FCPA

Compliance News in Review, October 14, 2016

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

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

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

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

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

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

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

Thanks for reading and stay compliant!

The Pharmaceutical and Medical Device Compliance Congress: A Preview

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

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

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

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

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

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

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

See you in Washington and stay compliant!

Compliance News in Review, September 15, 2016

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

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

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

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

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

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

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

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

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

Until next time, stay compliant and enjoy the games!

Compliance News in Review, July 26, 2016

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Executives on trial, an FCA settlement, a “clarification” to a change in the District of Columbia detailer law, and an Open Payments open forum…all in this edition of the Compliance News in Review.

What do Teddy Roosevelt, Rob Lowe, and a chair have in common? They have all provided some rather famous, if not infamous, moments at the national conventions of the Democratic and Republican parties. Part pep rally, part three-ring circus, and part critical component in the fabric of this great democracy, the conventions are underway, and they have certainly provided entertaining television during the doldrums of summer. If your senses need a break from the constant barrage of politicking and speechmaking, let us gavel in all compliance news fit to blog, with this edition of the Compliance News in Review.

Guilty or not guilty? It was a little bit of both for two executives from Acclarent, who were on trial for selling misbranded and adulterated medical devices. The jury found the pair guilty of misdemeanor charges distributing misbranded and adulterated devices, but acquitted them of felony charges. Lawyers for both defendants said they felt confident that their clients would eventually be cleared on the misdemeanor counts.

Speaking of Acclarent, the company agreed to pay $18 million to settle allegations that it caused false claims to be submitted to government health programs. The government contended the Acclarent marketed one of its devices for a use that was rejected by the FDA.

The Washington D.C. Department of Health (DOH) released an FAQ sheet that was about as clear as most political speeches. The document is intended to provide guidance regarding a recent change to the D.C. detailer law. Unfortunately, it may have raised as many questions as it answered. The DOH recently made a change establishing that anyone engaged in detailing for less than 30 consecutive days did not have to obtain a license. Confusion seems to center on the Department’s definition of “consecutive.” The FAQ states that the exemption applies to those “individuals, such as speakers at a conference, who come to the District once a year, or other persons that come once a year for a short duration of time of less than 30 consecutive days.”” Makes sense right? But the FAQ also states the exemption is not meant to cover an individual who may come to the District for a few days, more than once during a calendar year. So how many visits to D.C. require registration as a licensed detailer? Stay tuned.

The Centers for Medicare and Medicaid Services (CMS) is conducting a “focus group,” of sorts. The agency is conducting a stakeholder forum on August 2 to solicit feedback on rulemaking and potential improvements to Open Payments. The forum is intended to give stakeholders an additional opportunity to comment on the recent questions posted by CMS about Open Payments in the proposed 2017 Physician Fee Schedule.

Well, that’s a wrap on this politically-charged edition of the Compliance News in Review. We now return you to your regularly scheduled convention coverage.

Stay compliant!

Compliance News in Review, July 14, 2016

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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.

Buy or Build: Is Off-the-Shelf or Custom Online Compliance Training Right for You?

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During a recent compliance conference panel session, a chief compliance officer from a mid-size pharmaceutical company proclaimed, “I only use custom for online training,” and “off-the-shelf just doesn’t meet my content needs.” She went on to explain that with custom-developed training, she could target specific topics and include company-specific policies in a way that she never could with off-the-shelf.

Fair point, but she failed to take into consideration that while custom-developed training can indeed be built to focus on the compliance content she needs to cover, well-built, flexible off-the-shelf training provides a solid foundation of knowledge, which can then be supplemented with targeted, custom micro-learning in the future, as gaps and custom needs demand.

Start with Off-the-Shelf

Small to mid-size pharmaceutical and medical device companies need effective training covering core topics such as off-label promotion, transparency, gifts and meals, and adverse events, but the training resources and budgets available to many compliance departments, which often consist of a staff of one or two, are quite limited. Instructionally sound, industry-focused, off-the-shelf training can easily and quickly provide core compliance training, without draining your limited resources and time.

For obvious reasons, off-the-shelf, even when tailored to include your specific policies and contact information, can be deployed more quickly than a fully custom training course. Review times are shortened and less demanding, and when a need for training on a specific topic (e.g., speaker presentations) is identified, off-the-shelf gives you the flexibility to deploy rapidly while the topic is still top of mind to your learners. Moreover, with quality off-the-shelf training, content is developed by someone with specific knowledge of the industry, and expertise in commercial compliance. Therefore, your time isn’t consumed with being the primary subject matter expert.

A Time and Place for Custom

This is a need for custom online learning in an effective compliance training curriculum – one that addresses all of your organizational risks and truly helps to build a positive compliance culture. The most recent research points to the importance of spacing learning over time and providing review and reinforcement exercises after the initial training is launched to improve retention. As educational psychologist Steven Just, Ed.D., founder and former CEO of the assessment company, Pedagogue, writes, “To learn, you must cognitively act upon the learning materials, and to retain what you have learned, you must actively re-engage with the learning repeatedly over a period of time.” Starting with off-the-shelf, then mixing in smaller, more cost effective, custom mini modules and interactivities (video scenarios, games, assessments) over time and across a well thought out compliance training plan, has been proven to support on-going behavior change – a key objective in the world of commercial compliance.

Summary

While custom online compliance training should certainly play a role in the on-going execution of your compliance training plan, launching a foundation of targeted, off-the-shelf courses to address important topics to a broad audience represents a rational and cost-effective starting point for any life sciences company’s compliance training curriculum.

Don’t forget to “follow” the PharmaCertify™ blog by clicking the blue link on the right so you don’t miss our updates. Coming soon, The Right Stuff: What Compliance Topics to Cover in Your Product Launch Training.

Thanks for reading and stay compliant!

Sean Murphy, Product and Marketing Manager PharmaCertify by NXLevel Solutions

Compliance News in Review – In Case You Missed It, April 2016

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Wow, we’re already a week into May 2016. Time flies when you’re staying compliant. If policy writing, auditing, monitoring, or compliance training development kept you too busy to keep up with all of the April compliance news, not to worry, we have a summary of all the compliance news that was fit to blog throughout the month…with the ICYMI, April 2016 edition of the Compliance News in Review.

A new study suggests drug ads aren’t particularly effective in prompting patients to discuss the advertised drug with their doctor. In fact, only 7% of people were moved to discuss a drug with their physician after seeing a televised ad. While they may not be motivated to speak to their physician, viewers do notice the ads. The survey found that 64% of the respondents said they believed they saw more drug ads over the past year.

Shionogi received a warning letter for omitting risk information on a co-pay coupon for a drug that treats lice. The FDA said the coupon touted the efficacy of the product without stating any of the risks.

The Department of Justice announced a pilot program for companies to self-report violations of the FCPA in exchange for reduced penalties. Under the program, companies that self-report and take steps to remediate identified problems will be eligible for the reduction in penalties.

Pfizer and the DOJ announced the settlement of the case involving Pfizer’s Wyeth unit. The company agreed to pay $784.4 million to resolve charges it had reported false and fraudulent price information to the government.

Ten of Canada’s top drug firms plan to voluntarily disclose aggregate physician and healthcare organization payment data. The movement was started by GSK Canada, and multinational firms like Abbvie, Purdue, BMS, and Lilly soon joined.

CMS held a webinar for Open Payments stakeholders. The agency’s remarks focused on program timelines, in particular, the review and dispute period. A question and answer session for participants was included.

The Massachusetts Medical Society is now requiring its members to disclose financial ties to industry when posting information or reviewing a medical procedure or service on the Internet.

With the review and dispute period for Open Payments in full swing, it is good time to make sure those in customer facing roles are up to date on the requirements of the Sunshine Act, and your company’s procedures for addressing questions from covered recipients. Sunshine Act and Open Payments, from the PharmaCertify Foundations™ curriculum of eLearning modules, provides an overview of data collection and reporting responsibilities, and is easily modified to include your company-specific policy on how to handle questions from covered recipients.

Stay compliant and here’s to a merry month of May!

News and Notes from the 13th Annual Pharmaceutical Compliance Congress

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CBI’s 13th Annual Pharmaceutical Compliance Congress, held last week at the Ritz-Carlton in Washington DC, offered an impressive lineup of industry luminaries and government regulators discussing a wide range of compliance-related topics. While some of the discussions didn’t offer much in the way of groundbreaking information (tone at the top, embed compliance in the businesses, relationships matter, etc.), the concepts presented were critical for any attendees new to their role or the world of life sciences compliance in general.

Embed Compliance into Business Practices

There was the expected emphasis on the concepts of embedding compliance into business practices and gaining buy-in from the C-suite. One panelist even mentioned that when asked to join her current company, she insisted that she be a member of the North American leadership team and therefore have direct access to the business leaders. As another speaker put it, “relationships matter, and you have to speak the language of the businesses in their terms.”

Tie Compliance to Incentives

One compliance officer from a small pharmaceutical company referenced the need to make sure sales incentive is tied to compliance, to make the concepts and policies more meaningful – a concept that was considered revolutionary in the industry just a few years ago. She added that sales management needs to own the compliance metrics in order for there to be lasting and real change. The same global officer touched on the challenges of doing business globally and the need to have tough conversations about spending caps. “You will get pushback,” she stressed, “but don’t compromise. There’s no need to take that kind of risk.”

Transparency: Think Globally, Act Locally

Continuing on the global front, presenters reviewed the merits and details of global transparency codes like EFPIA, while touching on upcoming movements toward laws and guidance. When dealing with global regulations and codes, the potential for confusion reigns. For example, when providing meals to HCPs from various countries, one panelist advised audience members to use the lowest common denominator for the meal limit, BUT, don’t forget to take Loi Bertrand into consideration if an HCP happens to be from France.

In addition, panelists stressed that companies can’t fall into the trap of thinking that because they are familiar with the rules around the Sunshine Act and Open Payments, they can roll right into global reporting. As one speaker from a large pharmaceutical company suggested, you have to look at it differently. “If you approach it like you approach Open Payments, your credibility will be challenged.”

Yates Memo and Individual Culpability

Among the regulators and defense attorneys who spoke during the conference, one common theme was the Yates Memo, and the affect it has (or is some cases, doesn’t have) on how investigations are conducted and cases prosecuted. The Memo, which is named for Department of Justice Deputy Sally Quillian Yates, was released in September of 2015. It generally states that the DOJ will increasingly target individuals in corporate crimes. A number of the regulators stressed that while the Memo is significant in its scope, it will not necessarily change how their offices pursue pharmaceutical and medical device cases. During the U.S. Healthcare Fraud Enforcement Panel, one US Attorney said it “codifies what they have already been doing in her office” and another commented that he asks his prosecutors to always look at individual culpability in each case.

Innovations in Training

As a compliance-focused learning company, we at PharmaCertify™ pay close attention to presentations and commentary with a slant toward training. It’s been a slow process, but based on the information and concepts presented in this and other recent conferences, it’s clear to us that companies are integrating exciting and novel techniques into their curriculums. Innovative compliance departments are adding micro-learning solutions and app-based tools in an effort to raise the level of engagement among their learners, which is music to our ears.

One company representative detailed the planning process and upfront analysis she and her colleagues conduct to ensure that training concepts meet the needs of the business as well as the compliance department. Once those needs are identified, they look for unique ways, including a healthy dose of humor, to make their messages stick. She and her co-presenter reviewed the details of the compliance app recently launched across the company, which uses self-produced video sequences, with compliance department employees as actors, to communicate the concepts. While we agree that technique can help to “humanize” compliance, as we warned in a recent post, you need to be careful that bad acting doesn’t distract from the important messages.

While this year’s Pharmaceutical Compliance Congress featured much of the same themes as recent conferences, the ever-evolving world of life sciences compliance always offers new twists and turns for those tasked with ensuring their individual companies remain in alignment with the latest rules and regulations. These conferences offer attendees the invaluable opportunity to learn best practices, tips, and updates directly from their peers and government regulators from around the world. They shouldn’t be missed.

See you at the next conference!

Compliance News in Review, April 13, 2016

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Industry companies in Canada announce plans to voluntarily disclose payment data. Massachusetts institutes new disclosure requirements, the DOJ offers smaller penalties in exchange for self-reporting, an administrative court in France recommends the provision for allowing DPAs be removed from bribery legislation, and Shionogi receives a warning letter for a co-pay coupon.

April showers bring May flowers, and outside the News in Review offices, we’re already feeling the brunt of that whimsical rhyme. But, the bright colors and fragrant blooms are just around the bend, so we’ll tolerate a bit of turbulent transitional weather for the opportunity to soon enjoy nature’s bountiful beauty. In the meantime, after you dry out the umbrellas and shake off the cold rain, we offer the latest in the compliance news fit to blog, with this edition of the Compliance News in Review.

There’s only Sunshine on the horizon in Canada. Ten of the country’s top drug firms plan to voluntarily disclose aggregate physician and healthcare organization payment data. The movement was started by GSK Canada, and they were joined by other multinational firms including, Abbvie, Purdue, BMS and Lilly. Canada’s industry trade organization praises the initiative. Critics claim the plan will yield no meaningful information, and are pressuring Canadian lawmakers to pass a U.S.-style Sunshine Act.

New disclosure requirements are blooming for physicians in Massachusetts. The state’s Medical Society is now requiring its members to disclose financial ties to industry, including the receipt of free goods or services from companies, when they post information or review a medical procedure or service on the Internet. The requirement comes as a result of growing concern about physicians promoting treatments on social media platforms.

Could a respite from the bribery enforcement storm be on the horizon? The Department of Justice announced a one year pilot program for companies to self-report violations of the FCPA, in exchange for reduced penalties. Under the program, companies that self-report and take steps to remediate identified problems will be eligible for significantly lower fines. The head of the agency’s fraud unit says the program draws a line between companies that self-report and those that cooperate once violations are identified by the DOJ.

There’s a light rain falling on France’s new anti-bribery efforts. The country’s highest administrative court has recommended removal of the provision for Deferred Prosecution Agreements in foreign bribery legislation. The recommendation did not come as a surprise, considering the calls from numerous organizations to remove the provision.

A co-pay coupon brought out the dreary side of the FDA for Shionogi. The company received a warning letter for omitting risk information on a co-pay coupon for a drug approved to treat lice. The FDA says the coupon touted the efficacy of the product without stating any of the risks. The coupon did provide the website addresses where consumers could read the full prescribing information but the letter claims that is not enough to address the full risk information requirement.

The FDA’s position on truthful off-label statements has been the focus of recent headlines. Ensuring that colleagues are trained on the requirements related to promotional statements is critical. According to a study, the FDA cited omission of risk in 60% of the untitled and warning letters that were issued between 2013 and 2015. You can read about our observations on those letters here. Everything from press releases to statements made by hired speakers is subject to FDA oversight, providing training to all who are in a position to make promotional statements is important.

Well, that’s the news for now. We look forward to seeing you, rain or shine, for the next edition of the Compliance News in Review.

The 2016 Pharmaceutical Compliance Congress: a Preview

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On April 26 and 27, compliance professionals and government representatives will gather in Washington, D.C. for the 13th Annual Pharmaceutical Compliance Congress. As usual, the conference offers a cornucopia of sessions and workshops focused on important compliance topics. There is plenty to see and learn, but here are the topics that have piqued our interests:

Day One General Session: FMV Considerations and Emerging Compliance Risk – In this age of transparency, FMV is a hot topic for life science companies and healthcare providers alike. This session, along with the breakout sessions on the same topic, offer a great opportunity to identify emerging risks related to FMV, and learn best practices from industry colleagues.

Day One General Session: EFPIA Initiatives for 2016 and Beyond — Charting the Course for Global Transparency – EFPIA members have completed their first year of data collection to comply with the Disclosure Code. We’re hoping to hear about the early challenges companies are facing and EFPIA’s plans for the future of its transparency initiative.

Day One Track: Product Promotional Compliance – In particular, we are interested in two sessions:

Social Media — New Challenges and Opportunities: While social media presents a unique set of challenges, its affect on life sciences marketing and compliance has to be taken into consideration.

Speaker Programs and Medical Roundtables — Environment and Areas of Risk: In this era of increasing scrutiny, we’re specifically interested in hearing about the emerging risks surrounding roundtables and the strategies for mitigating those risks.

Day One Workshop: Analyze FCPA Updates and Identify Areas of High-Risk to Mitigate Non-Compliance, paired with the Day Two General Session FBI address, International Corruption Squads – the FCPA and Beyond – At the end of 2015, the DOJ announced that it planned to hire 10 additional attorneys for its Fraud Division FCPA Unit. Also, the Serious Fraud Office entered into its first corporate Deferred Prosecution Agreement for violation of the U.K. Bribery Act last year. Enforcement of anti-corruption laws continues to be a priority for the U.S. and governments abroad. Learning about the emerging risk areas, and how various agencies cooperate in enforcement, is key to ensuring that your anti-corruption program is covering all the right bases.

Day Two Track: Fraud, Abuse and Kickback Prevention – The scrutiny of payments to physicians is only going to increase as more entities comb through transparency data. Concern from investigators and enforcement agencies about the potential for kickbacks is growing. The discussion on anti-kickback enforcement trends, and the establishment of compensation limits will be helpful when addressing your organizational kickback risks.

Day Two Discussion Group: Focus on Pricing – Considerations for Compliance as Scrutiny Heats Up – Last year, we saw the largest settlement ($12.4M) under the OIG’s Civil Monetary Penalties Authority. The settlement was over price misreporting, and enforcement in this area isn’t about to let up. This session presents a great opportunity to learn about best practices and the challenges compliance professionals are facing regarding government pricing.

Day Two Track: Compliance Program Structure and Effectiveness – Engage the Organization to Promote Ethics within Compliance

Okay, we may be a bit biased on this one, since Peter Sandford from NXLevel Solutions is one of the presenters, but as your training audience evolves, so should your compliance training. As millennials bring a new sense of energy and expectations to the industry, implementing modern and innovative learning strategies is more important than ever. Peter and his co-presenter, Jim Massey – Vice President, Global Compliance, Enablement & Assurance, AstraZeneca, will share five key principles for integrating creative and engaging compliance training into your organization.

We invite you to stop by the NXLevel booth to see demos of our compliance-focused training solutions and to share your thoughts on the sessions. And while you’re there, don’t forget to enter our drawing to win a Bose® SoundLink® Bluetooth speaker.

Stay compliant and we’ll see you in Washington!