11 Key Takeaways from the 3rd Annual Life Science Compliance Training Conference

Last week, we sponsored Q1 Production’s 3rd Annual Life Science Compliance Training Conference, where a highly-energized group of compliance training leaders from the pharmaceutical and medical device industries shared their ideas and techniques for making compliance training more engaging, creative and effective.

Here are my key takeaways from two great days of presentations and spirited conversation:

1. Less is more.
The idea of shorter, higher-impact training was reiterated throughout the conference and was a common theme across the presentations. One presenter said her company now limits all compliance training to 15 minutes and another said her company “hasn’t rolled out training longer than 15 minutes in two years.”

2. Remember the tone from the middle.
While “tone from the top” has been a point of emphasis in the industry for a long time, “tone from the middle” was cited as a key in multiple sessions in Chicago. “The immediate manager has to understand the message,” one presenter said, “that is who the people in the field are going to hear the message from.”

3. Communication is training too.
As one presenter put it, “anytime we can connect with an employee with something they can takeaway, it’s training.” Companies are using a variety of methods to make that connection, ranging from quick reminders via email, to video clips, resource websites, and graphic comic novels. Think outside the box and look for continuous touch points.

4. Tell a good story.
Research shows that well written stories improve learning and increase retention of critical compliance content and policies. The quality of the writing is the key. Once you find a good writer, have him or her create a story arc and develop a narrative. To save on budget in the production, use illustration instead of video. It’s less complex. The quality of the writing is as important, if not more important, than the nature of the medium.

5. Measure the metrics.
Data is important and even the “soft” metrics like feedback from the learners and the managers, testing results, changes in audit data, and increases in hotline reports, are important when identifying what curriculum adjustments are necessary. Data is important, so much so that one presenter noted that she recently hired a “data analytics person” to see what else they can learn.

6. The principles-based approach to compliance is here to stay.
The principles-based approach to compliance was introduced years ago and it has clearly become a trend in the life science industry. Multiple presenters discussed the need to empower personnel with the ability to make decisions, rather than just training on the rules. As one presenter put it, “let them make their decisions about what is the right thing to do, and let them know where to get the answers if they are uncomfortable making the decisions.”

7. GXP compliance training requires a different approach.
This one was a surprise and was raised in response to questions from the audience. Several presenters noted that they are also responsible for GXP compliance training and the nature of the content and the expectations of the learners require a much more traditional approach to training. Essentially, a rules-based approach is much more necessary when dealing with manufacturing compliance.

8. Create a brand.
To quote one presenter, “companies spend millions of dollars branding products, so why not brand compliance training?” Branding gives you more opportunities to creatively communicate the key concepts and messaging. Brand the policies and the principles to create a coordinated and clear message.

9. One size does not fit all.
When developing compliance training, keep the learner’s application of the content in mind. In other words, make it relevant to the learners. Use scenarios that reflect risks they are likely to encounter. As one presenter stated, “training needs to be risk-based, and you need to train on the topics that are core to your business.”

10. Relationships count.
Getting stakeholder buy in on the training at every stage (development/delivery/completion) is critical. Don’t just focus on the proverbial seat at the table with upper management, develop relationships across the company, and seek feedback from the business groups, sales managers, and sales training.

11. And finally, beware of the speaker programs!
When evaluating risks, make those speaker programs a priority.

Kudos to Q1 productions, the presenters, and everyone involved in the 3rd Annual Life Science Compliance Training Conference. From the opening audience ice-breaker, to the closing session, it was one of the most informative, focused, and engaging conferences I have attended in ten years of working in life science compliance.

I look forward to next year’s conference and I highly recommend it to anyone interested in sharing ideas and hearing what others in the industry are doing to make their curricula more engaging and more effective.

Thanks for reading!

Sean Murphy
Product and Marketing Manager
PharmaCertify by NXLevel Solutions

The 3rd Annual Life Science Compliance Training Conference: A Preview

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The 3rd Annual Life Science Compliance Training Conference opens Wednesday, June 6, 2018  at the Hilton Garden Inn in Chicago. The PharmaCertify team will be there to catch up with clients and colleagues, and share demos of our newest compliance training solutions. I also always welcome the opportunity to hear from those who are directly responsible for building and maintaining a modern and effective compliance curriculum. It’s always an enlightening experience. Here are a few presentations I am looking forward to in particular:

Day One

Structure and Delivery of Compliance Content for Executive Level

After opening remarks from PharmaCertify’s own Dan O’Connor, who is chairing Day One, the conference begins with this compelling panel presentation. Recent enforcement headlines, and an increasing number of presentations by regulators at large compliance congresses, highlight the importance of training C-Suite executives in compliance. But what topics are most critical and what tools are most effective? I am anxious to hear what delivery and engagement tools the presenter’s company uses to help support and encourage a strong “tone from the top” as part of the effort to build a stronger compliance culture throughout the organization.

Adapting Compliance Training Methods and Materials Based on Evaluated Risk
Gary Mendelsohn, Astellas

Data is trending for good reason. The data gained through extensive auditing and monitoring is an important tool for evaluating whether compliance training methods and content need to be modified to better address organizational risks. This is a timely topic as life sciences companies continue to look to the data for answers on how to better target their training.

Alignment of Compliance Training with Current Areas of Inspection
Kelly Tope, Zimmer Biomet

A medical device perspective on compliance training is always welcome in compliance conferences. While dealing with some of the same challenges of their pharmaceutical counterparts, medical device professionals face unique challenges due to the nature of their HCP interactions and reimbursement arrangements. This session should provide helpful information for both sides of the life sciences fence, as common and industry-specific settlements are reviewed for training topic relevance.

Case Study: Providing Employees Access to Performance and Development Resources
Jackie Bauer and Stacey Leonard, Abbvie

When evaluating a compliance conference agenda, my eyes are always drawn to the words, “case study.” Attendees are there to hear what techniques, programs, and tools work for their peers and case studies offer the best framework for doing so. With the phrase “continuous learning” in this session description, my interest is piqued even more by the potential for learning what tools and materials the presenter deploys on a regular basis to enhance learning and increase retention of key content.

Day Two

Panel: Building Employee Accountability to Support Compliance Training
Kim Ingham, Merck, Sharon Delgado, Orexigen Therapeutics Inc., Susan Novak, Celgene

Industry professionals have been espousing the importance of a “culture of compliance” for about as long as compliance has been a focus for the life sciences. By contrast, a “culture of accountability” is a term I have not seen applied to the compliance space, and at first glance opens the door for exciting possibilities. This session promises “varied perspectives on how to build and engage staff in heightened levels of accountability,” and I am excited to hear what strategies the presenters utilize to encourage accountability across each of their three companies.

Advanced Adult-Learning Practices for Heightened Engagement in Compliance Training
Abby Talanca, Johnson & Johnson

As compliance training tools have advanced, on-going research into adult learning practices has led to the utilization of more effective development methods and delivery mechanisms to enhance learning. Based on the agenda description for this presentation, I will be curious to hear exactly how the Johnson & Johnson compliance team integrates modern methods like continuous learning into their curriculum to increase retention and maximize on-the-job application of the knowledge gained through the training.

Train the Trainer Workshop: Increasing Connection & Retention in Compliance Training
Mona Kay Gorman, Valeritas

Compliance training curriculums are often developed with an understandable focus on internal stakeholders and with a lack of attention paid to the internal trainers – those responsible for delivering the training. Mona Kay Gorman brings extensive experience delivering engaging live compliance training, and hearing her suggestions for how to improve the skills of trainers so workshops and courses are more engaging and effective should prove valuable and worthwhile.

Proactive Approach to Analyzing Compliance Data for Preventative Training
Kevin Ryan, Novo Nordisk

Extending the topic data analysis to the second day, the description for this session promises a review of the data sources available to compliance teams, and how to use that data once its collected to conduct gap analysis studies, and identify trends and potential compliance risks. Data collection and analysis offers forward-thinking compliance training professionals a critical tool for identifying trends and potential risks, then using that information to target training and segmenting trainee groups more accurately. It’s an important and timely presentation.

Next Stop: Chicago

The agenda for the 3rd Annual Compliance Training Conference offers a great lineup of industry professionals sharing the latest in training best practices, suggestions, and tips. If you’re attending, stop by the PharmaCertify booth in between sessions to see demos of our newest compliance training solutions. If you can’t attend this year, watch for my blog post with conference highlights right here on the Compliance Training Insights Blog shortly after we return.

Thanks for reading!

Sean Murphy
Product and Marketing Manager
PharmaCertify by NXLevel Solutions

News and Notes from the 15th Annual Pharmaceutical Compliance Congress

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

The 2017 Compliance Year in Review!

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!

One company seeks to negotiate a settlement with the several states over opioid marketing, while Vermont investigates violations of its gift ban regulation…in this edition of Compliance News in Review.

Will Purdue Pharma go for the Hail Mary? Is Vermont about to throw a flag for gift ban violations? Is there a new way to offset bribery penalties? Will there be a third down push from the OPDP? We address these questions and more, in this edition of the Compliance News in Review.

In the words of Max from Where the Wild Things Are, “let the wild rumpus start.” No, not the holiday shopping frenzy (although that certainly applies), but the college football conference championships! Championship weekend is upon us and with it, the fight for a position in the playoffs. So far, the season has had its share of twists and turns, and the conference championships should provide additional drama. It all ends with the selection of the four playoff teams on December 3rd. To help fill the time to kickoff, we offer “X’s” and “O’s” of our own, in this edition of the Compliance News in Review.

Has Purdue Pharma huddled up with several state attorneys general? According to people familiar with the situation, the company has reached out to the states to gauge their interest in a global settlement related to its opioid drug. Currently, a consortium of 41 state attorneys general are investigating several opioid manufacturers’ marketing and sales practices. While Purdue is not authorized to represent other opioid makers, those familiar with the situation say the company is seeking an agreement that would cover all states’ lawsuits against all opioid manufacturers.

Vermont is calling for a review. The Vermont attorney general is investigating possible violations of the state’s gift to healthcare professionals ban according to a source familiar with the matter. The state law bans the provision of most items of value to healthcare providers. However, Open Payment data shows that physicians are receiving gifts, travel, and other banned transfers of value.

Companies that cooperate in FCPA investigations will now score big points with the Department of Justice. The agency will now consider foregoing criminal charges when a company self-reports. If a company cooperates with prosecutors, fixes the issue that led to the investigation, and helps investigators find the individuals responsible for the misconduct, the DOJ will presume the issue can be resolved without criminal charges. Any profits received from the misconduct will still need to be forfeited. Companies that do not voluntarily report possible FCPA violations may still be eligible for some leniency if they cooperate with investigators.

The Office of Prescription Drug Promotion has issued its third violation letter for 2017. A warning letter was issued to Amherst Pharmaceuticals and Magna Pharmaceuticals over promotional statements related to an insomnia drug. The OPDP cited false or misleading information about the risks and efficacy of the drug found on a product webpage and an exhibit panel. The letter also stated that the companies failed to submit the webpage and exhibit panels to the FDA prior to them being first used, as is required. Magna Pharmaceuticals says it will correct the exhibit panels and make sure all materials in the marketplace are correct. Amherst Pharmaceuticals was cited for information on the product webpage, but sold the insomnia drug to Magna in May.

With that news from the OPDP, the clock is winding down on this conference championship edition of the Compliance News in Review. If you’ve got a Dawg (how’s that for a hint as to who we will be pulling for?) in the fight in this weekend’s conference championships, we wish you luck (unless of course, your “Dawg” is a Tiger). Good luck to your favorite team or alma mater and we’ll see you here for the next edition.

Thanks for reading!

Open Payments Funding and Another Kickback Case in the News

An Open Payments letter from two senators, a list of diabetes drugs from Nevada, near silence from the Office of Prescription Drug and Promotion (OPDP), and an unsealed kickback case…all in this edition of the Compliance News in Review.

Thanksgiving is just around the corner! There’s nothing like a day of food, family, friends, and parades (and of course, football!) to kick off the holiday season. Can’t you just smell the turkey and fixings permeating the hallways and your olfactory senses now? Before we go unpack our “Thanksgiving pants,” we’ll leave you with a different type of tasty morsel: a new edition of the Compliance News in Review. Bon appetit!

Senators Richard Blumenthal and Chuck Grassley don’t want to see CMS’s Center for Program Integrity (CPI) left at the kids’ table. They sent a letter to the acting Health and Human Services Secretary urging that funding for the CPI be made a priority. The CPI is responsible for managing the Open Payments database. The letter includes references to “recent reports that have raised concerns about the effect payments to health professionals may have on opioid prescribing practices, which in many ways has exacerbated this ongoing public health epidemic.”

Nevada’s Department of Health and Human Services published its list of three dozen diabetes drugs that are subject to the State’s new transparency law. Manufacturers with a drug on the list will have to report a variety of financial information, including costs associated with production the drug; rebates and coups offered; and profits earned from the drug. Regulations for reporting the information are still pending.

Will the OPDP pass on dessert at Thanksgiving Dinner? OPDP is on pace to issue a record low number of letters this year. So far, only two letters have been issued. In 2016, the agency issued five in the first six months, then in December, it issued six more. The letter count has steadily declined over the last sixteen years. Will 2017 will be a record low?

On the social media front, Twitter upped its character limit to 280, and according to social media manager, Andrew Grojean, pharmaceutical marketers should take advantage of the expanded word count. Grojean says the change does not solve all the issues related to use of the platform, but it provides more freedom and flexibility, as well as more space for the required fair balance.

Did Eli Lilly over stuff the turkey? A recently unsealed whistle blower case alleges that the company provided kickbacks to boost sales of its drugs. According to the suit, the company offered nursing services to HCPs through a third-party to induce doctors to prescribe three of its drugs. Allegedly, the nurses essentially acted as sales reps even though they were supposed to be providing independent medical advice and disease state education.

With that, we end this holiday edition of the Compliance News in Review. In the spirit of the season, we are thankful to all who take the time to read our tome on a regular basis, and as always, we invite you to contact our editor, Sean Murphy, with your feedback. He can be reached at smurphy@nxlevelsolutions.com.

Have a fun and festive Thanksgiving holiday!

The Los Angeles City Attorney opens an investigation against one pharmaceutical company, while the founder of another is indicted on federal racketeering charges.

This year’s World Series brought record-setting excitement and late nights (more like wee hours of the morning for those of us in the East) for fans of America’s game. Congratulations to the Houston Astros, who outlasted the Los Angeles Dodgers, in a seven-game extravaganza, just as Sports Illustrated predicted…three years in advance!

If you’re searching for a new pastime to fill the void left by passing of another season, we have just the ticket. Step into the batter’s box as we present all the life sciences compliance news fit to blog, with this edition of the Compliance News in Review.

Leading off this week, a Wisconsin state legislator introduced a bill that will require drug manufacturers to notify the state in advance if they plans to increase the price of a drug by more than 25%. The lawmaker cited the costs to Medicaid budgets and a lack of transparency with consumers as the justification for the bill.

There’s no “Dodging” the Los Angeles City Attorney for Avanir Pharmaceuticals. On the heels of a CNN report, the City Attorney announced that he intends to open an investigation into the company’s prescribing practices for elderly patients in nursing homes. The report pointed to a rise in prescriptions for the drug in question, even though the studies supporting use with elderly patients are lacking. Top prescribers allegedly received speaking and consulting payments from the company.

Canada is pulling facilitation payments from the mound. The Canadian government announced it will repeal the exception for facilitation payments from its Corruption of Foreign Public Officials Act. The repeal was effective October 31. The law had previously permitted payment to expedite routine services, such as obtaining permits and scheduling inspections.

In news from overseas, the Prescription Medicines Code of Practice Authority (PMCPA), the group responsible for overseeing adherence to the Association of the British Pharmaceutical Industry’s Code of Practice (APBI), saw a rise of more than 40% in the number of complaints it received in 2016 about marketing and promotional practices. The complaints led to 100 new cases, with more than half of those resulting in the determination that the Code was breached.

Insys is on the losing end of a doubleheader, with the founder being indicted on federal charges and a New Jersey doctor potentially losing his license for allegedly accepting kickbacks from the company. The founder was indicted on charges of racketeering, conspiracy to violate the Anti-Kickback Statute, and conspiracy to commit mail and wire fraud. The company has been accused of promoting its opioid product for off-label uses and paying kickbacks to healthcare professionals.

The attorney for the New Jersey doctor says his client has never been the subject of a disciplinary hearing, or had a patient complaint in 25 years of practice, and he welcomes the chance to present his case to the medical board.

Speaking of New Jersey, a public hearing was held to receive feedback on the state’s pending regulation, “Limitations on Obligations Associated with Acceptance of Compensation from Pharmaceutical Manufacturers by Prescribers.” The regulation, which was announced by Governor Christie in late summer, includes restrictions related to transfers of value to prescribers of prescription drugs.  Many of the groups in attendance have expressed concern that the regulation’s $10,000 per year cap on bona fide services payments would have unintended consequences on clinical research. The New Jersey Attorney General stated that while some revision is possible, the State is committed to moving forward with the regulation. Public comments will be accepted through December 1.

With that, we end this “boys of summer (and well into fall)” edition of the Compliance News in Review. One final note: if you’re attending the 18th Annual Pharmaceutical and Medical Device Compliance Congress in Washington DC, November 6-8, stop by Booth 112 (back by all the good food!) to see demos of our newest compliance training solutions and the Compliance 365 Continuous Learning System.

See you in Washington!