Code of Conduct

Dear Connie the Compliance Training Director Returns!

PharmaCertify Team , , , , ,

Great news! Connie the Compliance Training Director has emerged from her self-imposed quarantine and returned to the North American Headquarters of PharmaCertify. For her first post-pandemic post, Connie answers a question about the appropriate compliance training mix for product launch…

Dear Connie,

Connie the Compliance Training Director

I’ve read the recent post on this blog about the formula for a better compliance training curriculum, and I completely agree with the rationale for a combination of foundational training, reinforcement, and performance support. I am a compliance officer for a pharmaceutical company in the Northeast and my company is rapidly approaching our PDUFA date (fingers crossed) for a new product.

We’ll soon be hiring a new field team that is highly experienced in the industry. Do you have suggestions for the tools to use along each step of the continuous training rollout? I want to make sure I get this right, so that we have a successful launch while being sure our team stays compliant.

Sincerely,

Skittish in Schenectady

Dear Skittish,

I understand your concern! Product launch is a time fraught with compliance risk. Whether this is your company’s first product, or one of many, the risk of not fully preparing a new sales team can keep you up at night. But as opposed to being skittish about this, I dare say you should view a product launch as a terrific opportunity to ramp up the compliance knowledge in the company and build your reputation as a compliance training hero! Here’s how:

Build a Solid Foundation

From a foundational standpoint, I suggest you start with training on interactions with health care professionals to refresh the reps on topics such as the rules around gifts, meals, and consulting arrangements. If you’re doing speaker programs, you’ll also want to cover guidance around those on a comprehensive level. Enforcement around the programs continues to be a focus, with the most recent settlement costing the company $900 million in settlements…yikes! And don’t forget to include your policy on virtual meetings now that they’ve become more commonplace. (By the way, my friends at PharmaCertify have added Managing Speaker Program Risk to their list of customizable off-the-shelf eLearning modules. It’s worth a look, so email them at info@pharmacertify.com to see a demo.)

Launch Screen from the Compliance Foundations Module, Interactions with Healthcare Professionals

Make sure regulations, such as the Anti-Kickback Statute and False Claims Act, are covered in general terms and in context of what they mean for the reps as they interact with HCPs. You could even shape some of the foundational training around the tenets of the PhRMA Code – it’s always a reliable starting point.

You might also think about converting your code of conduct from a static document you hope they read now and then, to a learning tool that reminds them of the core tenets of how they are expected to conduct themselves. And rote repetition of the code in electronic form does not rise to the level of effective training. A well-designed and fresh course will help familiarize the new reps with specifics of your code. (FYI – the PharmaCertify team has lots of fun ideas for how to bring your Code to life!)

One final note on foundational training: the rest of your staff (i.e., your non-commercial employees) need a basic understanding of the health care compliance principles that govern how you do business, so they will need training, too. In this time of increasing enforcement, you need to be able to demonstrate that everyone in your company has received essential compliance training.

Reinforce and Refresh

The possibilities for on-going refresher training don’t stop at the code of conduct though. Consider integrating microlearning modules (PharmaCertify calls them QuickTakes) covering topics pulled from your larger training programs into a curriculum campaign. For example, since gifts and meals present a high level of risk, a five-minute module focused on items of minimal value, cash and cash equivalents, as well as in-office meals, out-of-office meals, and meals at third-party events, is a great way to keep the rules top of mind.

Also, too many people fall into the trap of thinking microlearning just means “short.” My buddies at PharmaCertify take a different view. They define microlearning as any training component designed to reinforce foundational training as part of a continuous learning plan. The formats could include live-action or animated video, workshops, and game-based training, and even strategically delivered quizzes and assessments. The idea is to keep the training nuggets flowing for higher risk areas, which increases retention and enhances learning.

On the live training front, think about games to ramp up learning. If you’ve ever been in front of a group of reps playing any game, you know how they like to compete! As Gordon Gecko said in the movie, Wall Street, “Competition is good.” I know, he really said “Greed is good,” but I got your attention with that one, didn’t I?

This is JEOPARDY! In fact, it’s the only officially licensed JEOPARDY game on the market.

Look for games that have a familiarity to them. A Jeopardy game is great and if you’re interested, I can get you a demo for the only officially licensed compliance Jeopardy game on the market. It’s also easy to customize, so you can add the categories and topics you need to reinforce.

You can take the event to another level by pitting regional teams against each other and adding music, sound effects, and prizes to the mix. If done right, the games will have the participants saying, “that was the best compliance training event I ever attended!” Trust me, I’ve heard it.

There is a trend toward more creative live and virtual compliance workshops, and in my opinion, it is long overdue. Simply having a representative from the compliance department speak to a PowerPoint deck might not cut it in the view of regulatory bodies, and it certainly is not going to accomplish any worthwhile learning objectives.

An image from the virtual Compliance Escape Room Workshop

I even saw a virtual escape room utilized during one recent workshop. In this case, participants solved clues about three scenarios as they competed in teams to “escape” the rooms. It was a big hit at the national sales meeting and won a gold award for Best Advance in Compliance Training from the prestigious Brandon Hall organization.   

Support Their Performance

If there’s one element of the formula for effective compliance training that is most neglected, it’s performance support. Throughout my career in compliance training, I have too often seen training viewed through a myopic lens that is only focused on foundational training and occasional reinforcement. Performance support tools broaden the scope of your training campaign and provide just-in-time guidance.

Support materials can be as varied as interactive PDFs launched on the learning management system, animated video played through the corporate intranet, or an interactive microsite for sharing policy and code information. In addition, tip sheets and reminders about best practices and policies can also be sent directly to reps’ phones or iPads to support them with the information they need in the field.   

Summary

I wish you well with your efforts and good luck with that PDUFA date! Product launch may, at first glance, be nerve-racking from a compliance standpoint, but when you take the time to analyze your current training against your risk, then develop a continuous curriculum to be delivered across your reps’ timelines, you’ll be surprised at how seamless it can be. Just keep that formula for an effective curriculum (foundational + reinforcement + performance support) at the forefront of your planning and I guarantee you’ll sleep much better at night.

Soar high, you hero of compliance training!

Thanks for your question,

Connie the Compliance Training Director     

Lessons Learned at the 19th Annual Pharmaceutical and Medical Device Compliance Congress

PharmaCertify Team , , , , , , , , , , , ,

Lesson 2: The More Things Change…

Tessa Hoyer of PharmaCertify greets attendees at the 19th Annual Pharmaceutical and Medical Device Compliance Congress.

The French journalist and novelist, Jean-Baptiste Alphonse Karr, is credited with coining the phrase, “the more things change, the more they stay the same.” For anyone who has attended multiple compliance conferences in the last five years, his words certainly ring true. Terms like “partnering with the business,” “tone from the top,” and “third-party risks” are still staples during conference presentations and this year’s Pharmaceutical and Medical Device Compliance Congress was no exception. For good reason.

As an example, the Compliance 3.0 presentation on Day 2 of the conference began with one panelist expressing his concern that “we still have to fight for a seat at the table.” In other words, while the concept has been bandied about for years now, the reality is that raising compliance to the organizational level of respect it requires to affect true behavior change is still a struggle. He and his co-presenters emphasized the need to not only find that seat alongside the businesses but truly understand their business policies as well as what they do and who they are. As another presenter put it, “bring value to the business as a compliance representative, educate them every step of the way, and help them educate their people.” She added, “when they get to the point where they are doing it themselves, that’s nirvana.”

Not surprisingly, the need to train and manage third-party vendors continues to be stressed. In the session covering the Foreign Corrupt Practices Act, one government representative even delved into the need to extend the corporation’s culture to the vendors. She added “you really need to know your third-party vendors and they need to understand you. You need to know who it is that is making payments on your behalf.” The presenters in the Third-Party Lifecycle Management session agreed, citing the need to “have vendors take the same training that is rolled out for your employees. Treat them as partners and make sure they understand the risks involved.  They are more likely to care about being compliant if they feel like a partner and if they will be held responsible.”

As with the conversation and debate over an “ethics-based approach to compliance,” concepts like “tone from the top,” “partnering with the business,” and “third-party risks” warrant our focus and consideration simply because they are that relevant and critical. Industry conferences offer the valuable opportunity to hear our peers share their latest insights and success stories around the themes that seem to drive the conversation. While the world of life sciences compliance is evolving, in some cases, the more things change, the more they stay the same…at least at the compliance conferences.

Thanks for reading!

Sean Murphy
Editor
Compliance Training Intelligence Blog

4th Annual Life Sciences Compliance Congress for Specialty Products: A Preview

PharmaCertify Team , , , , , , , , , , , ,

CBI’s Compliance Congress for Specialty Products kicks off next Thursday, September 13th in Boston, and Dan O’Connor, Senior Vice President for PharmaCertify, will be there to catch up with our clients and colleagues and hear industry leaders and government regulators share strategies for proactively addressing current risks for specialty pharmaceutical manufacturers.

We’ve reviewed the conference agenda and here are the sessions and presentations we are looking forward to in particular:

Day One, Thursday, September 13

Prosecutors’ Perspectives Panel

Following the opening keynote address, the conference begins with this prosecutor panel focused on biotech and specialty pharma companies. Charles Grabow, Assistant US Attorney from New Jersey, and Gregg Shapiro, Chief of the Affirmative Civil Enforcement Unit for the DOJ in Boston, will be joined by Jane Yoon from Paul Hastings, LLP, to discuss the high-risk areas for this unique industry group. Government panels typically offer some of the most compelling and important information during conferences and since this conference is focused on such a defined segment of the industry, the conversation should be revealing and educational.

Coping Strategies for the Lonely Compliance Officer

In addition to having the most creative name of any of the presentations, this session features three professionals facing the challenges that come with being a compliance professional for an emerging pharmaceutical company. We will be curious to hear how Heather Godling from Sobi, Francisco Ribeiro of Tesaro, and Sarah Whipple at Akebia Therapeutics, creatively utilize the limited personnel and resources available to them to build and maintain a strong culture of compliance.

Expert Panel: Evaluate the Risks Associated with Disease State Awareness and Other Pre-Launch Activities

The “Pre-Launch Activities” part of this title caught my eye. No matter their growth stage, all companies need to be aware of the compliance risks and concerns they face now and as they progress toward launch. That extends to compliance policies regarding interactions with healthcare practitioners. Ideally, compliance training for a new sales team should be built and planned before the product is commercialized.

Ensure Transparency in Contributions to Independent Patient Assistance Foundations
And
Reboot Your Approach to Patient Assistance Programs (PAPs) and Reimbursement HUB Support  

Patient support programs are an emerging enforcement trend in the pharmaceutical industry as more and more companies enter into settlements at least partly related to the programs (e.g., Aegerion, United Therapeutics, Jazz Pharmaceuticals). Add the high cost of specialty pharmaceutical products to the mix, and it’s no surprise that CBI has scheduled back-to-back sessions on this important topic.

Day Two, Friday, September 14

Daybreak Discussion: Specialty Café – Forecasting Priorities from Now to 2020

In a novel presentation structure spread across two consecutive time slots (8:15 – 8:40 and 8:45 – 9:10), attendees will have the opportunity to sit in small groups, share ideas and listen to their peers discuss three timely topics: Risk-based Approaches for Advanced Therapies; PBM Contracting Considerations; and Compliant Medical Affairs and Commercial Interactions. The format offers a welcome twist  from the typical large group presentation and should lead to a compelling exchange of peer-to-peer ideas. It’s a great idea.

Explore the Trends in Drug Pricing Legislation and Other State Initiatives

John Oroho, from Porzio Life Sciences, LLC, is a respected and established thought leader in the life sciences compliance industry and his presentation is a can’t miss opportunity to hear the latest news and regulatory updates on these two ever-evolving topics.

Scale Up Your Compliance Program for Global Operations

Going global can be fraught with risk and compliance traps. In terms of anti-bribery alone, pharmaceutical companies need to now consider Loi Bertrand, the EFPIA Code, the Medicines Australia Code of Conduct, and a cadre of emerging codes and regulations around the world.  These on-going changes in the global landscape make the presentation by Masha Chestukhin of Sanofi, and Darryl Williams of MediSpend, an important pre-lunch session.

GDPR is Here – Now What Do We Do?

Are you confused about the General Protection Privacy Regulation (aka, GDPR) and its impact on you as a pharmaceutical compliance professional? You’re not alone. The questions concerning details like data inventory and documentation abound, and what exactly does it mean when data subjects have the “right to be forgotten?” What about training? Who needs to be trained? How does it impact the field employees interacting with HCPs? We look forward to hearing answers, ideas and opinions from David Ryan, Vice President, Associate General Counsel, Chief Compliance Officer at Epizyme and Trish Shorey, Privacy Officer, Global Compliance and Risk Management at Shire.

If you’re attending the conference, we want to hear from you. Let us know what you think of the sessions and presenters, and conference content. And of course, if you see Dan, he’d be happy to share demos of our newest compliance training solutions and discuss how we help clients build a stronger culture of compliance and reduce risk.  

Thanks for reading!

Connie the Compliance Training Specialist Returns!

PharmaCertify Team , , , , , , ,

Welcome to a new edition of “Dear Connie the Compliance Training Specialist,” where we answer questions about life science compliance training concepts and discuss new ideas for making that training more effective.

This week: create a campaign to make it stick!

Dear Connie,

I am a compliance training manager for a mid-sized life sciences company in Pennsylvania and I am worried about our training on interactions with HCPs. We rolled out a new policy last year, and in January I launched comprehensive training on that policy. But based on our monitoring and data from our hotline, employees are still forgetting the key concepts and principles from their training. Connie, where do I go from here?

Signed,

Perplexed in Perkiomen

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Dear Perplexed,

Your challenge is a common one, but there are steps you can take to make the training more memorable. Just this month, at the 3rd Annual Life Science Compliance Training Conference, a number of your peers talked about how they use a campaign approach to make training more effective and make it stick with their learners.

Create a Brand

Develop a brand for the training campaign. Branding works for your company’s products, and it will work for your compliance training. Every time employees interact with your compliance training “brand” they form associations. The images you select reinforce those associations. Make sure your brand communicates the importance of integrity, clearly and consistently. Carry that branding throughout the training and on all communication.

Less is More

I suggest smaller training delivered throughout the year, rather than a longer more cumbersome course once or twice a year. When you take a “less is more” philosophy and keep seat times to no more than 15 minutes per module, you’re likely to see an uptick in retention. Don’t forget to keep the training flowing continuously, and build in follow up assessments, microlearning and contests to reset the forgetting curve that inevitably occurs after they complete the initial module or workshop.

Build the Messaging

The communication plan is critical too. Clear and concise messaging about the importance of the training, needs to be delivered in all three stages: pre-launch, launch, and post-launch. You should seek help from the stakeholders to deliver the messaging (one presenter at the conference said her company refers to these people as “compliance connectors”). The district managers are important in the process. They are the ones talking to the sales representatives on a regular basis, so you need to get them on board and funnel the messaging through them. Remember, communication is an ongoing process, you should constantly refine, adjust, and expand communications as you monitor the results of the training.

I could talk for hours about the need for a campaign approach to life sciences compliance training. I haven’t even touched on the need to solicit and evaluate learner feedback. Fortunately, my friends at PharmaCertify (that’s the life sciences compliance training division of NXLevel Solutions) have years of experience building training plans, and they’d be happy to share more ideas with you. Email my buddy Dan O’Connor at doconnor@nxlevelsolutions.com to see what they’ve done for other life sciences compliance clients.

Thanks for the great question and good luck!

Signed,

Connie the Compliance Training Specialist

A Medical Device Issue of Dear Connie, the Compliance Training Specialist!

PharmaCertify Team , , , , , , , , ,

Welcome to “Dear Connie, the Compliance Training Specialist,” where we answer questions about a panoply of compliance training topics and present solutions for strengthening your compliance culture and reducing risk.

This week: Clearing the Confusion of Medical Device Codes

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Dear Connie,

I am a new compliance training manager for a growth-oriented medical device company near Boston, Massachusetts. I always look forward to your tips on training for the life sciences compliance industry in general, but in this case, my question is specific to the medical device space.

My company is growing rapidly overseas and I don’t have a good handle on the details of all the codes that govern our industry. I have created my own spreadsheet with what I think I need to know for each, but I sure would welcome a more official resource for comparison. As I start the process of analyzing my curriculum, how do I know I am targeting the right employees and third-party vendors with the right code training?

Can you help me sleep better, Connie?

Quizzical in Quincy

Dear Quizzical,

I feel your pain and your sleeplessness. The proliferation of medical device codes around the world can be confusing for those of us trying to manage risk. In addition to the AdvaMed Code, you need to be aware of the AdvaMed Code of Ethics on Interactions with Health Care Professionals in China, the MedTech Europe Code of Ethical Business Practice, and the APCMed Code of Ethical Conduct for Interactions with Health Care Professionals…whew that’s a mouthful and a training plateful.

Fortunately, AdvaMed has published a chart comparing the purpose and scope of each one, as well as topics like healthcare professional training requirements, provisions on payments of royalties, sales and promotional meetings, entertainment and recreation, support of third-party educational conferences, and more. I suggest you download the chart from the Resource Center page on the AdvaMed website and read it carefully – there is a plethora of helpful information there.

By the way, since you mentioned that you’ve started an analysis of your curriculum, I also recommend the article published by my friends at PharmaCertify for the industry publication, Life Science Compliance Update. It’s called Improving Outcomes: Analyzing a Compliance Training Curriculum to Reduce Risk and the reprint is available for download on their website.

Thanks for the great question. I always enjoy hearing from my friends in the medical device world.

Good luck and good training!

Connie

News and Notes from the 15th Annual Pharmaceutical Compliance Congress

PharmaCertify Team , , , , , , , , , , , , , , , , , ,

CBI’s annual Pharmaceutical Compliance Congress, which took place April 23rd to the 25th in Washington DC, featured industry leaders and government representatives espousing the usual best practices for building and maintaining an effective compliance program, but this year’s agenda offered a few surprises and changes in the regulatory wind. The notes below highlight some of the sessions we found to be particularly interesting and newsworthy.

Day 1

CCO Exchange – Adapting and Evolving Compliance Programs in Support of Innovation

Following the opening remarks and a session covering politics and the pharmaceutical industry, the conference kicked into gear as Maggie Feltz of Purdue Pharma, Jennifer McGee of Otsuka, Jill Fallows Macaluso of Novo Nordisk, and Sujata Dayal of Johnson & Johnson discussed their process for “partnering with business” in the company to maximize the strength of their compliance programs. The panelists stressed the importance of establishing a relationship with business that is built on open dialogue and trust.  Documentation is also key to that relationship and as one panelist pointed out, “the government cares about how you document that you are preventing issues.” It’s important to “shape the way you are perceived in the relationship by using business language,” she emphasized, and to measure your own effectiveness by simply determining whether business is inviting you back to the table. Your compliance program is only effective if you have a seat at that table.

Once the partnership is established, you need to “get the business to think and talk about risk and conduct a benefit-risk analysis,” according to one panelist. Another reminded the audience that Corporate Integrity Agreements (CIAs) hold important clues about topics of focus for the government. This is particularly enlightening considering the recent Aegerion and United Therapeutics CIAs that dealt with third-party patient assistance programs, a topic discussed throughout the conference.

The panelists also covered working with third-party vendors and the need for monitoring and testing of those vendors to ensure they are complying. As one panelist put it, “you need to be sure those companies are applying your standards.”

Stakeholder Spotlight – Strategies for Collaborating with Business Partners to Enhance Compliance Enterprise-Wide   

Gail Cawkwell, Medical Affairs at Intercept Pharmaceuticals, Cecilia Matthews, Human Resources at MedImmune, Gregory Moss, Deputy General Counselor at Kadmon, and Gary Cupit, CEO of PortA Pharmaceuticals provided the business perspective on the compliance/business partnership. The panelists reiterated key points from the CCO session, with one emphasizing the need for the two departments to tackle the issues together as business partners and another seeing compliance not as a goal, but “a base objective that underlies everything.”

One panelist emphasized the need to be aggressive in the approach, pointing out that she is the person “bothering the compliance department, digging into SOPs, asking why they do things that way, and asking how each policy helps the company.”  She prides herself on partnering with compliance to “find a better way to do it.”

Highly-Acclaimed U.S. Healthcare Fraud and Enforcement Panel – Past and Present Prosecutor Parley

A large group of current and past government enforcement representatives covered the current compliance risks facing the life sciences industry. The session started with a discussion about the nation’s opioid crisis and how each office is addressing the epidemic. One current assistant U.S. attorney summarized the threat to the industry succinctly, “If your company is involved in opioids at all, you are under intense scrutiny.”

In one of the more interesting moments of the conference, the panelists pointed out that the focus on off-label enforcement has shifted away from large pharmaceutical companies to smaller ones. According to one speaker, small companies and startups are under greater pressure to sell and to save money, especially if they are funded by venture capital companies. That leads to a higher risk of off-label promotion.

Continuing a theme, prescription assistance programs and patient charities were addressed in relation to kickback risk. As stated, “any coordination between the charity and the company that shows the company is just trying to pay for its product being prescribed is a concern.” At least two current regulators supported the idea of self-disclosure and being honest about potential violations. “Being candid about where the compliance program has fallen short and the steps the company is going to take to correct the problem is important,” one of them said.

The group of former regulators, who mostly now serve as industry counsel, touched on exclusion as a risk. While it may be considered a rarely-sought tool, prosecutors have the threat of exclusion available to them as leverage. They also delved into the importance of data and reminded the audience that prosecutors are indeed scouring Sunshine Act data.

Patient Assistance Programs and Reimbursement Hub Services Compliance – A New Wave of Enforcement Actions

Attendees were provided five options for the first breakout sessions. The PAP and Hub Services panel was moderated by Jane Yoon of Paul Hastings LLP, and featured Peter Agnoletto of Sanofi, Sarah Whipple of Akebia Therapeutics, and Evan Bartell of KPMG LLP.

The discussion began with a polling question asking attendees where the management of donations sits in their organization. Corporate Social Responsibility and the Grants Committee were the top answers. The question led to a discussion over best practices, with one speaker warning, “you at least need to take commercial out of any involvement with donations.” Another admitted that not having a say in how the money is spent is hard concept for the business to grasp but the separation is important.

In the next polling question, attendees were asked if they monitor relationships and interactions with the foundations. 57% replied yes, and 28% said no. The panel reminded the audience that recent CIAs included the stipulation that those relationships are monitored.

Another question was focused on sales representatives and their involvement with donations. 48% of the audience said their reps are provided with talking points. Panelists suggested that if the sales reps are involved, compliance needs to understand how the information is being used. Clear guidelines need to be established and the reps need to be trained on those guidelines.

Off-label Communications – Deep Dive into the New Regulatory Updates and Actions

Angela Rodin of KPMG LLP and Laura Terrell of DLA Piper LLP presented the update on the status of off-label promotion trends and enforcement in the industry. Starting in 2012, enforcement shifted, as companies argued that off-label marketing is protected under the First Amendment and therefore cannot be prosecuted under misbranding provisions of the Food, Drug, and Cosmetic Act (FDCA). One presenter pointed out that while the government is no long pursuing off-label promotion as a stand-alone FDCA case, it continues to enforce False Claims Act (FCA) and Anti-Kickback Statute (AKS) cases related to off-label promotion.

The bottom line is that even with strong support of free speech as a defense of off-label promotion, life sciences companies still need to be cautious. Clear and effective training is still needed.

Social Media – New Challenges and Updates

Elizabeth Kim of Loeb & Loeb LLP began the social media presentation with the underlying premise that while the digital landscape has changed dramatically over recent years, the legal landscape remains the same. Even on social media, promotional statements cannot be false or misleading and communications must be consistent with labeling and fair-balanced.

Social media is challenging, the presenter stressed, because it promotes a dialogue, which means the company has a lack of control over the conversation. But there are some steps companies can take that at least help with the control. The ability for readers to comment on posts can be turned off on Facebook. No such control exists with Twitter. In addition, key words can be flagged on Facebook to help monitor comments. Unfortunately, as the presenter noted, most companies lack the resources and personnel to properly monitor social media outlets.

She also mentioned that while companies have no obligation to correct third-party, independent comments, public, unsolicited requests for off-label information must be met with a limited response to contact Medical Affairs only. “If you do reply,” she said, “responses should be narrowly tailored. Watch out for getting into arguments.”

The FDA’s Office of Prescription Drug Promotion (OPDP) has issued 233 warning letters over the last ten years for omitting information, minimizing risk information, and overstating efficacy claims on social media. As existing platforms evolve, and new ones appear, the need for updated training to ensure your field-based employees are abiding by laws like the FCA and FDCA, as well as OIG guidance and the PhRMA Code, is critical.

Medical Affairs and MSL Oversight

The Medical Affairs panel included Tina Beamon, Alicia Temoche, and Stephanie Macholtz from Alexion Pharmaceuticals, and Christine O’Connor-Fiore from Boehringer Ingelheim. The session began with the panelists establishing the general rules for how Medical Affairs may interact with healthcare professionals. Attendees were reminded that Medical Affairs can “do things R&D and Commercial cannot do” and “they are not limited to the label.” MSLs provide training to consultants for speaker programs but in the words of one panelist, “they are not Commercial and their integrity must be protected.”

The panelists admitted that the model for Medical Affairs and Commercial interactions has changed in reaction to marketplace changes. Medical Affairs should share insights as long as those insights are not off-label. “The walls between Commercial and Medical Affairs are coming down,” she said, “and a framework needs to be in place to protect the integrity of the MSL.”

Behavioral Compliance – Using Psychology to Make Programs More Effective

In one of the more unique sessions I’ve witnessed in years of attending compliance congresses, this session focused on behavioral compliance as a tool for generating more compliant outcomes. Yogesh Bahl, of AlixPartners, Kevin Ryan of Novo Nordisk, and Charlene Davis of Sun Pharmaceuticals provided conceptual concepts around the philosophy and practical application of behavioral compliance, using ideas known as “ethical nudges.”

The session began with the audience being asked to provide feedback on which of two compliance posters they thought were more effective. Essentially, one reflected a “rules-based” approach, and the other a “values-based” one. The values-based poster was the more popular choice and the content of the session supported that approach. The underlying premise behind the ethical nudges is that “people become ethical by doing ethical things.” Ethical nudges were essentially defined as “interactions based on the understanding of internal decision-making to promote desirable choices.” They included “read and affirm” documents presented right before a critical HCP interaction, visual cues like signage and posters, and micro-training launched strategically in conjunction with the need for ethical decision making.

Critical CIA and Enforcement Learnings – Zero-In on Emerging Trends to Elevate Compliance Safeguards      

The key points of this session were no surprise considering the oft-repeated focus of recent CIAs. BJ D’Avella of Deloitte and Touche LLP and Seth Lundy of King & Spalding LLP reminded attendees that “the focus of CIAs had shifted to interactions with patients, and more than ever, companies need to have a Risk Assessment and Mitigation Plan (RAMP) in place.” That RAMP needs to include activity-based risks in addition to the usual product-based risks.

One of the presenters pointed out that the OIG is focusing on a “smaller number of CIAs that send messages to the industry.” He reminded the audience that CIAs are not laws, but they are a strong indicator of where to focus risk mitigation efforts.

Day 2

CCO Scenario Symposium – What Would You Do?

After a review of the sessions and events of Day 1 by Michael Shaw of GlaxoSmithKline, Day 2 began with this session, during which panelists were asked to participate in a mock case study of “Bad Pharma Co” and expand on lessons learned from this fictional company. Beth Levine of Regeneron Pharmaceuticals, Ashley Watson of Merck, Jerald Korn of Tesaro, and Keith McGahan of Spectrum Pharmaceuticals were asked to discuss the optimal organizational structure companies like the mock one presented in the case study. One presenter felt that having compliance as part of the legal department was a benefit because it gave her greater access to the CEO and others in the board of directors. Others felt that if compliance has that type of access, “it doesn’t matter where they sit.”

Other scenarios brought up in the case study led presenters to offer tips on dealing with compliance situations and those who raise the concerns. For example, one speaker emphasized that “no matter the source, the company’s obligation is to search for the facts of the case.” Speculation about the whistleblower and his or her credibility should not come into play. Also, “if someone sends information about a violation anonymously, it needs to be kept that way.”

Meeting of the Enforcement Minds

Heather Johnson from the Federal Trade Commission, Sally Molloy from the Department of Justice, and Eric Rubenstein from the OIG presented their suggestions for companies to keep their compliance programs attuned to current regulatory challenges. On the topic of bribery for example, one presenter suggested that “internal controls need to be robust and designed so that they are not siloed. It’s all bribery.” Another emphasized that recent trends point to Medicare and Medicaid fraud as a primary source for qui tam cases.

Beyond the Seven Elements of and Effective Compliance Program – What Else Are You Doing?

As a compliance training company, this session, featuring Jerald Korn of Tesaro, Chad Morin of bluebird bio, and Gregory Moss of Kadmon Holdings, held particularly interest for us. As one presenter stated, “creating a brand for the compliance department is a fun way to convey important information.” That holds true for the training as well, and we work with companies to create a continuous, engaging, and “fun” curriculum.

Another speaker noted the importance of being creative in the policies to help ensure compliant behavior, as well as the need to establish a collaborative culture. As stated, “you’re not trying to check the boxes on all seven elements, you’re trying to build a robust program that is effective.”

Existing and Emerging State Laws Governing Transparency Reporting

The state laws presentation, with Maggie Feltz and Michael Grandison of Purdue Pharma, and Brian Bohnenkamp of King & Spalding, LLP, began with tips for managing aggregate spend:

  • Train company-wide, not just the sales force
  • Train, retrain, then train some more
  • Monitor throughout the year

The panel pointed out that state laws fall into three categories; drug pricing transparency, aggregate spend laws, and sales representative licensing and reporting laws. The landscape across all three changes quickly and they expect 2018 to be as busy as 2017.

In recent state-related news, Maryland’s law was found to be unconstitutional and according to one panelist, that “has quieted some of what other states have been considering.” Oregon was brought up as the most challenging law since it “requires documentation to support your documents.” In New Jersey, where the law was passed on the last day of the outgoing administration, one speaker mentioned that Governor Murphy’s team is considering major changes. On the drug pricing front, the panel expects two or three more laws to be implemented.

Obviously, the state law landscape is confusing and changes are happening at a dizzying rate. As one speaker emphasized, diligence, and continuous training is necessary to “ensure every decision-maker is aware of new requirements.”

Maximization of Compliance Resources

I close with what may have been the best session of the entire conference! (okay, I may be a bit biased since this panel included my colleague, and head of PharmaCertify, Dan O’Connor.) Dan was joined by Chad Morin of bluebird bio and Laurie Kathleen Durousseau of Rigel Pharmaceuticals. The session focused on how compliance professionals can best focus their time and energy toward those activities that are most critical during the various growth stages of a life science company from pre-clinical to established.

Starting with a quick poll of the audience, the panel first determined the average size and stage of companies represented. Most of the audience members were an “n of 1” compliance department in a company with 200 or fewer employees that is in the “Clinical” or “First Product” stage. The panel then shared their suggestions for which compliance-related activities to prioritize during each growth stage. In the “first product” stage for example, aggregate spend transparency reporting; government price reporting; specialized training by function; and patient support program design were discussed, among other topics.

The panelists also covered the need for small departments to partner with the business, as well as other departments, to spread the resource load and accomplish the objectives of each stage. For any compliance department challenged with limited resources and personnel, it was a worthwhile thirty minutes of learning. If you missed the conference, Dan would be happy to provide his perspective on the topic. Feel free to contact him at doconnor@nxlevelsolutions.com.

Summary

The world of life sciences compliance is changing, and so is CBI’s Pharmaceutical Compliance Congress. This year’s conference presented a compelling balance of traditional content that newcomers to the field should find valuable as a base of knowledge, with enough updates on key areas of regulatory focus (off-label, patient assistance programs, state laws, etc.) to keep the seasoned compliance professionals in the audience satisfied with agenda. It also offers industry professionals a rare opportunity to meet face-to-face with their peers and hear best practices for strengthening their compliance cultures and reducing risk. I highly recommend the conference next year for chief compliance officers, specialists, managers, and anyone working in the life sciences compliance training industry. Kudos to CBI and all the presenters!

Thanks for reading.

Sean Murphy
Editor, PharmaCertify Compliance Training Insights Blog

“Dear Connie the Compliance Training Specialist” is back!

PharmaCertify Team , , , , , , , , , , ,

Welcome to this edition of “Dear Connie the Compliance Training Specialist,” where we answer questions about timely compliance topics and delve into the best training for reducing risk.

This week: raising knowledge retention at the next POA.

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Dear Connie,

During the compliance portion of our last Plan of Action meeting, I introduced several scenarios for group discussion with the hope of making the session more engaging. For the most part, I think it was more successful than just reviewing a slide deck (our usual approach), but not everyone was engaged and I’m not sure they’re going to remember the key points. Any suggestions for our next workshop?

Signed,

Bewildered in Bridgewater

Dear Bewildered,

Kudos to you for making the effort to move beyond the “PowerPoint Overload” approach to live compliance training. To engage the entire audience, I suggest you “gamify” the discussion and have everyone team up to solve scenario-based challenges. Research has shown that creating a competitive environment raises the retention of key lessons and makes the content stick with the learners.

Here are a few suggestions that can add a level of interactivity, even if the time allotted to compliance is limited:

Form Teams

Competition is more fun and learning is enhanced when groups of participants work together to solve the scenario. Instead of asking individuals in the audience to give their opinion, create teams of participants based on regions, products, or any number of qualifiers. To save time at the session, create the teams ahead of time, in the planning stage.

Add Activities

Don’t just ask the teams to present their best suggestions for a scenario. Add activities that stimulate cooperation within the team. For instance, you can employ a card-sort exercise with scenario “flashcards” the teams sort into two piles, e.g., “permissible” and “not permissible.”

Teams can also compete against one another to solve a scenario-based “mystery” using their understanding of compliance best practices and company policies. Provide clues (emails, call transcripts, receipts, and text messages) during the workshop or ahead of time via email.

The activities can be developed in analog (paper-based) form or electronically through an online gaming platform or outside vendor.

Keep Score

Enhance the competitive spirit even more with a leaderboard that you update manually or electronically. Display the board continuously during workshop, or only after each activity is completed. If you send out questions in the weeks before the workshop, tell the learners they get points for how quickly they respond and for accuracy. Add those scores to the leaderboard as well.

Remember the Debrief

Don’t forget to leave time to debrief the audience once the activities are completed. You need to make sure the nuances and “gray areas” are understood, and the participants understand which company policies to reference for on-going guidance around the topics that were covered.

These are just a few tactics for raising the retention rate and “making live compliance learning stick.” My friends here at the compliance training division of NXLevel Solutions have experience creating compliance workshops for a range of life sciences clients. Feel free to contact them at 609-483-6875 to hear more ideas.

Thanks for the great question!

Connie the Compliance Training Specialist

Compliance Trends 2018: Our Point of View

PharmaCertify Team , , , , , , , , , , , , , , , , ,

The festivities have ended and a shiny new year is upon us, so we are switching hats – from party to prognostication – to delve into what we see as the hot compliance topics and trends for 2018. Based on our reading of the enforcement tea leaves, several 2017 topics should remain at the forefront, but our prediction on the level of activity emanating from the OPDP has changed from last year. So if you’ve resolved to stay up-to-date on all the compliance news fit to blog this year, what better way to start than with this look ahead.

We expect funding for patient assistance organizations, which are charities that provide financial assistance to patients to help cover the cost of medications, to be a trending topic in 2018. In 2016, federal agencies started to focus on the topic and issued subpoenas related to support provided to these charities. In 2017, two companies entered into settlements with the government over that funding. The government considers the practice to be a violation of the Anti-Kickback Statute because the funding offsets the co-pay of patients who participate in government healthcare programs.

Donations to charities that assist with medication costs are permitted, but assistance cannot be directed to patients who are prescribed the donating company’s medications. We would not be surprised to see the government take more of an interest in the financial relationship between the industry and charitable patient organizations this year. Training must emphasize the need to maintain appropriate independence between the company and the patient organizations it chooses to support.

In 2017, a small group of states passed laws related to price reporting, sales representative registration, and physician payment caps. That trend should continue in 2018 and the laws will most likely be focused on pricing transparency, as opposed to spend transparency, which was more common a few years ago. Expect more states to follow New Jersey’s lead and implement broader restrictions and caps on payments to healthcare professionals. The law is intended to combat the growing opioid addiction crisis.

2017 was a surprising year for the Office of Prescription Drug Promotion (OPDP). After a flurry of letters at the end of 2016, we expected the agency to continue that trend into 2017, but only four letters were issued the entire year. That is a record low. Don’t expect a dramatic increase this year.

The letters that were issued last year were focused on false and misleading statements related to risk and omission of risk. Two industry settlements in 2017 included charges of failure to disclose risk in violation of the Risk Evaluation and Mitigation Strategy, so emphasizing the importance of fair balance and truthful, accurate promotional statements when training sales representatives is critical.

On the global front, we would not be surprised to see an uptick in Foreign Corrupt Practices Act enforcement following the implementation of new processes that reward companies for self-disclosing potential violations and cooperating with investigations.

With that, we end this “preview” edition of the Compliance News in Review. To be automatically notified when we post new editions of the News in Review, conference highlights, or compliance training tips, just click the “follow” button on the right side of this page.

Have a safe and compliant 2018!

The 2017 Compliance Year in Review!

PharmaCertify Team , , , , , , , , , , , , , , , , , , , , , , , , , , ,

As the year winds to a close, we take a break from the hustle and bustle of holiday preparations to reflect on the 2017 trends, topics, and focal points from the world of life sciences compliance. It’s been a busy year, with some expected updates, along with a few surprises, filling our News in Review missives from month to month. So, grab a cup of egg nog, fire up the Yule Log on YouTube, and enjoy this “year in review” edition of the Compliance News in Review.

Drug pricing transparency was a hot topic at the end of 2016, and the trend carried through 2017. The rules for Chicago’s new sales representative licensure law, which is intended to help combat opioid addiction, went into effect. The law requires representatives to obtain a license to sell products in the city and to document their interactions with healthcare professionals. In California, drug manufacturers must now notify the State and other payers in advance when they intend to raise the wholesale acquisition cost of a drug over a certain percentage, and when new drugs are expected to have a wholesale acquisition cost that exceeds the Medicare Part D specialty drug threshold. Nevada passed similar legislation, but its law focuses on diabetes drugs. Nevada also requires sales representatives to be licensed and provide reports of their interactions with HCPs. Finally, Louisiana also jumped on the pricing transparency train.

In an effort to combat the opioid crisis,  Governor Christie in New Jersey issued rules that cap payments made to healthcare professionals by pharmaceutical companies.  Maine passed a gift ban law similar to the existing Minnesota law and, not surprisingly, we heard from Vermont in 2017. The attorney general there is reportedly investigating whether drug and device companies are adhering to the state’s HCP gift ban law.

Not all state-level action was successful. Missouri’s proposed price transparency law did not pass during the past legislative session, and a bill in California to restrict gifts and payments to HCPs passed the state Senate, but was rejected in the Assembly.

Pharmaceutical support for patient assistance charities was another 2016 hot topic that continued through 2017.  An IRS investigation into one of the charities focused on whether it provided an improper benefit to pharmaceutical donors by using the donations to purchase the drugs manufactured by those same companies. Support of patient assistance charities also figured into one company’s healthcare fraud criminal and civil settlement with the government.

2017 was a quiet year for the Office of Prescription Drug Promotion (OPDP). During December of 2016, the agency dropped a flurry of letters, but 2017 will likely see record low in activity with only three letters being issued so far for the entire year.

This was an interesting year in bribery and corruption enforcement. It began with a bang in January as the Serious Fraud Office entered into its first major Deferred Prosecution Agreement. With a changing of the guard in the U.S., FCPA actions were more subdued, but the diagnostic test company, Alere, settled with the Securities and Exchange Commission over improper payments to foreign officials allegedly made by its Colombian and Indian subsidiaries.

The Department of Justice (DOJ) published its Compliance Program Evaluation Guidance in 2017. The document offers details on what the agency considers to be an effective compliance program. Perhaps most notably, the DOJ made its Foreign Corrupt Practices Act Pilot Program permanent. The pilot program ended in early 2017, but it was effectively made permanent with the announcement of a new FCPA Enforcement Policy. Like the pilot program, the new policy encourages companies to self-report possible FCPA violations and rewards companies for their  cooperation during investigations.

With that, we close out another issue of the Compliance News in Review, and another year in the wonderful world of life sciences compliance. We look forward to keeping you up-to-date on all compliance news fit to blog in 2017 and continuing to provide you with an ever-expanding suite of PharmaCertify compliance training products and services.

Thank you for reading. Have a warm and wonderful holiday season and a happy New Year!

18th Annual Pharmaceutical and Medical Device Compliance Congress: A Preview

PharmaCertify Team , , , , , , , , , , , , , , , , ,

PCF’s annual Pharmaceutical and Medical Device Compliance Congress kicks off next week. The conference offers attendees the rare opportunity to network with industry leaders and hear their thoughts and suggestions on the bevy of topics and regulations affecting those who work in the pharmaceutical or medical device compliance field. Narrowing the list of impressive panels and sessions down to a manageable schedule may seem overwhelming, but we’ve perused the agenda for what we are looking forward to the most:

Day 1, Monday November 6, 2017

Keynote: OIG Update
Hearing the list of topics that led to settlements and the OIG’s fiscal year 2017 workplan from Mary Riordan, Senior Counsel, Office of Inspector General, Department of Health and Human Services is always valuable for anyone responsible for rolling out compliance training. We are also looking forward to hearing how the agency expects to apply information from the Compliance Program Effectiveness Resource Guide released earlier this year as it conducts investigations.

U.S. Attorney’s Roundtable
While we expect to hear about topics such as off-label promotion, we look forward to hearing what the U.S. Attorneys say about the emerging trend of investigating manufacturer relationships with patient assistance charities. Several companies have been subpoenaed for information about these relationships. One company recently entered into a Deferred Prosecution Agreement, as well as a Corporate Integrity Agreement, after being accused of paying kickbacks to a patient assistance charity.

Chief Compliance Officer Roundtable
For those working in compliance for emerging companies, this session offers an opportunity to learn what risks their brethren from larger companies are facing so they know where to focus their priorities for the upcoming year. With Arjun Rajaratnam, from Smith & Nephew, joining the roundtable, medical device company representatives should also find the information worthwhile and relevant.

Day 2, Tuesday November 7, 2017

HCP Engagement: The Road to Proactive Risk Management

The title is intriguing and we’re curious to know what steps industry professionals like Tom Glavin of Olympus and Michelle Murphy of Regeneron utilize to change their corporate cultures and convince leadership to shift to a more proactive model for addressing risk.

Managed Market Considerations for Hub and Specialty Pharmacy Arrangements

Training and messaging for those who work with specialty pharmacies is a topic not often addressed in these forums, so hearing what industry professionals like Terra Buckley of Celgene and Greg Sherman of Gilead Sciences say should be of value.

Compliance Considerations for Small and Mid-Sized Pharma and Medical Device Companies

Here is a direct opportunity for attendees from emerging companies to evaluate their programs against companies of a comparable size and learn best practices for managing risks with less resources.

Brief Overview of the Policy and Politics of Pharma Pricing

Transparency around drug pricing is a hot topic with state and federal legislators. Learning more about the current laws, as well as what to expect from politicians in an election year, should prove to be valuable when evaluating risk, writing policy, and developing training.

The Exhibit Hall (Especially Booth #112!)

We’re looking forward to catching up with clients and friends (old and new) at the 18th Annual Pharmaceutical and Medical Device Compliance Congress. During the networking breaks, we invite you to stop by the PharmaCertify Booth to see demos of our newest compliance training solutions. Our mission is to help you build a stronger compliance culture and reduce risk, and we welcome the opportunity to show you how we’ve done just that for our clients. While you are there, don’t forget to enter the drawing to win a JBL Flip 4 Waterproof Portable Bluetooth Speaker!

See you in Washington!