pharmaceutical promotion

The Forgetting Curve and Compliance Training

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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™

Compliance News in Review, January 27, 2017

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The Serious Fraud Office leads the charge on Rolls-Royce’s multi-jurisdictional bribery settlement; the FDA releases new draft guidance; and a new transparency law is on the way in Maine.

While most obscure, strange, and funny “holidays” may be dismissed as whimsy, and fodder for creative water cooler conversations, Chocolate Cake Day is one that we here at the News in Review celebrate with vigor and enthusiasm. From Devil’s Food to Black Forest, we look forward to marking the occasion with more than one variation on theme. In fact, why not just make a weekend of it? Meanwhile, if a day dedicated to the splendors of chocolate cake isn’t sweet enough for you, we offer a delectable morsel of a different type, with this edition of the Compliance News in Review.

Rolls-Royce is getting its just desserts on three continents. The company recently entered into a $800 million multi-jurisdictional settlement with the UK’s Serious Fraud Office (SFO), the Department of Justice (DOJ) in the U.S. and Brazil’s Ministério Público Federal, to resolve charges it paid bribes to foreign officials in Eastern Europe, the Middle East, South America and Asia. In a twist on the usual tale, the SFO, not the DOJ was the agency spearheading the investigation. In addition to the financial penalties paid to each country, Rolls-Royce entered into deferred prosecution agreements with the U.K. and US governments, and a leniency agreement with Brazil.

The FDA is working on a new recipe for sharing healthcare economic information (HCEI). The agency released draft guidance for the sharing of HCEI with payors, formulary committees and similar entities. The guidance includes questions and answers about sharing HCEI related to investigational products with payors. The comment period for the draft guidance began January 17 and will remain open for 90 days.

On the state level, a legislator in Maine read a newspaper report about the increase in promotional spending by companies that manufacture opiods, and decided to introduce a law intended to curtail gifts from the industry to physicians. The language in the bill is based on the Minnesota gift prohibition law

Anticorruption efforts around the world are moving full steam ahead in 2017 and the fact that the SFO is spearheading investigational efforts presents a new twist. We don’t know yet if this is the start of a new trend, but we do know the SFO has the means to investigate and resolve large cases like the one with Rolls-Royce. Since the passage of the UK Bribery Act in 2011, the news around potential investigations has been quiet, but that is clearly changing. Like the U.S. Foreign Corrupt Practices Act, the UK Bribery Act has a wide reach.

Now is the time to review the training components of your anticorruption program to ensure employees, vendors and other third parties are being trained regularly about bribery laws and your company’s policies. Is that training engaging and based on real-world scenarios? Is deployment spaced over time to maximize effectiveness and retention? Have you mixed in smaller, more-focused micro-learning to reinforce topics like “identifying red flags?” Taking proactive steps now will strengthen help reduce risk and strengthen your culture around the globe for years to come.

With that, we put the wraps on this tasty edition of the Compliance News in Review. Until next time, we say, “let them (and us) eat cake!”

Thanks for reading and have a great weekend!

Compliance News in Review, December 12, 2016

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If you’re dancing “The Beagle,” and you can’t break away from all of the movies starring Candace Cameron Bure on the Hallmark Channel, it can only mean one thing; it’s Christmas time! Despite what Staples would have you believe, THIS is the Most Wonderful Time of the Year. Before you fill your heads with dreams of sugarplums, we have a quick yuletide tale to share. Gather round friends to hear the tome; our newsy, Compliance News in Review Christmas poem.

T’was the News before Christmas, and all through the land,

Our readers waited for the first story at hand.

The story was chosen with the utmost of care,

In the hopes of bringing joy and not causing despair.

In Congress a healthcare bill was just passed,

But not without a change that left some hopes dashed.

Despite efforts to exempt, companies will still report

Payments for textbooks, reprints and speaking fees of a sort.

Senators exclaimed the payments we must heed

With the exemption removed, the bill passed with ease.

With the healthcare bill passed and well on its way,

We will move on to news from Californ-i-a.

Away went a bill in the last governing session,

Requiring disclosure of drug pricing information.

Not one to give up, an intrepid senator said,

“I’ll make minor changes. This bill is not dead!”

Change his bill he did, and returned it to the floor.

Companies must report price hikes of 25% or more. (if passed)

Then over at Teva there arose such a clatter!

We wondered out loud what could be the matter?

After one bribery investigation and setting aside cash

A tip came in – to Romania Teva should dash!

Bribes of travel and consulting fees were paid.

Teva is investigating all of these claims.

On the “nice” list of St. Nick we all hope to be,

But this group of execs will be found on “naughty.”

Six from Insys were arrested for inducements

Paid to docs to write scripts for unapproved uses.

The former CEO is one of the six, yes really.

His lawyer exclaimed he would plead “not guilty.”

Others in trouble are from marketing and sales.

Don’t buy the business is the moral of this tale.

With that last story our tale must come to an end.

We’ve enjoyed sharing it with you our dear friends.

So until we return with more news and insights,

Merry Christmas to all, and to all a good night!

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

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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, 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, 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!

Compliance News in Review, March 29, 2016

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New anti-corruption measures are introduced in Australia, the FDA announces a new requirement for opioid labels, PhRMA is sending researchers to Capitol Hill, and Respironics settles False Claims allegations.

Everything’s coming up roses…and daffodils and tulips. Spring fever is here! Of course, with that beauty comes all that not so lovely pollen, but for now at least, we prefer to stay positive. To help pass the time as you wait for old man winter to release his final desperate grip, we offer the Compliance News in Review, blooming with all the recent compliance fit to blog.

Seeds of change have been planted in Australia. Following criticism from the Organisation for Economic Co-operation and Development, the Australian government is taking steps to strengthen anti-corruption measures in the country. Several new anti-corruption measure have been introduced in the last several months by the government. New laws went into effect that clarified that proving intent to influence a foreign official was not necessary to establish a bribery claim, and that strengthened accounting fraud laws. The government also shared a discussion paper regarding the possibility of implementing DPAs in corporate law cases.

The Food and Drug Administration announced it will now require labels on short-acting opioids to include a “black box” warning about the risk of addiction, abuse, overdose, and death associated with use of the products. The warning must include a statement indicating that the chronic use of the drugs by pregnant women may result in a painful withdrawal process for the newborn. The warning applies to over 200 products. The change comes as part of a larger government strategy to combat opioid abuse.

PhRMA is making plans to sprout up on Capitol Hill. The trade association plans to send top scientists and researchers to meet with lawmakers to discuss drug pricing. PhRMA CEO, Steve Ubl, says the organization is going to take a more proactive tact in addressing issues around drug pricing. Mr. Ubl said, “I think it’s fair to say this represents a bit of a pivot for the organization. We’re going to develop a proactive policy agenda, and we’re going to drive it.” In the past, PhRMA has reacted to negativity about extreme drug price increases at companies like Turing and Valeant, by explaining the complexities of drug pricing, or by distancing itself from the companies by pointing out they are not PhRMA member. Moving forward, the organization plans to push for policy that will limit price increases.

The bloom is off the rose at sleep apnea mask manufacturer, Respironics. The company agreed to pay almost $35 million to settle False Claims Act allegations. Respironics was accused of providing kickbacks, in the form of free call center services, to durable medical equipment (DME) suppliers that bought its sleep apnea mask. DME suppliers that did not use the Respironics product had to pay a monthly fee for using the call center. The illegal activity allegedly occurred between April of 2012 and November of 2015.

Well, that’s all the news springing up around here for this edition. Have a great week everyone and may hope spring eternal!

Compliance News in Review, March 8, 2016

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A bill is introduced in the Senate to end DTC advertising, Endo settles with New York over alleged marketing violations, and Olympus settles multiple False Claims Act, Anti0kickback, and FCPA charges.

March has certainly roared in like a lion, but will it go out like a lamb? Or will it go out more like a Blue Devil, a Jayhawk, a Cardinal, or a Wolverine? March Madness is almost here, so rise up bracketologists! Whether you employ a highly-scientific method for filling out your brackets, or you make your picks based on which team colors, it’s time to put pen to paper (or fingers to keyboard) and make you selections official. Before you get completely engrossed in what sixteen seed might have a shot at the huge upset in the first round, let’s take a look at what has dribbled through the newswires lately, as we tip off on this edition of the Compliance News in Review.

Senator Al Franken is the latest to join the “Ban DTC Advertising” team. The Senator has introduced a bill that would end the DTC advertising tax break for drug companies. Franken argues the costs of the ads are increasing the costs of drugs, and they encourage consumers to seek new, expensive medications, over cheaper alternatives. A spokesperson for PhRMA said the legislation “ignores the value of information patients about their health care and treatment options,” and it may have the unintended consequence of a patient not seeking medical attention for chronic conditions that can be managed more cost effectively when treatment begins early.

Endo has resolved a marketing foul with the state of New York. The company reached a settlement with the State over its marketing of an opioid pain medication. According to the state’s Attorney General, Endo claimed its painkiller, Opana ER, was crush resistant and it underplayed the addictive nature of the drug. The AG said the misleading marketing led to increased sales of the drug because it created a “false sense of security.” The company agreed to pay $200,000 and to cease marketing the drug as crush resistant. Additionally, Endo must create a program to keep its sales team from promoting the drug to healthcare providers who may be prescribing it in an abusive manner.

Olympus Corporation of the Americas (OCA), has agreed to pay $646 million to settle criminal and civil charges related to violations of the False Claims Act, the federal Anti-kickback Statue and the FCPA. The endoscope maker was accused of paying kickbacks in the form of consulting payments; free endoscopes; travel; meals; and grants. The company will pay $312 million to settle charges of paying kickbacks and $310 million to resolve the False Claims Act charges. The company’s Latin American subsidiary is accused of making payments to healthcare providers working in government-owned hospitals in Central and South America in order to secure business. The company will pay $22.4 million to resolve charges it violated the FCPA and it has entered into a three year Deferred Prosecution Agreement (DPA) and a Corporate Integrity Agreement (CIA). The DPA requires the establishment of a confidential hotline, improvements to the compliance training and the establishment of a program to recoup executive performance pay for those who participate in misconduct or fail to promote compliance. The CIA requirements include the implementation of a healthcare code of conduct; specific training and education; and requirements around grants and charitable contributions, consulting arrangements, and travel expenses.

The DOJ noted in its press release about the Olympus settlement that “the criminal complaint alleges that the improper payments happened while Olympus lacked training and compliance programs.” A “subpar compliance program,” was also noted by prosecutors in the recent SciClone FCPA case and the Sweett Group UK Bribery Act case. Regular and effective training is a key element of any effective compliance program, and helps reduce the risk of violations. While laws such as the False Claims Act of the FCPA may not change often, training on these laws cannot be conducted in a “one and done” manner. It should be reviewed and refreshed regularly, and highlight real-world examples applicable to the industry to keep it relevant and fresh.

With that, the buzzer has sounded on this edition of the Compliance News in Review. If you have a rooting interest, good luck to your team(s) in the upcoming tournament.

Stay compliant and we’ll see you right back here for the next edition