deployment spaced over time to maximize effectiveness and retention? Have you mixed in smaller, more-focused micro-learning to reinforce topics like “identifying red flags?” Taking proactive steps now will strengthen help reduce risk and strengthen your culture around the globe for years to come.

With that, we put the wraps on this tasty edition of the Compliance News in Review. Until next time, we say, “let them (and us) eat cake!”

Thanks for reading and have a great weekend!

Compliance News in “Preview”

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As we wistfully wish 2016 a fond farewell, we welcome 2017 and wonder what compliance surprises, developments, and news the year might hold. What will be the hot topics debated around the water cooler in your office? The team at the Compliance News in Review has dusted off its crystal ball once again and we offer a few suggestions on what we see as the hot topics for 2017.

Drug Pricing Transparency

Drug pricing was at the top of the list in 2016. CEOs were brought before Congressional panels to explain exorbitant price hikes, and in several states, laws were proposed that will companies to disclose factors related to drug pricing for certain drugs. Vermont was the only state to pass such legislation, but California has reintroduced the bill for this session. The federal government also got in on the act with a bipartisan bill introduced in the Senate. While some of the fervor has quieted, we don’t think we’ve heard the last of pricing transparency. The passage of Vermont’s law could be the catalyst other states need to get their own laws passed.

Off-label Guidance/Revised Regulations

We don’t expect to see new guidance or regulations in 2017, but the FDA did at least start a conversation with the industry in 2016. A two-day meeting with stakeholders in November resulted in a list of diverse statements and opinions from companies, the medical community, and patient groups. The meeting with stakeholders was a step in the right direction, but a few high-profile cases (Caronia, Amarin, and Pacira) that resulted in wins for the industry, only led to more confusion and questions. We are cautiously optimistic that the FDA will at least continue the conversation and somewhat clarify the regulations.

Warning Letters and Notice of Violation Letters

The FDA’s Office of Prescription Drug Promotion (OPDP) wasn’t very active in 2016…until December, that is. At the end of the year, the agency made up for lost time by sending six letters for non-compliance with drug promotion regulations, signaling (in our humble opinion) a more aggressive approach in 2017. Most of the letters that were sent in December were related to the use of digital media.

Bribery and Corruption Enforcement

In 2016, several companies settled with the Department of Justice over Foreign Corrupt Practices Act (FCPA) violations. Most notable was a $500 million plus settlement with Teva that occurred near the end of the year. We expect to see more settlements this year, with half a dozen life sciences companies already under investigation for FCPA violations, according to the most recent Corporate Investigations List on the FCPA Blog. One wonders if the Serious Fraud Office (SFO) will join the trend as well and pursue more UK Bribery Act cases now that the agency has dipped its feet into the pool of U.S.-style Deferred Prosecution Agreements. We wouldn’t be surprised to see SFO dive right into the deep end.

The 2017 year in life sciences compliance looks to be an interesting one, and we’ll be tracking the news and headlines through our Compliance News in Review updates. Don’t forget to “follow” our blog so you don’t miss any news or our tips and best practices for building and deploying the compliance training you need to reduce risk and strengthen your compliance culture.

Thanks for reading and best wishes for a compliant and successful 2017!

Compliance News in Review: the 2016 Year-End Summary

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Here we are again. Another 584 million-mile (940 million km for our metric friends) trip around the sun is nearly complete. It seems like just yesterday we were celebrating the beginning of 2016 and now we’re picking out our favorite brand of champagne to celebrate its end. Before we break out the noisemakers and party favors, let’s take one last nostalgic look back at some of the life sciences compliance-related developments of 2016.

A new milestone was reached regarding HCP spend disclosure. The first disclosure reports under the EFPIA Disclosure Code were released in 2016. Gaining disclosure authorization from individual HCPs proved to be a challenge for the industry and the numbers of doctors who granted authorization ranged widely between countries. According to Britain’s pharmaceutical trade association, ABPI, 70% of their HCPs granted authorization and in Ireland, just over half of HCPs did so. In other transparency developments, ten of Canada’s top drug firms announced plans to voluntarily disclose aggregate physician and healthcare organization payment data. The movement was started by GSK Canada, and other multinational firms including Abbvie, Purdue, BMS, and Lilly followed.

Drug pricing was a big story in 2016. Former CEOs from Turing and Valeant were called to testify before Congress about drug price hikes, and Mylan’s CEO was called to testify over dramatic increases in the cost of an EpiPen. Laws that would require drug companies to disclose information about their pricing decisions were proposed in several states, and a bill was introduced at the federal level with similar requirements. Even with those high profile stories making headlines, only one pricing disclosure law successfully passed this year – Vermont. That law requires a select group of manufacturers to provide information about the factors related to price increases.

A handful of former Insys employees had an eventful year. A former sales representative entered a guilty plea to charges of fraud, and a district sales manager and a several of top executives were all arrested on charges they paid kickbacks to doctors. The drug at the center of the charges is the opioid painkiller, fentanyl. Prosecutors and enforcement agencies claim the individuals offered a variety of kickbacks to doctors to increase prescriptions and encouraged them to prescribe it for unapproved uses.

2016 was an active year for settlements related to bribery cases. GSK, AstraZeneca, SciClone, and Novartis all entered into settlements with the SEC over activities conducted by subsidiaries in China. Orthofix and Teva both set aside cash in anticipation of resolving the FCPA-related charges. Olympus entered into a $22.8 million settlement with the DOJ to resolve charges that a subsidiary covering Latin America paid bribes to healthcare professionals working in government facilities in order to increase sales of product.

We saw a couple of legal “victories” for the industry in the debate over sharing truthful off-label information. In the Amarin case, the FDA decided not to appeal a judge’s decision that allowed the company to share truthful off-label information about its fish oil product. In addition, in proposed jury instructions for a medical device case, the DOJ indicated that it is “not a crime for a device company or its representatives to give doctors wholly truthful and non-misleading information about the unapproved use of a device.”

With a string of legal decisions favoring the industry, the FDA held a public forum in November concerning the ability of drug and device makers to share off-label information. The primary topic was whether the agency needs to revise its regulations considering recent legal decisions and the forum was attended by various stakeholders representing both sides of the argument.

With that, we complete our look back at 2016 and the stories that made headlines in the world of life science compliance. It was an eventful year, and everyone at the Compliance News in Review is excited to see what the new year holds. Thanks for joining us throughout the year and best wishes for a happy, healthy, and compliant 2017!

Notes and News from the Seventeenth Annual Pharmaceutical and Medical Device Compliance Congress

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If the overriding theme of the Seventeenth Pharmaceutical and Medical Device Compliance Congress could be summed up in three phrases, they might be “partnering with the businesses,” “a seat at the table,” and “a principles-based approach to compliance.” On that last one – note the change from “values-based approach” to “principles-based approach.”

Watching recent conferences (and the industry in general) evolve to the point where these themes are at the forefront is refreshing and encouraging. As someone who has worked in life sciences compliance training for ten years, I’ve looked forward to the shift to an all-inclusive approach that considers all ideas and voices in the organization, and ultimately leads to the creation of more valuable and engaging compliance training. Below are a few of my observations and highlights from this year’s conference. The conference organizers offer the opportunity to purchase an archive of individual sessions or the full conference at www.pharmacongress.com. You can preview video clips of those sessions at www.pharmacongress.com/post-con-individual.html.

CCO Roundtable

The Chief Compliance Officer Roundtable on Day 1 featured industry leaders sharing lessons on building and executing a modern and effective compliance program. The panel included representatives from both the pharmaceutical and medical device industries and the conversation focused on two concepts: the practice of thinking from a perspective of risk (the “gestalt of risk,” as one panelist defined it), and the need to focus on what is meaningful to the business when developing and executing a compliance example. One speaker used the example of monitoring sample dates, and how that practice is not necessarily worthwhile to the business. That same panelist emphasized the need for hiring individuals with business experience when staffing compliance positions. Another looked at compliance training as what employees “should stop doing based on prioritized risk.”

Finally, one panelist stressed “prevention” over “detection” and how his staff uses data analytics to help identify problems based on the area of risk. “Defining guardrails, and risk tolerance, is necessary to get out in front of the issues,” he said.

FCPA Enforcement

During the FCPA Enforcement Panel, Joseph Beemsterboer, JD of the Department of Justice, Terry Price, JD of the SEC, and Gejaa Gobena, JD, of Hogan Lovells, discussed the growing number of cases related to the Foreign Corrupt Practices Act. To this point in Fiscal 2016, 24 FCPA cases have been filed, 6 of them against pharmaceutical companies. 85-90% of the 24 cases were related to conduct in China. Pharmaceutical and medical device industries represent such a significant portion of these cases because large numbers of their employees must interact with foreign officials, according to one of the presenters.

Anti-bribery

Day 2 opened with a much-anticipated session titled Behind the Bribe: Multiple Real-World Perspectives on How Foreign Bribery Occurs, Is Investigated, and Could Be Prevented. Regulators emphasized that anti-bribery remains an area of focus, “we are still seeing the same behaviors, and issues with gifts, travel, and entertainment,” according to one panelist. The FBI representative made it clear that the Agency is “committed to going after global bribery” and the “storm that is coming” will focus on the prosecution of individuals. “Culture is critical,” he said, “just publishing a video from the CEO doesn’t cut it anymore.”

The panel included former executive, Richard Bistrong, who spent time in prison for conspiring to bribe officials to win contracts from the United Nations, and spent 2.5 years as a government witness. Mr. Bistrong stressed the need for diligence as foreign cultures can be misleading. Distributors will often sign FCPA documents, then do something else in the practice. “Don’t let get the business done, drown out how to get the business done,” was one of his key points.

First Amendment Update

During the Truthful and Non-Misleading Communications and Recent First Amendment Cases session, a panel of industry attorneys discussed and debated the ambiguity regarding off-label promotion in FDA policy. After revealing the reasoning behind the FDA’s policy (patient safety and advancement of science), a lively discussion led to speculation that the Agency’s recent public hearing and announcement in the Federal Register signals gridlock and tension among leadership. This lack of direction is what led companies such as Amarin and Pacira to believe they needed to litigate their cases, according to one attorney. The session closed with the moderator asking each panelist if he or she thought the FDA would publish any clear guidance in the next year. The responses ranged from “I just don’t know,” to “highly unlikely,” to “no, they’re not.” Don’t expect clarification anytime soon folks.

Managed Markets

The Compliance Considerations for the Managed Markets Business opened with panelists first defining their definition of managed markets and how it differed for each of their companies. The bottom line was that no matter the particulars, it is defined as the functions responsible for “ensuring patients have access to the therapies the physicians write.” One industry representative said her company defines healthcare professionals to include anyone paying for the products, and another included anyone who can influence prescribing decisions – making compliance policies and the regulations pertinent to the managed markets business.

The expanded movement to the use of specialty pharmacies creates more risk, according to the panel, and companies are thinking about those issues in more detail after Novartis’ Corporate Integrity Agreement was made public. Pharmacy Benefit Managers (PBMs), Patient Assistant Programs (PAPs) and Reimbursement HUBs were covered as well, with the panelists stressing that government is starting to examine the relationships established through these entities, and companies need to be aware that laws never meant for managed markets are now being applied to that sector of the industry. As an example, one panelist mentioned, “the data that goes back and forth with charities is a risk area, and measures need to be put in place to ensure it is not used inappropriately by anyone involved with the data.” The session ended with a compelling question from the audience, “how do you ensure copay cards aren’t used for off-label purposes?” The answer came down to extensive monitoring to make sure that anyone who was supposed to be excluded was indeed excluded.

Compliance Training

As the compliance training division of NXLevel Solutions, the PharmaCertify™ team is always eager to attend sessions such as this conference’s What’s New for Training Programs. Since our mission is to help life sciences companies strengthen their compliance cultures and reduce risk, we are always encouraged to hear pharmaceutical and medical device professionals espousing techniques that support that goal. This session was no exception. While each company varied in the particular details, the panelists’ remarks made it clear that a true movement toward a blended approach to compliance, spread across a learner’s timeline, is growing. As one professional described it, “training to the right people, with the right content, the right amount of times.”

While panelists varied on the degree of live training over computer-based training, most agreed that the use of small vignettes, or small “bursts of information,” as one described them, are critical. The live training options included a Family Feud type game rolled out on a regular basis to streaming scenarios. The millennial generation was referenced, and the need for mentoring programs and live training that makes millennials’ transition into the industry a more compliant one.

Training content was a focal point, with one panelist stating “you have to make the content relevant, so people can do their jobs,” as he stressed the need to survey the learners on what else they actually want to learn about, along with questions about whether or not they feel more knowledgeable and if they have the support of their managers.

And let’s not forget about culture and tone of the organization – at the top, middle, and bottom. For example, training needs to emphasize that employees should feel comfortable reporting violations and asking questions.

The PharmaCertify™ compliance training professionals and subject matter experts are always anxious to discuss your compliance training curriculum and plans. To discover how we can help evolve your approach to training, contact Dan O’Connor at doconnor@nxlevelsolutions.com or visit http://www.pharmacertify.com/ to learn more about our products and services.

Compliance 2.0

It’s time for “partnering with the business” and “a seat at the table!” During the Compliance 2.0: Shared Ownership of Effective Compliance Across Business Functions presentation, six panelists (representatives from compliance and business) detailed case studies on how their companies made compliance concepts and programs more concrete and effective. Throughout each example, the importance of bringing the business into the planning from the start was stressed. One team who used the development of a new monitoring tool as their example said, “you have to know and understand the business in order to build a tool that meets their needs as well as your needs.”

One particularly interesting panelist was recently added to his company’s compliance team from the field, as part of the organization’s efforts to foster a strategic relationship between the business and compliance. He represented a compelling example of how that type of program is an opportunity to “infuse ethics and compliance into the company when the business pulls him back,” as he effectively put it. As another eloquently stated, “we have to raise our business partner’s compliance IQ and we can’t do that by ourselves.”

“Access to leadership” was referenced as a key component of Compliance 2.0, as more than one panelist discussed the need for those involved to feel comfortable questioning everything from leadership as the initiatives got started.

Beyond Transparency

My final breakout session was Beyond Transparency: HCP Interaction Risk Management. The session was centered on the use of data and how the transparency data can be used to track issues, then leveraging the auditing results to enhance policies and create more training. One panelist addressed it succinctly when he said, “our goal is to get to the point to where we use data to identify issues faster.” Another used the example of speaker programs and how the data could be used to raise questions about the number of times an individual HCP attended a speaker program, and raise the question of whether that was a concern.

The audience was reminded that “transparency isn’t just TOV data, it refers to sample data as well, and there is a need to overlay sample data with TOV data to reveal more than occasional interactions with one HCP.”

With representatives from both large and small companies on the panel, much of the discussion centered on the tools needed to keep the data organized and up-to-date. One panelist summarized it nicely, “when you do your hiring, make sure you find a person with excellent Microsoft Excel skills.”

The Evolution of Compliance Programs

The first presentation during the closing plenary session, Driving the Evolution of Compliance Programs into Systems Supporting Business Integrity, covered the oft-referenced theme of a “principles-based approach to compliance.” Representatives from three different companies touted the benefits of moving away from a “rules-based approach.”

As a foundation, in a principles-based system, decisions are not based on policy, but more on how individuals think and make decisions. “They need to be given the skills to make decisions,” according to one Vice President of Compliance, and “they need to be empowered to make those decisions and it’s a cultural shift for all stakeholders.” This is approach requires “a high level of trust and respect by leadership for the rank and file,” one panelist noted; and, he pointed out, writing shorter and more concise policies associated with such an approach takes discipline and time – quoting Winston Churchill, he referenced, “I would have written a much shorter speech if I had the time.”

The shift isn’t an easy one and the panelists stressed the need to “get leadership’s buy-in and help them see that a rules-based policy was holding the company back and the new policy will help patients, caregivers, and shareholders.” When an audience member asked “what kind of practical training would you offer to support such a shift,” the panel responded with “go back to the guiding principles of honor, trust, and integrity.”

Summary

While we weren’t able to attend all the sessions at the Seventeenth Annual Pharmaceutical and Medical Device Compliance Congress, we couldn’t help but be impressed with the level of content the conference provided to an audience hungry for any best practices and advice they could garner from their colleagues and subject matter experts. From a vendor standpoint, the foot traffic on the exhibit floor was steady and we appreciated the unique opportunity to engage current and prospective clients in meaningful conversation about their compliance programs and how we can help strengthen their compliance culture and reduce risk.

I welcome your thoughts and feedback. Please contact me at smurphy@nxlevelsolutions.com.

Thanks for reading and stay compliant!

Sean Murphy, Product and Marketing Manager, PharmaCertify™ by NXLevel Solutions

Compliance News in Review, October 14, 2016

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Ghouls, goblins and ghosts galore…the haunting season is here! Enjoy it while you can, before you know it, reindeer, snowmen, and gingerbread men will be scattered across the landscapes. (Poor Thanksgiving…it gets no respect!) No tricks from us though, just treats. And by treats we mean delicious bites of news! So before you head out to wait for the Great Pumpkin, join us for this not-so-scary edition of the Compliance News in Review.

The FDA has carved out time for a public hearing on November 9th and 10th to discuss the subject of communicating off-label uses of drugs and devices. The agency hopes to hear from a variety of stakeholders, including industry representatives, healthcare professionals, patients, and research institutions. Approximately 30 topics will be discussed, ranging from the effect that increased communications will have on patient enrollment in clinical trials to how patients should be made aware that they are receiving information about an off-label use.

GSK is feeling a bit of a chill in the air. The company reached an agreement with the SEC to pay $20 million to resolve FCPA-related charges its Chinese subsidiary paid bribes to increase sales. As part of the settlement, GSK is also required to provide the SEC with reports regarding its implementation of anticorruption measures for the next two years.

Dermatologists are receiving lots of treats from the industry. A study of 2014 Open Payments data reveals that nearly three-quarters of the country’s dermatologists received payments in 2014. Most were under $50.00, but a few of the doctors received payments totaling more than $90,000.00. The study appears in JAMA Dermatology.

These are frightful times at Mylan as the company agrees to pay $465 million to settle claims it overcharged Medicaid for EpiPen. The company has come under intense fire for its pricing practices related to the product. In agreeing to the settlement, Mylan did not admit to wrongdoing.

The news of the FDA’s public hearing on communication related to the unapproved uses of drugs and devices is encouraging. Hopefully, after the forum, the agency will move quickly on the release of new guidance. As court decisions are discussed in the media and more public hearings are announced, now is a great time to reinforce appropriate promotional communication through the release of updated training.

With that, we close our autumnal edition of the Compliance News in Review. One final note – if you’re attending the Pharmaceutical and Medical Device Compliance Congress next week, stop by Booth 404 in the exhibit hall and say “boo!”

Thanks for reading and stay compliant!

The Pharmaceutical and Medical Device Compliance Congress: A Preview

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The Seventeenth Annual Pharmaceutical and Medical Device Compliance Congress gets underway in just a few short weeks. The annual gathering provides an opportunity for industry professionals and experts to learn from one another and hear from representatives of enforcement agencies. Whether your focus is international compliance, U.S. compliance, transparency, or risk assessment, the conference has something for everyone. We’ve reviewed the agenda and compiled a list of what we see as some the most compelling presentations.

Several sessions focus on compliance issues in managed markets. The preconference Managed Markets 101 review covers private payer systems, market access programs, and government payer systems. The session should provide helpful content and practical examples for those needing to train managed market personnel and salespeople.

If you’re not able to attend the preconference, there are also two managed markets mini summits on Day 2. The morning session covers compliance issues affecting managed markets in general and the afternoon one is focused on audit and monitoring issues. We expect both to spark worthwhile discussions among panel and audience members.

The Pharmaceutical Compliance Forum planners always do a great job of scheduling a variety of sessions dealing with compliance issues in markets outside of the U.S. This year is no exception, with preconference, plenary, and breakout sessions addressing global issues. Since the first transparency reports were filed by EFPIA members over the summer, unpacking what has been learned from the data, and discussing the challenges faced by companies thus far, will be of interest to anyone involved in global transparency.

We are also interested in the keynote address on Day 1 by Sophie Peresson, LLM, MA, Director of Pharmaceuticals & Healthcare Programme for Transparency International. (FYI – the printed brochure has this listed as the keynote for Day 2, but the website has it scheduled as the second keynote on Day 1.) The organization, well-known for its work addressing corruption, recently focused its attention on the pharmaceutical industry, so Ms. Peresson’s presentation should be valuable for companies mapping their future transparency training plans.

Finally the day two mini-summit titled, “Reimbursement Support, Patient Assistance Programs, Coupons, and Charitable Foundations” is another one on our radar. Enforcement agencies have sharpened their focus on these programs, and the area could be the next target for investigators. The panel includes both industry and legal professionals.

Now, we’re interested in your opinion. If you’re attending the conference, stop by the PharmaCertify™ booth in the exhibit hall between sessions and let us know what you think of the sessions and speakers. While you’re there, don’t forget to enter our drawing for a Bose® Soundlink® Bluetooth® speaker.

See you in Washington and stay compliant!

Compliance News in Review, September 15, 2016

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Illinois tackles illegal drug promotion by Insys; the ABPI calls out two member companies for breaking promotion rules; the Australian legislature shines a light on corporate crime and Medicines Australia reports on payments to doctors; and AstraZeneca settles with the SEC…all in this edition of the Compliance News in Review.

You had to know it wasn’t far away when “pumpkin spice everything” started appearing on store shelves. After the long hot summer, the staff here at the Compliance News in Review couldn’t be more excited that football is back, and cooler days with it (hopefully). Whether you’re a fan of college, or the league where they play for pay, the season is short, but that’s what makes it so special. Yes. football is now our focus, but not so much that we won’t continue to provide you with all the life sciences compliance news fit to blog. So, strike up the band, we’re ready to take the field on this edition of the Compliance News in Review.

The Illinois Attorney General is lining up against Insys. The state has filed suit against the company for illegal marketing of its fentanyl drug. The drug is approved for treating pain in cancer patients, but the AG alleges the company has been marketing the drug for treatment of other types of pain. The company also encouraged doctors to write prescriptions for higher, more expensive doses of its product, despite FDA recommendations to use the lowest dose of opioids possible, according to the suit.

The Association of the British Pharmaceutical Industry (ABPI) threw a flag on Hospira and Napp Pharmaceuticals. The organization has accused the companies of breaking the rules regarding promotion of biosimilars. An investigation found that Napp Pharmaceuticals made inappropriate payments to physicians attending a meeting that was deemed an advisory board. Hospira allegedly invited U.K. doctors to attend a meeting outside the U.K., which was a not a genuine advisory board, where their drug was promoted.

The Australian legislature will huddle about the state of its anticorruption law. After two Australian companies were implicated in a case involving the bribery of foreign officials, a member of the Australian senate decided to relaunch a committee to address corporate corruption. The mission of the committee is to improve Australia’s response to corporate crime and the senator noted that compared to bribery laws in the U.S. and U.K., Australia’s law is inadequate.

The “score” regarding industry payments to physicians in Australia has been posted for public review. Between October 2015 and April 2016 doctors received $8.5 million from industry according to a report from Medicines Australia. The organization says this report provides patients with more information than ever before about the relationship between doctors and the industry, and that the organization’s “standards for ethical and transparency will improve the Australian health care system.”

Thanks to an “ineligible receiver” call from the officials at the SEC, AstraZeneca has agreed to pay $5.5 million to resolve FCPA related charges. The SEC alleged that the company did not have proper internal controls in place related to interactions with foreign officials – mostly healthcare providers – in its China and Russian subsidiaries. The agency contends that improper payments, in the form of cash, travel, and gifts, were documented as bona fide business expenses. While AstraZeneca did not admit or deny any wrongdoing, it did cooperate fully with the investigation.

This week’s review had a decidedly foreign flavor. Where compliance outside the U.S. is concerned, we recall a quote from Pulp Fiction (bet you never thought a Tarantino film would ever be referenced in blog post about compliance) when Vincent Vega is discussing the differences between European countries and the U.S. “They have everything there we have here. It’s just a little bit different.” The same can be said for compliance issues. While the principles or requirements related to drug promotion may be the same here and abroad for the most part, there are small differences between what is permitted in the U.S. and what is permitted around the world. Life sciences companies must train employees about practices that are appropriate when conducting business outside the U.S., particularly in their interactions with non-U.S. HCPs.

With that, the time has expired on this edition of the Compliance News in Review. Don’t forget to click that blue button on the right to “follow” our blog so you’ll receive notifications when we post new content.

Until next time, stay compliant and enjoy the games!

Making the Most of Face-to-Face Time with Learners

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by Lauren Barnett

Time in front of learners is a valuable commodity. Everyone throughout your organization is busy with his or her designated responsibilities, and the demands on a learner’s time makes scheduling training time challenging. If the learners are field-based,  the opportunities for face-to-face time are limited and everyone is scrambling for their share. So compliance trainers need to make the most of live training time in order for learners to walk away with an understanding of how the policies, rules and regulations affect their jobs day-in and day-out.

Effective and targeted compliance eLearning is one solution. Deploying eLearning before the live session gives trainers the ability to focus their live training time on the application of policies, and any changes in the working environment that might affect the exact interpretation of the rules.  It also allows the trainers more time to delve into learners’ questions about how to handle the situations they face.

Don’t Forget the WIIFM

When learners come to a live session with a baseline knowledge, trainers can utilize role-playing scenarios or interactive games to make the foundational knowledge presented in the eLearning more meaningful. This approach sharpens the WIIFM (What’s in It for Me) in the learner’s mind. When learners understand how the laws and regulations actually affect their daily activities, the information “sticks” even more and the potential for behavior change is stronger.

The Landscape Might Change 

While laws, regulations and policies may not change often, the environment in which learners operate is fluid. Using eLearning courses for foundational training, before the live session, allows trainers to spend that face-to-face time discussing any changes in the company business or the industry. For example, over time, an off-label use of a product may emerge, or a company may enter into a foreign market, creating new risks and/or laws that have to be addressed through training. By deploying eLearning to cover any new laws or policy basics, trainers can use their live time to discuss the more specific details of how those changes are played out in the field.

Leave Time for the Gray Areas

Inevitably, the application of compliance policies and regulations is sometimes left open to interpretation. The nature of those policies can leave those in the field mired in confusion and lost as to how to apply related policies. When you train the foundational knowledge through eLearning, face-to-face training time can be used as an opportunity to answer those questions and educate the learners about how to conduct themselves in a compliant manner. That type of feedback and dialogue represents a major step toward reducing risk and strengthening your compliance culture, as staff learn how to apply the principles, even when there isn’t a ready-made answer in the policy.

Make it Stick

Face-to-face time with learners is a valuable and precious commodity, and as a trainer, you need to seek methods for making that time as rewarding as possible. Deploying a baseline of eLearning courses, such as those found in the PharmaCertify Compliance Foundations™ curriculum, frees the trainer to spend that time detailing how the laws, regulations, and policies affect the learners’ daily activities. When learners understand compliance is not a set of draconian rules, but rather integral facets of what they do daily, the information is more likely to stick with learners and drive more ethical and compliant behavior.

Lauren Barnett is a Compliance Training Content Specialist for the PharmaCertify™ division of NXLevel Solutions. When she is not identifying subjects for the company’s Compliance Foundations™ suite of off-the-shelf eLearning modules, or working with clients to create custom training content, she can be found gleefully volunteering for her daughter’s high school band and theater programs.