FDA

Ten Training Takeaways from the 21st Pharmaceutical and Medical Device Ethics and Compliance Congress

PharmaCertify Team , , , , , , , , ,

The Pharmaceutical Compliance Forum (PCF) went to great lengths to replicate the experience of a live conference in this year’s virtual Pharmaceutical and Medical Device Ethics and Compliance Congress. The virtual conference platform featured presentation rooms and realistic exhibit halls that made navigating the user interface simple and logical.

Organizers took advantage of the virtual nature of the conference to maximize the amount of content available through live presentations, along with a plethora of recorded presentations available for viewing any time. In fact, if you attended the conference, the sessions will remain available to you for up to six months – so don’t be shy about logging back in and catching up on what you missed.

I’ve done just that over the last few weeks and in the spirit of the PharmaCertify mission to help you reduce risk and strengthen the compliance culture in your company, here are ten key conference takeaways to help you build a more effective training curriculum.

  1. Meals, meals, meals.
    How to handle meals during the pandemic (in speaker programs and otherwise) continues to be a common refrain during conferences. Speakers from the pharmaceutical and medical device industries touched on the topic, with the conversation mostly focused on the importance of sending meals only to HCPs’ offices and hospitals, and not to their homes. PhRMA’s guidance released earlier this year is a good starting point for updating policies and building new training: https://phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Org/PDF/P-R/PhRMA-Code-Section-2.pdf. Clearly if you have not addressed the way in which meals should be provided in your policies and subsequently in your training, you should.

  2. Remember the changes to the Sunshine Act.
    Speaking of updates, attendees were reminded that the changes to the Sunshine Act go into effect in January. If your core Sunshine Act training hasn’t been updated, you need to make your learners aware of the changes in the list of covered recipients and the nature of payment categories…quickly!

  3. Be aggressive.
    Throughout the conference, government regulators agreed that they tend to view companies that have a robust compliance program more favorably during investigations. Or, as one panelist in the AUSA Roundtable put it, “if you’ve properly dealt with the problem, we’re probably going to go away.” That extends to your compliance curriculum. So not only is a “check the box” approach to training a bad idea in terms of learning, it also isn’t going to impress regulators when they come calling. A modern and effective curriculum needs to be evaluated against your company’s risk, and it needs to be supplemented with regular nuggets of training spread across the learner’s timeline.

  4. Keep the communication flowing.
    An effective curriculum doesn’t end with the deployment of training. The importance of on-going communication during the pandemic was reiterated in multiple sessions throughout the conference. Presenters focused on how the sudden shift in the way business is conducted has forced them to think about how they stay in touch with leadership and the field. The need to think differently has clearly given birth to ideas and best practices that will continue post-pandemic. Whether designating “compliance liaisons” from the businesses to bring ideas and questions back from the field, or rotating people from the businesses through the compliance department, presenters are finding creative methods to ensure compliance stays top of mind for the long term.

  5. Patient support and speaker programs are still in focus.
    Gregory Demske and Mary Riordan reminded attendees that the OIG’s focus is still squarely on patient support programs and speaker programs. And interestingly, Demske encouraged viewers to ask themselves if they really need to go back to in-person speaker programs after the pandemic and warned that the agency is going to continue to look carefully at “payments to prescribers that are under the guise of speaker programs.” Recent CIAs focused on speaker programs and patient support programs are a good starting point as you evaluate your training plan.

  6. Pay attention to social media.
    According to presenters in the social media mini summit, 70-80% of patients get information from online resources. While that’s not a surprising number in our digital age, it’s concerning in light of the dearth of guidance from federal agencies. Presenters emphasized the need to stay abreast of the emerging social media platforms and evaluate training plans in context of the limited social media guidance that is available. And the risks of social media aren’t limited to the pharmaceutical industry. In the Medical Device Roundtable session, one presenter warned that cutting-edge technology often can lead to representatives being overly enthusiastic on social media. It’s a scary, changing world online, and as a compliance professional, you need to be continually addressing it in targeted training.

  7. Customize training for company-specific risk.
    I may be biased, but the discussion about the risk-frequency framework by Dan O’Connor in the State-of-the-Art Compliance Training mini summit is “can’t miss” conference viewing. If you did miss it, let me know, and I will be happy to coordinate a brief review of the concept with Dan. The framework is a great starting point for evaluating the appropriate mix of training based on the riskiness of the activity and the frequency at which that activity occurs. Ours is not a one-style-of-training fits all world and the framework is a good way to look at your curriculum and make adjustments in the tools and techniques to address risk accordingly.

  8. Emphasize a culture of integrity, not just compliance.
    Those of us who have been working in life sciences compliance for a long time know the industry has been touting the need to shift away from a rules-based approach to compliance to one based on values and ethics. That shift is in process and was best summarized by a presenter in the Integrating Ethics and Compliance session when she said she finds the word “compliance” to be limiting and she prefers the word “integrity” to emphasize that how one does something is as important as what someone does. Or, as another presenter in the same session said, “now is the time to create a culture where people are comfortable speaking up.” That’s the language of a values-based approach and it certainly seems like it’s here to stay. Does your training incorporate these themes?

  9. The core rules still apply.
    While COVID-19 has changed the way in which business is conducted and how interactions occur, the core principles of compliance still apply. In fact, as multiple regulators and industry professionals were quick to note, “COVID is not an excuse for non-compliance.” Some of the details may have changed, but speaker programs need to be monitored, speakers need to be trained, reps need to stay on-label, federal regulations still apply,  and state disclosure laws need to be followed.

  10. More risk is okay if you have a strong foundation to manage that risk.
    Many years ago, when I started working in compliance training, I could not have imagined someone being bold enough to publicly say more risk is okay. But there I was in the CCO Fireside Chat, when I heard a presenter confidently say, “striking a balance between the legal environment and business goals is key.” To my surprise, he followed up by saying, “and to help the business be more risk tolerant you need training that is sticky and impactful.” The assessment is an honest and refreshing one, and hearing the word “sticky” used in reference to compliance training brings music to the ears of someone who has been part of a team encouraging the industry to do that for 15 years. The future may be filled with more engaging and dynamic training after all.

    11. Thanks for reading!

    Sean Murphy
    PharmaCertify By NXLevel Solutions

In a Virtual Detailing World, the Rules Regarding Good Product Promotion Still Apply

PharmaCertify Team , , , , , , , , ,

Life sciences detailing has changed, even if only temporarily, but the rules and best practices related to good product promotion have not. As field sales teams acclimate themselves to the reality of meeting with healthcare professionals through virtual means, they need to ensure those rules aren’t lost in the milieu of that change.

For example, no matter the means by which promotional speech is delivered, the FDA defines it as “any affirmative statement about a prescription drug or medical device.” Regardless of format, promotional statements made while meeting with healthcare professionals must always be truthful and accurate.

Representatives must never exaggerate or mislead the healthcare professional regarding the use, safety profile, or any other aspects of the product and any statements made about a product must include the benefits and the risks associated with the use of the product. They must never overstate the effectiveness of the product, make efficacy claims not supported by substantial research or misrepresent clinical study data. Fair balance cannot be ignored just because a rep is not meeting with the healthcare professional in person.

Products may only be promoted for uses approved by the FDA. In fact, if a healthcare professional asks a representative about an unapproved or off-label use, the rep needs to refer the question to the medical affairs department and, even during a virtual visit, a rep must never steer a conversation with the intent of prompting the healthcare professional to ask an off-label question.

Now is not the time to let the emphasis on good and compliant product promotion slip through the cracks. Updated training and microlearning covering topics like promotional speech, the Bad Ad Program, the use of social media, off-label marketing, and the dissemination of reprints and scientific publications is more important than ever to keep field sales teams compliant and effective.

Thanks for reading!

Sean Murphy
PharmaCertify By NXLevel Solutions

Note: the training content shared in this post is from our Good Product Promotion eLearning module, one of the 26 customizable modules available in our Compliance Foundations suite.

 

News and Notes from the 15th Annual Pharmaceutical Compliance Congress

PharmaCertify Team , , , , , , , , , , , , , , , , , ,

CBI’s annual Pharmaceutical Compliance Congress, which took place April 23rd to the 25th in Washington DC, featured industry leaders and government representatives espousing the usual best practices for building and maintaining an effective compliance program, but this year’s agenda offered a few surprises and changes in the regulatory wind. The notes below highlight some of the sessions we found to be particularly interesting and newsworthy.

Day 1

CCO Exchange – Adapting and Evolving Compliance Programs in Support of Innovation

Following the opening remarks and a session covering politics and the pharmaceutical industry, the conference kicked into gear as Maggie Feltz of Purdue Pharma, Jennifer McGee of Otsuka, Jill Fallows Macaluso of Novo Nordisk, and Sujata Dayal of Johnson & Johnson discussed their process for “partnering with business” in the company to maximize the strength of their compliance programs. The panelists stressed the importance of establishing a relationship with business that is built on open dialogue and trust.  Documentation is also key to that relationship and as one panelist pointed out, “the government cares about how you document that you are preventing issues.” It’s important to “shape the way you are perceived in the relationship by using business language,” she emphasized, and to measure your own effectiveness by simply determining whether business is inviting you back to the table. Your compliance program is only effective if you have a seat at that table.

Once the partnership is established, you need to “get the business to think and talk about risk and conduct a benefit-risk analysis,” according to one panelist. Another reminded the audience that Corporate Integrity Agreements (CIAs) hold important clues about topics of focus for the government. This is particularly enlightening considering the recent Aegerion and United Therapeutics CIAs that dealt with third-party patient assistance programs, a topic discussed throughout the conference.

The panelists also covered working with third-party vendors and the need for monitoring and testing of those vendors to ensure they are complying. As one panelist put it, “you need to be sure those companies are applying your standards.”

Stakeholder Spotlight – Strategies for Collaborating with Business Partners to Enhance Compliance Enterprise-Wide   

Gail Cawkwell, Medical Affairs at Intercept Pharmaceuticals, Cecilia Matthews, Human Resources at MedImmune, Gregory Moss, Deputy General Counselor at Kadmon, and Gary Cupit, CEO of PortA Pharmaceuticals provided the business perspective on the compliance/business partnership. The panelists reiterated key points from the CCO session, with one emphasizing the need for the two departments to tackle the issues together as business partners and another seeing compliance not as a goal, but “a base objective that underlies everything.”

One panelist emphasized the need to be aggressive in the approach, pointing out that she is the person “bothering the compliance department, digging into SOPs, asking why they do things that way, and asking how each policy helps the company.”  She prides herself on partnering with compliance to “find a better way to do it.”

Highly-Acclaimed U.S. Healthcare Fraud and Enforcement Panel – Past and Present Prosecutor Parley

A large group of current and past government enforcement representatives covered the current compliance risks facing the life sciences industry. The session started with a discussion about the nation’s opioid crisis and how each office is addressing the epidemic. One current assistant U.S. attorney summarized the threat to the industry succinctly, “If your company is involved in opioids at all, you are under intense scrutiny.”

In one of the more interesting moments of the conference, the panelists pointed out that the focus on off-label enforcement has shifted away from large pharmaceutical companies to smaller ones. According to one speaker, small companies and startups are under greater pressure to sell and to save money, especially if they are funded by venture capital companies. That leads to a higher risk of off-label promotion.

Continuing a theme, prescription assistance programs and patient charities were addressed in relation to kickback risk. As stated, “any coordination between the charity and the company that shows the company is just trying to pay for its product being prescribed is a concern.” At least two current regulators supported the idea of self-disclosure and being honest about potential violations. “Being candid about where the compliance program has fallen short and the steps the company is going to take to correct the problem is important,” one of them said.

The group of former regulators, who mostly now serve as industry counsel, touched on exclusion as a risk. While it may be considered a rarely-sought tool, prosecutors have the threat of exclusion available to them as leverage. They also delved into the importance of data and reminded the audience that prosecutors are indeed scouring Sunshine Act data.

Patient Assistance Programs and Reimbursement Hub Services Compliance – A New Wave of Enforcement Actions

Attendees were provided five options for the first breakout sessions. The PAP and Hub Services panel was moderated by Jane Yoon of Paul Hastings LLP, and featured Peter Agnoletto of Sanofi, Sarah Whipple of Akebia Therapeutics, and Evan Bartell of KPMG LLP.

The discussion began with a polling question asking attendees where the management of donations sits in their organization. Corporate Social Responsibility and the Grants Committee were the top answers. The question led to a discussion over best practices, with one speaker warning, “you at least need to take commercial out of any involvement with donations.” Another admitted that not having a say in how the money is spent is hard concept for the business to grasp but the separation is important.

In the next polling question, attendees were asked if they monitor relationships and interactions with the foundations. 57% replied yes, and 28% said no. The panel reminded the audience that recent CIAs included the stipulation that those relationships are monitored.

Another question was focused on sales representatives and their involvement with donations. 48% of the audience said their reps are provided with talking points. Panelists suggested that if the sales reps are involved, compliance needs to understand how the information is being used. Clear guidelines need to be established and the reps need to be trained on those guidelines.

Off-label Communications – Deep Dive into the New Regulatory Updates and Actions

Angela Rodin of KPMG LLP and Laura Terrell of DLA Piper LLP presented the update on the status of off-label promotion trends and enforcement in the industry. Starting in 2012, enforcement shifted, as companies argued that off-label marketing is protected under the First Amendment and therefore cannot be prosecuted under misbranding provisions of the Food, Drug, and Cosmetic Act (FDCA). One presenter pointed out that while the government is no long pursuing off-label promotion as a stand-alone FDCA case, it continues to enforce False Claims Act (FCA) and Anti-Kickback Statute (AKS) cases related to off-label promotion.

The bottom line is that even with strong support of free speech as a defense of off-label promotion, life sciences companies still need to be cautious. Clear and effective training is still needed.

Social Media – New Challenges and Updates

Elizabeth Kim of Loeb & Loeb LLP began the social media presentation with the underlying premise that while the digital landscape has changed dramatically over recent years, the legal landscape remains the same. Even on social media, promotional statements cannot be false or misleading and communications must be consistent with labeling and fair-balanced.

Social media is challenging, the presenter stressed, because it promotes a dialogue, which means the company has a lack of control over the conversation. But there are some steps companies can take that at least help with the control. The ability for readers to comment on posts can be turned off on Facebook. No such control exists with Twitter. In addition, key words can be flagged on Facebook to help monitor comments. Unfortunately, as the presenter noted, most companies lack the resources and personnel to properly monitor social media outlets.

She also mentioned that while companies have no obligation to correct third-party, independent comments, public, unsolicited requests for off-label information must be met with a limited response to contact Medical Affairs only. “If you do reply,” she said, “responses should be narrowly tailored. Watch out for getting into arguments.”

The FDA’s Office of Prescription Drug Promotion (OPDP) has issued 233 warning letters over the last ten years for omitting information, minimizing risk information, and overstating efficacy claims on social media. As existing platforms evolve, and new ones appear, the need for updated training to ensure your field-based employees are abiding by laws like the FCA and FDCA, as well as OIG guidance and the PhRMA Code, is critical.

Medical Affairs and MSL Oversight

The Medical Affairs panel included Tina Beamon, Alicia Temoche, and Stephanie Macholtz from Alexion Pharmaceuticals, and Christine O’Connor-Fiore from Boehringer Ingelheim. The session began with the panelists establishing the general rules for how Medical Affairs may interact with healthcare professionals. Attendees were reminded that Medical Affairs can “do things R&D and Commercial cannot do” and “they are not limited to the label.” MSLs provide training to consultants for speaker programs but in the words of one panelist, “they are not Commercial and their integrity must be protected.”

The panelists admitted that the model for Medical Affairs and Commercial interactions has changed in reaction to marketplace changes. Medical Affairs should share insights as long as those insights are not off-label. “The walls between Commercial and Medical Affairs are coming down,” she said, “and a framework needs to be in place to protect the integrity of the MSL.”

Behavioral Compliance – Using Psychology to Make Programs More Effective

In one of the more unique sessions I’ve witnessed in years of attending compliance congresses, this session focused on behavioral compliance as a tool for generating more compliant outcomes. Yogesh Bahl, of AlixPartners, Kevin Ryan of Novo Nordisk, and Charlene Davis of Sun Pharmaceuticals provided conceptual concepts around the philosophy and practical application of behavioral compliance, using ideas known as “ethical nudges.”

The session began with the audience being asked to provide feedback on which of two compliance posters they thought were more effective. Essentially, one reflected a “rules-based” approach, and the other a “values-based” one. The values-based poster was the more popular choice and the content of the session supported that approach. The underlying premise behind the ethical nudges is that “people become ethical by doing ethical things.” Ethical nudges were essentially defined as “interactions based on the understanding of internal decision-making to promote desirable choices.” They included “read and affirm” documents presented right before a critical HCP interaction, visual cues like signage and posters, and micro-training launched strategically in conjunction with the need for ethical decision making.

Critical CIA and Enforcement Learnings – Zero-In on Emerging Trends to Elevate Compliance Safeguards      

The key points of this session were no surprise considering the oft-repeated focus of recent CIAs. BJ D’Avella of Deloitte and Touche LLP and Seth Lundy of King & Spalding LLP reminded attendees that “the focus of CIAs had shifted to interactions with patients, and more than ever, companies need to have a Risk Assessment and Mitigation Plan (RAMP) in place.” That RAMP needs to include activity-based risks in addition to the usual product-based risks.

One of the presenters pointed out that the OIG is focusing on a “smaller number of CIAs that send messages to the industry.” He reminded the audience that CIAs are not laws, but they are a strong indicator of where to focus risk mitigation efforts.

Day 2

CCO Scenario Symposium – What Would You Do?

After a review of the sessions and events of Day 1 by Michael Shaw of GlaxoSmithKline, Day 2 began with this session, during which panelists were asked to participate in a mock case study of “Bad Pharma Co” and expand on lessons learned from this fictional company. Beth Levine of Regeneron Pharmaceuticals, Ashley Watson of Merck, Jerald Korn of Tesaro, and Keith McGahan of Spectrum Pharmaceuticals were asked to discuss the optimal organizational structure companies like the mock one presented in the case study. One presenter felt that having compliance as part of the legal department was a benefit because it gave her greater access to the CEO and others in the board of directors. Others felt that if compliance has that type of access, “it doesn’t matter where they sit.”

Other scenarios brought up in the case study led presenters to offer tips on dealing with compliance situations and those who raise the concerns. For example, one speaker emphasized that “no matter the source, the company’s obligation is to search for the facts of the case.” Speculation about the whistleblower and his or her credibility should not come into play. Also, “if someone sends information about a violation anonymously, it needs to be kept that way.”

Meeting of the Enforcement Minds

Heather Johnson from the Federal Trade Commission, Sally Molloy from the Department of Justice, and Eric Rubenstein from the OIG presented their suggestions for companies to keep their compliance programs attuned to current regulatory challenges. On the topic of bribery for example, one presenter suggested that “internal controls need to be robust and designed so that they are not siloed. It’s all bribery.” Another emphasized that recent trends point to Medicare and Medicaid fraud as a primary source for qui tam cases.

Beyond the Seven Elements of and Effective Compliance Program – What Else Are You Doing?

As a compliance training company, this session, featuring Jerald Korn of Tesaro, Chad Morin of bluebird bio, and Gregory Moss of Kadmon Holdings, held particularly interest for us. As one presenter stated, “creating a brand for the compliance department is a fun way to convey important information.” That holds true for the training as well, and we work with companies to create a continuous, engaging, and “fun” curriculum.

Another speaker noted the importance of being creative in the policies to help ensure compliant behavior, as well as the need to establish a collaborative culture. As stated, “you’re not trying to check the boxes on all seven elements, you’re trying to build a robust program that is effective.”

Existing and Emerging State Laws Governing Transparency Reporting

The state laws presentation, with Maggie Feltz and Michael Grandison of Purdue Pharma, and Brian Bohnenkamp of King & Spalding, LLP, began with tips for managing aggregate spend:

  • Train company-wide, not just the sales force
  • Train, retrain, then train some more
  • Monitor throughout the year

The panel pointed out that state laws fall into three categories; drug pricing transparency, aggregate spend laws, and sales representative licensing and reporting laws. The landscape across all three changes quickly and they expect 2018 to be as busy as 2017.

In recent state-related news, Maryland’s law was found to be unconstitutional and according to one panelist, that “has quieted some of what other states have been considering.” Oregon was brought up as the most challenging law since it “requires documentation to support your documents.” In New Jersey, where the law was passed on the last day of the outgoing administration, one speaker mentioned that Governor Murphy’s team is considering major changes. On the drug pricing front, the panel expects two or three more laws to be implemented.

Obviously, the state law landscape is confusing and changes are happening at a dizzying rate. As one speaker emphasized, diligence, and continuous training is necessary to “ensure every decision-maker is aware of new requirements.”

Maximization of Compliance Resources

I close with what may have been the best session of the entire conference! (okay, I may be a bit biased since this panel included my colleague, and head of PharmaCertify, Dan O’Connor.) Dan was joined by Chad Morin of bluebird bio and Laurie Kathleen Durousseau of Rigel Pharmaceuticals. The session focused on how compliance professionals can best focus their time and energy toward those activities that are most critical during the various growth stages of a life science company from pre-clinical to established.

Starting with a quick poll of the audience, the panel first determined the average size and stage of companies represented. Most of the audience members were an “n of 1” compliance department in a company with 200 or fewer employees that is in the “Clinical” or “First Product” stage. The panel then shared their suggestions for which compliance-related activities to prioritize during each growth stage. In the “first product” stage for example, aggregate spend transparency reporting; government price reporting; specialized training by function; and patient support program design were discussed, among other topics.

The panelists also covered the need for small departments to partner with the business, as well as other departments, to spread the resource load and accomplish the objectives of each stage. For any compliance department challenged with limited resources and personnel, it was a worthwhile thirty minutes of learning. If you missed the conference, Dan would be happy to provide his perspective on the topic. Feel free to contact him at doconnor@nxlevelsolutions.com.

Summary

The world of life sciences compliance is changing, and so is CBI’s Pharmaceutical Compliance Congress. This year’s conference presented a compelling balance of traditional content that newcomers to the field should find valuable as a base of knowledge, with enough updates on key areas of regulatory focus (off-label, patient assistance programs, state laws, etc.) to keep the seasoned compliance professionals in the audience satisfied with agenda. It also offers industry professionals a rare opportunity to meet face-to-face with their peers and hear best practices for strengthening their compliance cultures and reducing risk. I highly recommend the conference next year for chief compliance officers, specialists, managers, and anyone working in the life sciences compliance training industry. Kudos to CBI and all the presenters!

Thanks for reading.

Sean Murphy
Editor, PharmaCertify Compliance Training Insights Blog

The 2017 Compliance Year in Review!

PharmaCertify Team , , , , , , , , , , , , , , , , , , , , , , , , , , ,

As the year winds to a close, we take a break from the hustle and bustle of holiday preparations to reflect on the 2017 trends, topics, and focal points from the world of life sciences compliance. It’s been a busy year, with some expected updates, along with a few surprises, filling our News in Review missives from month to month. So, grab a cup of egg nog, fire up the Yule Log on YouTube, and enjoy this “year in review” edition of the Compliance News in Review.

Drug pricing transparency was a hot topic at the end of 2016, and the trend carried through 2017. The rules for Chicago’s new sales representative licensure law, which is intended to help combat opioid addiction, went into effect. The law requires representatives to obtain a license to sell products in the city and to document their interactions with healthcare professionals. In California, drug manufacturers must now notify the State and other payers in advance when they intend to raise the wholesale acquisition cost of a drug over a certain percentage, and when new drugs are expected to have a wholesale acquisition cost that exceeds the Medicare Part D specialty drug threshold. Nevada passed similar legislation, but its law focuses on diabetes drugs. Nevada also requires sales representatives to be licensed and provide reports of their interactions with HCPs. Finally, Louisiana also jumped on the pricing transparency train.

In an effort to combat the opioid crisis,  Governor Christie in New Jersey issued rules that cap payments made to healthcare professionals by pharmaceutical companies.  Maine passed a gift ban law similar to the existing Minnesota law and, not surprisingly, we heard from Vermont in 2017. The attorney general there is reportedly investigating whether drug and device companies are adhering to the state’s HCP gift ban law.

Not all state-level action was successful. Missouri’s proposed price transparency law did not pass during the past legislative session, and a bill in California to restrict gifts and payments to HCPs passed the state Senate, but was rejected in the Assembly.

Pharmaceutical support for patient assistance charities was another 2016 hot topic that continued through 2017.  An IRS investigation into one of the charities focused on whether it provided an improper benefit to pharmaceutical donors by using the donations to purchase the drugs manufactured by those same companies. Support of patient assistance charities also figured into one company’s healthcare fraud criminal and civil settlement with the government.

2017 was a quiet year for the Office of Prescription Drug Promotion (OPDP). During December of 2016, the agency dropped a flurry of letters, but 2017 will likely see record low in activity with only three letters being issued so far for the entire year.

This was an interesting year in bribery and corruption enforcement. It began with a bang in January as the Serious Fraud Office entered into its first major Deferred Prosecution Agreement. With a changing of the guard in the U.S., FCPA actions were more subdued, but the diagnostic test company, Alere, settled with the Securities and Exchange Commission over improper payments to foreign officials allegedly made by its Colombian and Indian subsidiaries.

The Department of Justice (DOJ) published its Compliance Program Evaluation Guidance in 2017. The document offers details on what the agency considers to be an effective compliance program. Perhaps most notably, the DOJ made its Foreign Corrupt Practices Act Pilot Program permanent. The pilot program ended in early 2017, but it was effectively made permanent with the announcement of a new FCPA Enforcement Policy. Like the pilot program, the new policy encourages companies to self-report possible FCPA violations and rewards companies for their  cooperation during investigations.

With that, we close out another issue of the Compliance News in Review, and another year in the wonderful world of life sciences compliance. We look forward to keeping you up-to-date on all compliance news fit to blog in 2017 and continuing to provide you with an ever-expanding suite of PharmaCertify compliance training products and services.

Thank you for reading. Have a warm and wonderful holiday season and a happy New Year!

Open Payments Funding and Another Kickback Case in the News

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

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

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

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

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

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

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

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

Have a fun and festive Thanksgiving holiday!

Life Sciences Compliance Congress West: A Preview

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CBI’s 8th Annual Life Sciences Compliance Congress West kicks off in San Francisco in two short weeks. During the packed two-day conference, an esteemed lineup of industry professionals and government regulators will address the emerging risks facing life sciences companies. It’s a great opportunity to share notes and best practices with your peers and industry leaders. If you’re considering attending, we can help with a discount on the registration fee.

In the meantime, we’ve perused the agenda to note the sessions that hold the most interest:

Day 1

Session: Industry’s Guide to GDPR

The General Data Protection Regulation of the European Union, or GDPR, applies to companies that control or process the personal data of EU citizens, regardless of geographic location. That’s a wide reach, and your employees need to understand how their role helps ensure compliance with this new and potentially confusing regulation.

Session: Navigate the Complexities of Patient Assistant Programs (PAPs), Reimbursement Support and Patient Services Compliance in an Era of Ambiguity

Industry assistance for patients is an emerging enforcement area in the U.S. and abroad. Several U.S. companies have received subpoenas from the DOJ centered on their relationship with patients assistance organizations. This session covers the compliance issues related to patient support and the strategies for reducing risk.

Session: Small to Mid-Sized Boot Camp

We may be a little biased on this one, since our own Dan O’Connor, Senior Vice President of PharmaCertify, will join Jim Schneider of Seattle Genetics and Jane Wright-Mitchell of AcelRx to cover compliance governance considerations and key elements of compliance program development. It’s a must-attend for anyone building out a curriculum for an emerging company.

Day 2

Keynote Session: A Journey to the Dark Side of International Business and Steps to Protect Your Organization

Presented by a former FCPA Violator turned FBI/UK Cooperator, the session covers a range of international business practices and pitfalls. We expect topics to include privacy; patient interactions; bribery; and compliance risks when conducting business internationally, all critical information whether you’re updating an existing compliance training curriculum, or building one from scratch.

Session: Operations Management — Align Compliance Strategy with Emerging Risks on the Horizon for 2018

As new life sciences compliance risks emerge, training content, and the methods by which those risks are addressed, need to evolve. This session may offer tips for identifying curriculum gaps as well as the overall program adjustments needed to strengthen your curriculum and reduce risk.

Summary

We’re looking forward to catching up with our friends and clients at the 8th Annual Life Sciences Compliance Congress West. If you’re attending, don’t forget to stop by our booth to say hi and see demos of our newest Compliance Foundations™ eLearning modules, QuickTakes™ reinforcement tools, and compliance workshops. While there, don’t forget to enter our drawing to win a JBL Flip 4 Waterproof Portable Bluetooth Speaker.

See you in San Francisco!

Compliance News in Review: the 2016 Year-End Summary

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Here we are again. Another 584 million-mile (940 million km for our metric friends) trip around the sun is nearly complete. It seems like just yesterday we were celebrating the beginning of 2016 and now we’re picking out our favorite brand of champagne to celebrate its end. Before we break out the noisemakers and party favors, let’s take one last nostalgic look back at some of the life sciences compliance-related developments of 2016.

A new milestone was reached regarding HCP spend disclosure. The first disclosure reports under the EFPIA Disclosure Code were released in 2016. Gaining disclosure authorization from individual HCPs proved to be a challenge for the industry and the numbers of doctors who granted authorization ranged widely between countries. According to Britain’s pharmaceutical trade association, ABPI, 70% of their HCPs granted authorization and in Ireland, just over half of HCPs did so. In other transparency developments, ten of Canada’s top drug firms announced plans to voluntarily disclose aggregate physician and healthcare organization payment data. The movement was started by GSK Canada, and other multinational firms including Abbvie, Purdue, BMS, and Lilly followed.

Drug pricing was a big story in 2016. Former CEOs from Turing and Valeant were called to testify before Congress about drug price hikes, and Mylan’s CEO was called to testify over dramatic increases in the cost of an EpiPen. Laws that would require drug companies to disclose information about their pricing decisions were proposed in several states, and a bill was introduced at the federal level with similar requirements. Even with those high profile stories making headlines, only one pricing disclosure law successfully passed this year – Vermont. That law requires a select group of manufacturers to provide information about the factors related to price increases.

A handful of former Insys employees had an eventful year. A former sales representative entered a guilty plea to charges of fraud, and a district sales manager and a several of top executives were all arrested on charges they paid kickbacks to doctors. The drug at the center of the charges is the opioid painkiller, fentanyl. Prosecutors and enforcement agencies claim the individuals offered a variety of kickbacks to doctors to increase prescriptions and encouraged them to prescribe it for unapproved uses.

2016 was an active year for settlements related to bribery cases. GSK, AstraZeneca, SciClone, and Novartis all entered into settlements with the SEC over activities conducted by subsidiaries in China. Orthofix and Teva both set aside cash in anticipation of resolving the FCPA-related charges. Olympus entered into a $22.8 million settlement with the DOJ to resolve charges that a subsidiary covering Latin America paid bribes to healthcare professionals working in government facilities in order to increase sales of product.

We saw a couple of legal “victories” for the industry in the debate over sharing truthful off-label information. In the Amarin case, the FDA decided not to appeal a judge’s decision that allowed the company to share truthful off-label information about its fish oil product. In addition, in proposed jury instructions for a medical device case, the DOJ indicated that it is “not a crime for a device company or its representatives to give doctors wholly truthful and non-misleading information about the unapproved use of a device.”

With a string of legal decisions favoring the industry, the FDA held a public forum in November concerning the ability of drug and device makers to share off-label information. The primary topic was whether the agency needs to revise its regulations considering recent legal decisions and the forum was attended by various stakeholders representing both sides of the argument.

With that, we complete our look back at 2016 and the stories that made headlines in the world of life science compliance. It was an eventful year, and everyone at the Compliance News in Review is excited to see what the new year holds. Thanks for joining us throughout the year and best wishes for a happy, healthy, and compliant 2017!

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.

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!

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!