Compliance News in Review, September 8, 2017

Attention students! This week in the news: an opioid marketing Warning Letter; more state level transparency requirementss; and Novo Nordisk learns a tough lesson about product marketing.

The wheels on the bus are going ‘round and ‘round for children all over the country. School is back in session. Time to sharpen those pencils (do kids still use pencils?) and organize that Trapper Keeper. Sorry kids, but we kind of like this time of the year. After all, the deals on office supplies can’t be beat! Can one ever have enough index cards and three prong folders? While we go bask in the glow of our school supply haul, we’ll leave you with a little reading assignment: the latest edition of the Compliance News in Review.

Opioid manufacturer, Cipher Pharmaceuticals, didn’t have a letter sent home by the teacher, but it was issued a Warning Letter by the Office of Prescription Drug Promotion for misbranding its drug, ConZip. The company licenses the drug to Vertical Pharmaceuticals for sales. The letter references a sales aid that failed to disclose the risks associated with use of the product.

Don’t offer the teacher too many of those apples…at least in New Jersey. In the Garden State, Governor Christie wants to place restrictions on transfers of value to HCPs. The regulation limits compensation for “bona fide” arrangements up to $10,000 per year. It requires the arrangements to be in writing, with the HCP’s qualifications clearly stated in the agreement. The regulation also prohibits receipt of lavish meals, gift cards, and other items of a personal benefit to HCPs. Exclusions are made for payments for speaking at CME events and provision of items for patient education. The regulation will be published to the New Jersey Register in early October and a public hearing is scheduled for October 19.

Two industry trade associations are putting their civics education to work. PhRMA and BIO have filed suit against Nevada over the state’s transparency law. The groups claim the law is unconstitutional, and is preempted by federal law, and they have asked the court to put a halt to the implementation or enforcement of what they consider to be the problematic parts of the law. A representative from BIO said the law effectively establishes price controls on diabetes medication, which in turn will reduce private investment in biomedical innovation. A PhRMA representative said the law is unconstitutional because it conflicts with federal and state laws that protect intellectual property and trade secrets.

The city of Chicago is jumping onboard the drug pricing transparency bus. An ordinance has been proposed that will require manufacturers to report price increases 90 days in advance of sales. The ordinance also proposes the establishment of a Prescription Drug Price Review Board to monitor prices, and a hotline for the public to report information about price increases.

Novo Nordisk agreed to pay over $58 million to settle allegations it violated the Food, Drug, and Cosmetic Act (FDCA) and the False Claims Act. According to the DOJ, sales representatives downplayed or mislead HCPs about the risk of a rare cancer associated with the use of Victoza when detailing the drug to healthcare professionals. The company will pay $12.5 million in disgorgement for violating the FDCA, and $48.5 million for violating the False Claims Act.

With that, the final bell rings on this edition of the News in Review. We hope the return to the post-Summer school routine is a smooth and seamless one for all involved. We’ll see you around the schoolyard during recess with another edition of the Compliance News in Review.

Compliance News in Review, May 22, 2017

Insider trading baseball; PhRMA changes the rules; shorter FCPA investigations; praise for Medicines Australia transparency efforts; and a Chinese television drama all about anticorruption. The heat is on in this edition of the Compliance News in Review.

The “official” start of summer is just around the corner and the sun, sand, and ‘squitos will be here before you can say “turn up the air conditioning.” Considering the late winter-like weather many have been experiencing around the U.S. (we feel your pain Colorado), a little heat and humidity sounds like a good idea. Before we restock the sunblock supply and head for the beach (or “down the shore” if you happen to reside in New Jersey), let’s review what has been heating up the newswires, with this issue of the Compliance News in Review.

A former “boy of summer” Doug DeCinces, was found guilty of insider trader for acting on non-public information related to the sale of a medical device company. Prosecutors claimed the former major league baseball player received information from his neighbor, the CEO of a medical device company, about the pending sale of the company to Abbott Laboratories. Prosecutors claimed DeCinces, who was found guilty on 14 felony counts, made stock trades based on the information and tipped others about the sale. His lawyer plans to file a motion for a new trial.

The heat is on at PhRMA. New rules regarding membership in the organization went into effect recently, and promptly led to the ouster of several companies. The new rules require member companies to spend at least 10% of sales on global research and development over three years. Companies must also spend at least $200 million a year on research. Seven companies were unable to meet the new requirements and lost their membership.

Some doctors felt the need to share their warm feelings for Medicines Australia’s transparency efforts. A pair of physicians, and the leader of the Greens party, who is also a doctor, penned a letter to the Australian Medical Journal, praising the organization’s move to increase transparency in industry/HCP relationships. The letter suggests that pharmaceutical and medical device companies follow Medicines Australia’s lead.

As the summer days grow longer, FCPA investigations could be getting shorter. During a conference, Trevor McFadden, acting principal deputy assistant attorney general, for the Department of Justice, expressed his hope that future FCPA investigations will “be measured in months, not years. FCPA thought leaders believe that narrowing the self-reporting window will help control the scope of investigations, but interviewing witnesses in foreign countries can be time consuming.

A television program focused on anti-corruption in government is heating up the Chinese airwaves. The Chinese government usually bans artistic endeavors related to anti-corruption, but the drama, In the Name of the People, has the support and “green-backing” of the government. The show follows the story of an upstanding detective who investigates government corruption in a fictional Chinese province. The program is the top show on Chinese television, and nearly a dozen similar programs are in production.

The focus on anticorruption efforts around the world continues to grow. Does your training extend beyond the FCPA to cover countries like China, Mexico, and Brazil? The newly update Compliance Foundations™ eLearning module, Global Anticorruption Laws introduces learners to the regulations, and the affect they have on their daily work lives and the pharmaceutical and medical device industries in general. Contact us to see a content outline or demo.

Thanks for reading!

Notes from A Busy Day at CBI’s 14th Annual Pharmaceutical Compliance Congress

The 14th Annual Pharmaceutical Compliance Congress featured an array of industry leaders, regulators, and legal consultants offering best practices, tips, and first-hand experiences related to reducing risk and strengthening compliance programs. This summary is focused on Day 1 of the conference, which featured a robust array of general sessions and breakout panels.

Pre-conference sessions were held the day before, and included Accelerated Learning — Healthcare Compliance and Policy Applications, which featured a panel of industry subject matter experts, including Dan O’Connor, Senior Vice President for PharmaCertify™, covering the topics those new to life science compliance need to understand in order to establish and maintain an effective program.

Luminary Session

The first presentation, Ignite and Infuse — Integrating a Compliant Culture within the Company’s DNA, featured three senior industry leaders, Beth Levine from Regeneron, Jim Massey of AstraZeneca, and Michael Shaw from GlaxoSmithKline offering compelling lessons on establishing successful compliance programs and the value of understanding “why they do what they do.”

Beth Levine shared the value principles she prioritized as she started building the department in 2008 when she was hired as the company’s first chief compliance officer. From the beginning, she emphasized the importance not having a “prosecutorial culture,” but one that was more “human, helpful, and empathetic.”

Jim Massey began his comments by recounting the recent United Airlines story related to the passenger being forcefully removed from a flight and the company’s public relations missteps in the immediate follow up. The core of the problem, as Massey saw it, was that United employees were strictly following rules and not making decisions for themselves.

At AstraZeneca, Massey and his team have instituted a true rules-based in which they “trust their people and not just the policies.” His goal was to simplify the policies as much as possible, so much so that the company now has a one-page Code of Conduct.

Michael Shaw followed in agreement, stating his belief that “complexity creates more risk rather than mitigating risk.” He used the example of speaker programs and the value of narrowing the policy down to kickback risks and communication risks.

The concept of a values-based approach to compliance has been discussed at length over the last ten years of the Pharmaceutical Compliance Congress, but this was the first time I heard the presenters offer such concrete and compelling examples and case studies of how their companies put the idea into practice. So much so that, throughout the day, other industry professionals and government regulators repeatedly referenced their comments to emphasize and highlight their own points. It was an illuminating presentation.

Elite Chief Compliance Officer Exchange and Fireside Chat

Next, compliance officers from Alexion Pharmaceuticals, Johnson & Johnson and Merck focused on data privacy and shared their thoughts on the proverbial question of “what keeps them awake at night.” For one presenter, that answer was tied to global risks (another common theme throughout the conference) and for another, it is more about the risks that “have not yet been identified” and that’s why regular risk assessments are so important. In a nod to representatives from smaller companies in the audience, that same presenter warned them not to over-engineer the risk assessments too much and to, “follow the money, and focus on the company’s business plan” to help identify the risks.

More than one presenter during the Fireside Chat stressed that while the data can be useful and powerful, “at the end of the day, it’s about respecting people’s privacy,” which relates to the values approached espoused in the first session. In the words of that CCO, “you need to think about what’s important, not just the process.” As another echoed, “don’t sit back and wait for laws and regulations, put in protections for providers and patients.”

U.S. Healthcare Fraud Enforcement Panel/Former Prosecutor’s Panel

The presentations shifted to the point of view of the industry as a panel of U.S. Attorneys took the stage for the Top Enforcement Trends and Focal Points for 2017 and Beyond session, which was blended with the former prosecutor’s panel, New Developments on High-Profile Cases and Settlements Uncovering Healthcare Fraud.

Unexpectedly, the discussion began with a sobering discussion about the opioid crisis in America, with disturbing statistics on the alarm growth of addiction rates and overdose deaths. It’s not a topic the audience necessarily expected, but it’s one that needs to be discussed, as regulators and the healthcare community seek answers to this frightening scourge that crosses all socioeconomic borders. The numbers are disturbing, and the panelists emphasized that “everyone is working together to figure out where the over-prescribing is coming from,” and “anyone involved in the distribution chain must have a program in place to help detect misuse and abuse.” They’re comments were punctuated by a reference to the recent McKesson case, in which the company paid $150 million to settle claims that it failed to put a system in place to detect suspicious orders.

A former US attorney offered a powerful suggestion when he called for the audience members to immediately and safely remove unused medications from their home, when they return from the conference, because “70% of people who start abusing opioids get them from someone they know, not a doctor.”

The two panels covered more traditional topics as well, and discussed the need for an active and strong compliance program. One presenter focused on smaller companies and warned of the risk of being too focused on being acquired to spent sufficient time on compliance. Not only is that a risk for the company itself, it should be a huge concern for any company interested in acquiring it. Another presenter touched on the familiar theme of “embedding yourself in the business,” as a method for ensuring the program is predictive and “risk-intelligent.”

The session closed with an important and hopeful comment from one panelist when he said, “what you don’t hear about are cases we decide not to prosecute because the companies have such robust compliance programs. That happens in all of our offices.”

Promotional Compliance

After the lunch break, I joined the Promotional Compliance content stream, which began with Tom Abrams of the Office of Office of Prescription Drug Promotion, and his annual Hot Topics, Guidance, Enforcement Trends, and Warning Letter Review session.

Tom detailed the recent Tuxarin ER warning, which focused on a series of troublesome product claims, including the suggestion that the product is safer than its competitors based on differences in dosing formulation and safety profiles of individual ingredients. He also provided a review of the recent Draft Guidance of Medical Product Communications That Are Consistent With the FDA-Required Labeling. The guidance explains the FDA’s current thinking on common questions about the topic and explains that the agency does not consider communications that are consistent with the FDA-required labeling to alone be evidence of a new intended use. A full list of recent warning letters and guidance documents are available on the FDA’s website.

During the First Amendment and Off-label – Caronia and Beyond presentation, Elizabeth Kim of Loeb and Loeb briefly touched on the history of the key cases over the years, and left the audience with key takeaways in terms of where we are now with off-label promotion as it relates to the First Amendment, including:

  • FDA will continue regulate promotion, and there is no green light to promote off-label;
  • Information can be truthful but still misleading in context, and;
  • Transparency and full disclosure are key and includes the good and the bad in terms of how you promote.

She also touched on the recent Arizona off-label law knows as the Free Speech in Medicine Act. At least one institution, the Goldwater Institute, wants to encourage other state legislatures to consider similar legislation, but the law is federally pre-empted, so at this point, it is a symbolic step.

Conclusion

The panel sessions and presentations covered above represent only a portion of the guidance and valuable information offered throughout this year’s Pharmaceutical Compliance Congress. The conference is always chock full of content applicable to those new to the field of life sciences compliance, as well as experienced professionals seeking the latest in best practices, suggestions, and guidance from their peers, consultants, and regulators. This year’s agenda and presenters did not disappoint.

Thanks for reading.

Sean Murphy, Product and Marketing Manager

Compliance News in Review, April 19, 2017

The city of Chicago releases sales representative licensure rules; review and dispute time is here again; opioid manufacturers receive letters and negotiate settlements; and Australia proposes changes to its bribery law, in this edition of the Compliance News in Review.

April showers may bring may flowers, but they also bring something else…the Boys of Summer. Major League baseball is back! Much of the buzz seems to center around a former Heisman Trophy winning quarterback and his homerun prowess. Whether your team is off to a hot start (we’re looking at you Yankees fans) or surprisingly struggling (are the Blue Jays already too far out?), there’s plenty of time for the standings to change as the temperatures warm. For now, buy me some peanuts and Cracker Jack and settle in for this edition of the Compliance News in Review.

Our first story comes from Chicago, home of the 2016 World Series champion Cubs. The City has released draft rules for its pharmaceutical sales representative licensure ordinance. The initial license is $750.00. Like the rules in place for detailers in Washington DC, Chicago’s ordinance has a continuing professional education provision. Education provided by the rep’s company will not suffice in meeting the requirement unless the company applies for and receives approval from the city. The draft rules also require sales representatives to track their interactions with healthcare professionals.

April 1st was opening day for the Open Payment’s review and dispute period. Physicians and teaching hospitals are free to review recent submissions to the system and dispute items they believe are incorrect. The review and dispute period for the 2016 Program Year ends on May 15th.

Senator Claire McCaskill sent letters to a lineup of opioid manufacturers requesting that they provide information related to sales, marketing and education strategies used to promote their products. from which she wants some information. McCaskill acknowledged that most of the players in the opioid market act responsibly and she said the purpose of her investigation is to learn if any of the practices

Mallinckrodt has agreed to settle a DEA probe for $35 million. The settlement involved the company’s suspicious order monitoring program for controlled substances. The settlement is under review by the DOJ and DEA. In a statement, Mallinckrodt said it had not violated the law, and the settlement does not include an admission of liability.

Australia appears to be poised to move its bribery law up to the major leagues. Government officials there announced that several reforms were being considered to deal with bribery of foreign public officials. The reforms include the addition of a “corporate failure to prevent bribery” offence and use of deferred prosecution agreements to encourage self-reporting. Among the changes proposed, the definition of a foreign public official would include political candidates and bribery offences would extend to those that offer a “personal advantage,” not just a “business advantage.”

The anticorruption landscape continues to evolve. The PharmaCertify Compliance Foundations™ eLearning module, Global Anticorruption Laws, covers the concepts common to most anticorruption/anti-bribery laws, as well as the specifics related to laws such as the FCPA and the UK Bribery Act. In addition, our new Compliance QuickTake™, Recognizing and Reducing Third-Party Risks, covers the risks associated with working with third parties, in a targeted microlearning format.

The PharmaCertify™ team will be offering demos of our compliance training products at the Pharmaceutical Compliance Congress in Washington next week. Stop by Booth 10 in the Exhibit Hall to say hi, and while you’re there, enter our drawing to win a JBL SPLASHPROOF PORTABLE SPEAKER.

See you in Washington!

Move Beyond the Basics to Make Compliance Training Stick

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

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

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

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

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

See you in Washington!

Sean Murphy, Product and Marketing Manager

The Forgetting Curve and Compliance Training

 

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

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

 

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

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

Micro-learning Tools

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

Code of Conduct

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

Keep it Continuous

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

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

Sean Murphy, Product and Marketing Manager, PharmaCertify™

Discount Registration: Pharmaceutical and Medical Compliance Congress

The 17th Annual Pharmaceutical and Medical Device Compliance Congress is scheduled for October 19-21 and the PharmaCertify team is looking forward to catching up with colleagues and sharing demos of our newest compliance training solutions. As a conference sponsor, we have the opportunity to offer you a $600 discount on the full conference registration cost. If you’re interested in taking advantage of this opportunity to hear industry professionals and government regulators discuss the latest guidance and share best practices, contact Dan O’Connor at doconnor@nxlevelsolutions.com.

If you can’t make it this time, don’t worry, we’ll be posting updates on the PharmaCertify Twitter feed, and a conference review on the our blog soon after the conference closes.

Thanks for reading and stay compliant!