Compliance Congress

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

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , ,

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

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

CCO Roundtable

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

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

FCPA Enforcement

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

Anti-bribery

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

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

First Amendment Update

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

Managed Markets

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

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

Compliance Training

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

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

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

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

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

Compliance 2.0

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

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

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

Beyond Transparency

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

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

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

The Evolution of Compliance Programs

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

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

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

Summary

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

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

Thanks for reading and stay compliant!

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

Compliance News in Review, October 14, 2016

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , ,

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

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

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

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

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

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

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

Thanks for reading and stay compliant!

The Pharmaceutical and Medical Device Compliance Congress: A Preview

NXLevel Compliance Team , , , , , , , , , , , , , , , , ,

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

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

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

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

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

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

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

See you in Washington and stay compliant!

Discount Registration: Pharmaceutical and Medical Compliance Congress

NXLevel Compliance Team , , , , , , , , , , , , ,

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!

 

Compliance News in Review, September 15, 2016

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , , ,

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

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

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

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

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

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

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

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

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

Until next time, stay compliant and enjoy the games!

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

NXLevel Compliance Team , , , , , , , , , , , ,

by Lauren Barnett

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

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

Don’t Forget the WIIFM

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

The Landscape Might Change 

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

Leave Time for the Gray Areas

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

Make it Stick

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

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

Excel for Tracking Training? Been There, Done That, and Sadly, I Have the T-Shirt.

NXLevel Compliance Team , , , , , , , , , , , , , , ,

As someone who worked in compliance for a small life sciences company, I like to share the problems and pitfalls I experienced over the years, in the hope of saving others from the same fate. Today, we touch on the subject of Learning Management Systems and in particular, my hard-learned lesson about trying to use Microsoft Excel for some LMS functions. I like Excel as a software program overall. And, if you work in training, it may seem like a logical choice for measuring metrics. It’s not. If your company doesn’t have an enterprise-wide LMS in place, or if a particular group of learners (e.g., third-party vendors) doesn’t have access to your internal LMS, I strongly recommend using a hosted or cloud-based LMS  rather than relying on Excel to handle the tracking and reporting.

Is an LMS a Better Option?

The obvious and primary limitation of using Excel is you still need to find a way to host and deploy the training. Even when used solely for the purposes of tracking and reporting, it can be burdensome, error-prone, and time-consuming. At a minimum, you need to enter all of the learner-related data, as well as the list of courses assigned to each learner, and the dates the courses were deployed and completed. Then there’s the on-going need to keep your learners updated with reminders that training is due, and the work necessary to pull metrics from all the data. Using Excel is a manual process, which opens the door for mistakes and those mistakes, are hard to catch when you’re pouring over hundreds of lines of data.

Using a hosted or cloud-based LMS helps automate those processes, greatly improves accuracy, and lightens the burden of the on-going work. While some upfront work is necessary as an administrator, the LMS itself does most of the heavy lifting. Deployment of the training and management of the completion records are handled by the LMS, freeing you from developing formulas and creating your own reports. In fact, you’re likely to get far more insight from the reports and metrics that are standard with most hosted and cloud-based services than you’d ever be able to pull from Excel. And the best part – all of this comes with the ability to host and deploy the training.

Of course, a hosted LMS solution isn’t the panacea to all of your workload challenges. You may not be able to customize the functionality of the LMS, and depending on what service you choose, you may or may not be able to manage your classroom learning with the service. Then, of course, there’s the big elephant in the room, the cost. Reconciling the budget when you think you can manage with the software you already have in house may seem difficult, especially for small to mid-size companies. However, when you factor in the time spent by managing all the tasks manually, the cost may not seem so overwhelming.

What About the Budget?

A number of cost-effective options are available. For example, our PharmaCertify Access™ LMS offers an affordable way for small to mid-size (and even larger) clients to host and track online training, whether it’s developed by us, another vendor, or in-house by our client.

Looking back on that Excel experience, I regret not giving more than a fleeting thought to using a hosted LMS, even though I only had a few hundred learners to manage. I’m sure an LMS would have provided better insight into the impact the training had on the audience, and would have allowed me to dedicate more time and resources to building an even better compliance training curriculum.

Thanks for reading, and stay compliant!

Lauren Barnett
Compliance Content Specialist
PharmaCertify™ by NXLevel Solution

 

 

 

Compliance News in Review, July 14, 2016

NXLevel Compliance Team , , , , , , , , , , , , , , , , , , , , ,

The Serious Fraud Office has its second application for a DPA approved, CMS solicits feedback, and experts are dismissed from an advisory panel due to perceived conflicts.

It’s hot, it’s humid, and the editorial staff at the New Jersey AND Georgia offices of the Compliance News in Review is already desperately seeking safety from the sun’s intense rays. The dog days of summer have arrived with gusto. If you’re looking for a good reason to spend a few more minutes in the comfortable confines of an air conditioned office or home, we suggest a deep dive into the cool waters of this edition of the CNIR, and all of the compliance news fit to blog.

Deferred Prosecution Agreements (DPAs) seem to be no sweat for the Serious Fraud Office (SFO). The agency has had its second application for a DPA approved in a case that involves violations of the UK Bribery Act. The company involved agreed to pay $8.48 million in fines and disgorgement. It must also report annually on its third-party intermediary transactions and compliance programs, and continue to cooperate with the SFO. The DPA remains in effect until 2020, but it may be terminated in 2018 if the company meets its financial obligations by then.

The Centers for Medicare and Medicaid Services (CMS) is basking in the Sunshine these days. In the proposed 2017 Physician Fee schedule, the agency solicited feedback for a number of questions related to the Open Payments program. The questions cover record retention, issues related to teaching hospitals, and the nature of payment categorization. Of particular note, the agency is seeking feedback about the benefits of pre-vetting payments with covered recipients and issues related to uploading data to Open Payments.

In an indication that their relationships with industry were a little too hot to handle, several experts have been removed from a panel that is responsible for advising the FDA about painkillers. The panel was created by the National Academies of Science, Engineering and Medicine, a larger advisory group to the FDA. The removal of the panel members appears to have been spurred by a letter Senator Ron Wyden sent to the Academy of Medicine complaining that some panelists had received support (in the form of grants) from pharmaceutical companies. One panelist, Dr. Mary Lynn McPherson, says the support in question did not go to her directly, it went to the university where she is on staff, and was in the form of unrestricted grants so the pharmaceutical companies never had input on how the money was used. Another of the dismissed panelists, Dr. Gregory Terman, says he was removed because the nonprofit group he heads received funding from several pharmaceutical companies. Terman says his association with the nonprofit was well known, and he has gone out of his way to avoid conflicts of interest.

The last story serves as a reminder that much of the data regarding the relationship between healthcare professionals and the industry is presented with little context as to the nature and reasons for the payments. HCPs are understandably sensitive about receiving certain transfers of value, and they have questions about how those TOVs are disclosed. Your transparency training should remind learners that they need to be sensitive about these concerns, and educate them on the proper protocol for addressing HCP questions about data.

With that, we close this mid-summer edition of the Compliance News in Review. Stay compliant and stay cool.

Compliance News in Review, July 5, 2016

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Another organization calls for a ban on Direct to Consumer advertising, two former industry sales reps are arrested for kickbacks, a former executive is acquitted on kickback charges, and CMS releases update TOV data.

Strike up the band and light up the fireworks! The American Experiment marked its 240th year this weekend. So, it’s fitting that the hottest ticket on Broadway these days is the story of one our nation’s founders. Since most of us won’t be lucky enough (or rich enough) to score tickets to Hamilton in celebration , we had to stick with the old standbys of parades, barbecues, fireworks. To cap the holiday weekend, we offer a new tradition to add to the list, the Independence Day edition of the Compliance News in Review.

The fireworks continue regarding DTC advertising. The American Society of Health-System Pharmacists is the latest group to express a desire to see DTC advertising of prescription drugs banned. In the past, the organization has been supportive of the advertising, as long as it meets certain criteria. Since it now believes the industry is ignoring the criteria, the group has withdrawn its support. A spokesperson says a complete ban is not possible, but he hopes this action will lead to a discussion between industry and healthcare providers about DTC ads. The current model of DTC advertising is outdated according to the spokesperson, and pharmacists and providers are spending too much time explaining to patients why drugs they see in ads are not appropriate for them.

A pair of former Insys sales representatives could be losing their independence in the near future. The two were arrested for allegedly paying over $250,000 in kickbacks to doctors who wrote prescriptions for the painkiller fentanyl. The complaint alleges that most of the money was paid for serving as speakers at programs that were essentially social functions. Very little, if any, educational information was shared, according to the complaint, and following the programs, the sales reps would often take the doctors out for drinks and other entertainment. In a statement, the company says the sales reps were no longer employed and company policy prohibits the giving of cash or other items of value as inducements for writing prescriptions.

It was no tea party in Boston for the feds in a case against a former Warner-Chilcott executive. W. Carl Reichel was acquitted of charges that he paid kickbacks to doctors. Prosecutors charged that the former executive created a strategy of paying kickbacks to doctors in the form of sham speaking fees, money, and free meals in exchange for writing prescriptions of Warner-Chilcott drugs. US Attorney Carmen Ortiz said the charges against Mr. Reichel were warranted, and while cases against executives are difficult to prove, they’re necessary to deter improper conduct.

CMS sent out its annual declaration about Open Payments data. The payment and transfer of value data has been published, and is now publicly accessible. This year’s data represents nearly 12 million records covering $7.52 billion paid to physicians and teaching hospitals. As usual, research payments account for the largest share of the total amount.

This edition of the News in Review reminds us that the consequences of non-compliant behavior can be quite personal. When the big headlines tend to be about the multi-million and multi-billion dollar settlements paid to settle charges of fraud and non-compliance, convincing individuals that there is also a price to pay can be challenging. Citing cases like these in your training is one way to inform commercial staff and executives of those consequences.

While we don’t advocate turning compliance training into something akin to “Scared Straight,” sharing the full landscape of government enforcement actions is important. This is especially true following last year’s memo from Deputy Attorney General Sally Yates about the DOJ’s emphasis on holding individuals accountable in cases of corporate wrongdoing.

That’s it for this edition of the Compliance News in Review. Stay compliant!

News in Review, June 15, 2016

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Federal investigators subpoena information related to charitable organizations from three companies, Congress proposes an amendment to the FDCA, the head of the FDA speaks on off-label information, and New Hampshire’s Attorney General targets the manufacturer of a popular painkiller.

The temperatures are rising well past 70 degrees Fahrenheit and that can only mean one thing…time to hit the beach! Pack up the station wagon, minivan, or whatever mode of transportation best accommodates your gear and head to the sand and surf for some fun and relief from the heat! Of course, the standard precautions and warnings are in order: use plenty of sunscreen; mind the flags regarding ocean conditions; and above all, be wary of teens resembling Frankie Avalon and Annette Funicello bursting into fits of random dancing and singing (now there’s a dated reference for you). Of course, you’ll need plenty of reading material before you drift off into a coconut oil scented daydream. So after you finish the latest from Mary Higgins Clarke or that true crime tome, please enjoy the next best beach read…this edition of the Compliance New in Review.

The waves of compliance just got slightly chopping for a trio of drug manufacturers. Three companies, Gilead, Jazz and Biogen, received subpoenas from federal investigators for information related to their relationships with charitable organizations that help patients with medication costs. Charities receiving support from industry companies claim those companies have no say or influence on which patients they help or what drugs are covered. The government’s concern centers on whether the contributions are essentially illegal kickbacks.

Oh sunny day – a panel of the House of Representatives Energy and Commerce Committee proposed an amendment to the Food, Drug and Cosmetics Act that would allow companies more leeway in sharing truthful off-label information. The proposed amendment would limit the definition of intended use to the manufacturer’s “objective intent,” and allow for the dissemination of materials for scientific exchange, if the information in the materials is backed by scientific evidence. The panel expressed concern about the need for doctors to be kept abreast of the latest medical information, and frustration at the lack of movement by the FDA on guidance related to the dissemination of off-label information.

The head of the FDA also rode the off-label promotion wave when he spoke at the BIO International Convention. In his remarks, Robert Califf noted that supportable information worth sharing should be included on the product’s label, and he questioned why companies would not include useful information on the label or in the prescribing information. Califf also encouraged the industry to embrace social media, saying, “the best way to develop products in the future is likely going to involve a lot of people with diseases to have a handle on what their needs are, what their expectations are, and what their risk tolerance may be.”

As expected, Vermont was first in the water with a law requiring transparency of drug pricing. State officials will identify 15 drugs for which they want information about the reasons for price increases. The manufacturers of those drugs will have to submit information to justify the price increases.

New Hampshire Attorney General’s office has filed suit against Purdue over the company’s refusal to provide documents related to the marketing of OxyContin. The AG’s office claims the company is providing HCPs with misleading information regarding the product. The suit claims the company touts the drug lasts for 12 hours, and it also does not appropriately address end-of-dose failure. The AG also claims the company downplays the risks associated with addiction. Purdue says it is more than willing to cooperate with the investigation, provided the AG’s office does not share any documentation with private attorneys. The company believes a financial conflict of interest exists with the firm retained to assist in the investigation, and it should not be compelled to turn over information while a court case is pending.

A report from Reuters questions the independence of firms hired by companies under a CIA to serve as an Independent Review Organization (IRO). Unlike other agencies, the Department of Health and Human Services does not prohibit companies under a CIA from hiring an IRO with which they have an existing relationship. Critics claim those arrangements represent a conflict of interest. A representative of the HHS Office of Inspector General (OIG) said she has not witnessed any issues with these arrangements. Spokespersons for various industry companies said they disclose all their business relationships to the OIG in advance.

The seas have also been choppy for Salix Pharmaceuticals recently. The company agreed to pay $54 million to settle allegations it provided kickbacks to physicians for prescribing its products. According to the DOJ, the company admitted to paying doctors to be speakers for the company as an inducement for prescribing its products. The government claims the programs at which the doctors spoke were largely social in nature and provided little or no information related to a product. In addition to resolving the federal case, the settlement will resolve several related state fraud cases.

That’s all for this edition of the News in Review. Until next time, we wish you safe sailing and calm compliance waters!