News and Notes from the 15th Annual Pharmaceutical Compliance Congress

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

Compliance News in Review, January 27, 2017

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 – In Case You Missed It, April 2016

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

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

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

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

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

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

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

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

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

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

News and Notes from the 13th Annual Pharmaceutical Compliance Congress

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

Embed Compliance into Business Practices

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

Tie Compliance to Incentives

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

Transparency: Think Globally, Act Locally

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

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

Yates Memo and Individual Culpability

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

Innovations in Training

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

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

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

See you at the next conference!

The 2015 Pharmaceutical Compliance Congress: A Review

The Sixteenth Annual Pharmaceutical Regulatory and Compliance Congress, in Washington DC, featured legislators and industry leaders discussing hot topics and best practices to a diverse and rapt audience of compliance professionals.

Annual OIG Update from Mary Riordan

The opening plenary session kicked off with the annual OIG Update, from Mary Riordan, Senior Counsel, Office of Counsel to the Inspector General. In addition to her usual review of recent settlements actions (False Claims and otherwise), and the OIG’s Fiscal Year 2015 Work Plan, Riordan focused on the responsibilities of boards of directors in company compliance functions, and urged the audience to use the OIG’s April 2015 Practical Guidance for Healthcare Governing Boards on Compliance Oversight as a starting point for those expectations. Staying on the topic of board responsibility, she pointed out that prior to her appearance at the conference, Millennium Health LLC had entered into a Corporate Integrity Agreement that requires the company to maintain a majority of independent (non-executive and non-family) directors as part of the settlement.

When stressing that kickback concerns continue in the industry and for her agency, Riordan suggested that attendees “think about the kickback risks associated with financial relationships and strive to identify the relationships that would implicate risks.” What controls are in place? Are those controls meaningful and effective? She emphasized that the OIG was there to help and their goal is “not to collect penalties, rather, it is to encourage companies to comply.”

She also focused on individual accountability and reminded the audience that “individual accountability at all levels of organizations is under fresh scrutiny as the OIG tries to identify individuals responsible for misconduct.”

AUSA Panel

The Assistant US Attorney’s (AUSA) Panel followed with Charlene Keller Fullmer from the US Attorney’s Office in Philadelphia, Jeffrey Steger from the Civil Division of the DOJ, and Kristen Williams from the US Attorney’s Office in Los Angeles, presenting their views on the direction of compliance enforcement. Keller Fullmer said her office continues to see off-label cases focused on kickbacks, particularly with small companies and medical device companies. She pointed out that with smaller companies, pinpointing a paper trail is an easier and less cumbersome process than it is with the larger companies. Following up on Mary Riordan’s comments, she also suggested a review of recent CIAs, and their emphasis on individual accountability.

Williams recited her office’s mantra of “come in, come early, and come often” when discussing how companies should react to an investigation. Demonstrating a robust approach to compliance is critical when she evaluates a compliance program. She recommends a proactive approach, one in which a company responds to issues, before those issues even arise in that company.

For Steger, the key to a successful compliance program is one that involves more than just compliance personnel (a theme throughout the conference). Is compliance part of the company’s culture? Has the company taken proactive steps to initiate and invite feedback, e.g., an 800 number compliance tip line?

FBI’s New Focus on FCPA Investigations

The next plenary presentation was a bit of a twist on the usual agenda, as Jeffrey S. Sallet, National Chief of Public Corruption and Civil Rights for the Federal Bureau of Investigation, offered the update on the Foreign Corrupt Practices Act (FCPA) from the Bureau’s perspective. The focus was on a “five pillars” approach to successful enforcement and according to Agent Sallet, only through a partnership with the public, industry, and other governmental agencies like the SEC, DOJ, and IRS, can the FBI be successful in its goals to encourage a global culture of compliance.

Agent Sallet’s enthusiasm and energy was a tough act to follow and after a break, Thomas Abrams, Director, Division of Drug Marketing, Advertising and Communications, Food and Drug Administration followed up with his annual FDA-Office of Prescription Drug Promotion (OPDP) update. As per usual, Abrams presented a plethora of notes and comments describing the FDA’s efforts over the last year, a high-level review of the document and advertisement submission process and summaries of guidance released and/or updated by his office. These include the 2014 guidance documents on the use of social media.

Abrams closed with a great example of a sales aid that spurred a warning letter from his office. The product being promoted was contraindicated for children under 6 year of age, but the aid included an image of a very young child in its montage of images, and it included no risk information. Seeing such a clear violation provided a concrete and powerful case for why companies need to take the OPDP’s guidance seriously, and regularly test the process for submitting samples through the agency’s email dedicated to that process – ESUB@fda.hhs.gov.

Chief Compliance Officer Roundtable

Following the FDA presentation, a Chief Compliance Officer Roundtable focused on the evolution of compliance programs following the expiration of Corporate Integrity Agreements. CCOs from an array of pharmaceutical companies agreed that while the end of the CIA did not cause drastic changes in their programs, it afforded them the opportunity to expand how they approached topics like training.

One panelist began by stating that on Day 1 following the expiration, there were no public displays and no celebrations, saying “it was business as usual.”

Another panelist recalled that her department was relieved that they could now think beyond four hours of online training and include “short spurts of training throughout the year.” When asked about tracking that training, the panelist admitted that doing so was sometimes a challenge, but the organization was able to “focus on getting back to their true purpose, educating the learners.”

A third panelist brought up the topic of policies and how the shift to a post-CIA environment gave them an opportunity to survey the full staff for thoughts on what works best in compliance polies and subsequently revamp those policies based on that feedback. The company even hired a creative agency to help them create documents that presented policy content in a more graphical and engaging fashion.

The fourth panelist emphasized the importance of developing a risk assessment model and addressing risk-based needs accordingly. Others agreed, emphasizing that they are now using data analytics gathered during the CIA to address those risks.

FCPA Anticorruption Panel

Day 1 closed with a unique twist on the standard presentations, as a panel of in-house and outside attorneys discussed the FCPA through the lens of a hypothetical case. The structure offered a relief from the standard didactic approach to the content, with moderator, Gary Giampetruzzi, Partner at Paul Hastings, guiding panelists through the scenario.

The scenario was structured and branched in a manner that allowed for gray areas and debate as to the best resolution for each question. As an example, when discussing whether post CIA, the Compliance department should be moved back into the Legal department, one panelist avoided what may have seemed the obvious answer of “no,” and stressed that combining the two would be okay if Compliance still had independence despite the structure. An attorney on the panel agreed, especially in terms of the Foreign Corrupt Practices Act, having that independent voice is the key.

US DOJ Civil Section Update

Day 2 started early, with an 8:15 AM update on the DOJ Civil Section from Benjamin Mizer, head of the agency’s civil division. Mizer discussed the growth in qui tam civil cases (FY 2014 saw 469 healthcare-related cases) and presented compelling statistics on the cases involving rewards to relators. In a comment that was prevalent throughout the conference, he reminded the audience of the government’s use of data to expedite investigations and make a decision as to whether or not to proceed.

Update from CMS on Open Payments

The highly-anticipated presentation from Douglas Brown of CMS didn’t disappoint attendees interested in learning details around the data collected and the updates/improvements to the Open Payments system. Brown pointed out that covered recipients with higher counts of payments records were more likely to review and dispute transfers of value, and there were just over 30,000 disputes, equally divided across teaching hospitals, physicians and principal investigators.

On the enhancements front, the agency is focusing on eliminating the character limitations in the system, so email addresses won’t be blocked. The ability to download reported records will also be enhanced to include dispute information and recipients will have the ability to exchange contact information with the reporting entity to further facilitate the review and dispute process.

After providing the audience with a number of reminders, (e.g., device names are now required on submissions, and TOVs to physician-owned distributors are considered indirect payments and must be reported), Brown informed the attendees that the next Open Payments Open Session Webinar is scheduled for Thursday, October 29th.

Qui Tam Panel

The Qui Tam Panel started with Jillian Estes of James Hoyer Newcomer & Smiljanich, PA, reviewing her recent representation of a relator who worked undercover seven years in a pharmaceutical company investigation. Estes used the case to describe who she considered the ideal relator – a principle driven person with a fearless mindset, who is willing to suffer the consequences of a whistle blower. The individual needs to be realistic in expectation and understand that the process is a long one, usually 3-5 years.

Joseph Trautwein, of Joseph Trautwein & Associates LLC, made it clear that the reason potential relators come to him is because they went to their employers first and the situation was not corrected. The panel listed the characteristics of a good whistleblower case:

  • A lie took place
  • A party benefits form the lie
  • The scheme can be easily explained to the government
  • There is enough evidence of misconduct that the complaint will survive a motion to dismiss
  • There is proof of damages
  • It’s a “good story”

Off-Label Communications and the First Amendment

In the final plenary session of the morning, Paul Kalb of Sidley Austin LLP, delved into the Amarin and Pacira lawsuits, whereby the companies presented the argument that criminalizing off-label promotion when it is used to communicate truthful information is unconstitutional. Kalb reviewed the potential ramifications of those cases and closed with the reminder the proverbial jury is still out on how on-going cases will be settled. Based on recent rulings though, we are fast approaching a fork in the road in this core and critical compliance issue.

Mini-Summit: Evaluating Compliance Program Effectiveness

Among the first series of “Mini Summit” breakout sessions, I chose to attend the Evaluating Compliance Program Effectiveness – Board Responsibilities, Board Advisors, and Compliance Experts panel discussion and Q&A.

The first panelist indicated that a good starting point for evaluation of the program is how the company manages high-risk third parties. Are there strong and effective controls in place for third-parties doing business on behalf of the company? Another stressed the need to have outside counsel involved in the program to provide an outsider’s view on the process and the program. A third panelist felt strongly that having people with different backgrounds on the compliance team is important. He also suggested that attendees look at the OIG’s recent guidance for board oversight of the program. “The board needs to demand frequent dialogue,” he said. Another felt that board members have a responsibility to ask questions, review the data, and speak up.

When evaluating training, one panelist emphasized the power of employee surveys to assess whether all participants understood the content of the training. When an audience member asked whether those surveys should be broad or targeted, that panelist said it depends on how each company operates and another added that at his company, they survey the entire employee population.

One panelist also warned the audience about the risk of getting too comfortable in their policies and procedures. New people coming into the company may be coming from a different industry, and may not have had orientation to a compliance program. “Be ahead of the curve,” he said, “when decisions like Amarin come down, you need to be having a conversation.” A fellow speaker followed with the need for an interaction between compliance and the businesses. “It’s important to vet your compliance procedures with the business owners,” he said.

Mini-Summit: Managing Multi-national HCP Meetings

In the Managing Multi-national HCP Meetings: Complying with the Codes and Transparency Requirements session, a panel from around the world discussing the codes and laws relevant to their particular regions.

One industry executive discussed the challenge of holding meetings with physicians from around the world, who each bring their own set of rules from his or her home country. For example, when holding an advisory board with multinational participants, how should meal limits be addressed when those limits vary? The company establishes ground rules but allows common sense to prevail – for example if a limit is slightly above the physician’s home limit, allowing the meals may be a more realistic approach. The executive added that it’s important to create a list of approved meeting places in each country and to train travel agencies on that list.

Hwa-Soo Chung of the Kim & Chang Law Firm in Seoul, South Korea, reviewed the rules in her country, where practices are driven by industry codes with strict limits on speaker meetings no matter where the meeting is held. That severely restricts how much companies around the world can invite Korean doctors to their meetings.

According to Yuet Ming Tham, of Sidley Austin and former Asia-Pacific Compliance Director for Pfizer, “the biggest risks are Korea and China.” The companies she works with will go for lowest meal limit among the group of physicians. In terms of content, companies should always follow the rules of where the meeting is taking place.

Summary

The Sixteenth Annual Pharmaceutical Regulatory and Compliance Congress managed to deliver new perspective and debate on the topics facing the life sciences compliance industry, despite what some attendees described as a lack of new guidance, news or government policies in recent months. Each day of the conference was filled wall-to-wall with the type of keynote speeches, panel discussions and networking opportunities both experienced professionals, and newcomers to the field, need to consider as they strive to create and maintain compelling and effective compliance programs.

Thanks for reading,

Sean Murphy

About NXLevel Solutions

Through its PharmaCertify™ division, NXLevel Solutions helps life science companies build positive compliance cultures and reduce risk through innovative training and communication solutions. Our newest tool, TOVdisclosure.com, is a streamlined and intuitive site that enables manufacturers to share payments information with HCPs and HCOs before data is reported to CMS or other authorities. Contact us or visit TOVdisclosure.com for more information.

Week in Review, December 10, 2014

The Serious Fraud Office gains its first conviction under the U.K. Bribery Act, Sanofi is charged with kickback violations, and CMS unveils new tools and user guides in the Open Payments system.

Well, we’re smack dab in the middle of it now. There’s no escaping the mire, so just give in and go with the flow. The Christmas shopping season is in full swing. Daily Doorbuster specials, circling the mall parking lot repeatedly looking for a space to park…yes, the joys of the season are upon us. As you lick your wounds from another weekend of retail madness and mayhem, we offer a brief respite, with this week’s Compliance News in Review.

Gift giving is certainly a joy of this season, but you don’t want it to land you on the naughty list during an FCPA investigation. This list of ten tips to consider when giving business gifts can help keep a company on the nice list. Tips include making sure the gift is permitted under the local law where the recipients is based and recording gifts routinely in company books and records.

The Serious Fraud Office (SFO) has tied a bow around its first conviction under the U.K. Bribery Act. Two individuals were found guilty in a case that involved the sale of biofuel investment interests to U.K. investors. The defendants were found to have created fake invoices that allowed them to collect large commissions from the investors. Legal experts say the case makes it clear that the SFO will pursue individuals for private sector bribery.

Sanofi, its former CEO, and several other executives have been accused of overfilling the stockings of doctors, pharmacists and hospitals. A whistleblower suit, filed by a former Sanofi paralegal, claims she was fired when she raised concerns over several contracts that paid consultants to pass along kickbacks to doctors, pharmacies and hospitals. The kickbacks were allegedly offered in return for prescribing or purchasing the company’s diabetes drug. Former CEO, Chris Viehbacher said the accusations are “entirely baseless and are categorically false.” The company says it will vigorously defend the suit.

AstraZeneca and Ranbaxy won’t need to return the present they received in a pay-for-delay case. A jury decided that a deal between the two companies, which delayed a generic version of Nexium, was large and unjustified, but was not anticompetitive. A Ranbaxy spokesperson stated “the jury understood the facts of the case and was not swayed by wishful thinking on the part of the plaintiffs.”

CMS donned the Santa cap as it handed out several “gifts” last week for Open Payments users. The agency released an improved physician and manufacturer search tool, updated physician lists and revised user guides. CMS also announced it would soon provide reference information for the 2014 program year, including an overview of the timeline and updates on system enhancements.

If new commercial compliance training is on your holiday wish list, PharmaCertify™ from NXLevel Solutions, offers updated training on critical topics like global transparency, the Anti-kickback Statute, on-label promotion, and the False Claims Act. To see a demo of our eLearning modules and mobile apps, contact Sean Murphy at smurphy@nxlevelsolutions.com

That’s all for this week folks. Stay safe out there, and we’ll see you back here next week!

Week in Review, July 22, 2014

The Minnesota Board of Pharmacy confirms that payments to nurse practitioners and PAs must be reported, the FDA issues more Warning Letters, a grand jury indicts FedEx for shipping drugs for illegal pharmacies, and industry funding for CME continues to decline.

With summer in full swing, Major League Baseball took a break from the pennant races for its annual showcase of the best and brightest stars from both leagues…and the ratings were up. In what seems to be the trend lately, the American League came out on top and National League fans were left lamenting the fact that should their team make it to their World Series, they will once again be denied the coveted home field advantage (strange rule indeed). Now, as trade talks heat up and races tighten, we step up to the plate with this week’s News in Review.

First up, we have news from the state that hosted the All Star Game, Minnesota. The Minnesota Board of Pharmacy released a memo confirming that 2014 payments to nurse practitioners, physician assistants, veterinarians and dental technicians must be reported in May 2015. The Board advised manufacturers to begin tracking data for these professionals since it expected the legislature to require companies to report those payments.

Batting second this week is the always confusing topic of social media. The FDA recently issued an Untitled Letter to Gilead and a Warning Letter to Zarbee’s Naturals regarding the company’s use of social media for product promotion. In its letter to the company, the FDA cited an ad that used Google’s AdWords. The ad neglected to provide risk information, and the drug was misbranded. The ad also did not include the generic name of the product and only featured the brand name in a couple of URLs listed in the ad. Zarbee’s Warning Letter focused on the use of Facebook “likes.” The FDA equates “likes” top promotions and the company “liked” several customer testimonials on its page.

Companies that manufacture products for human use aren’t the only ones running afoul of the FDA’s promotion regulations. A Warning Letter was issued recently to the French pharmaceutical facturer, AB Science, for the off-label marketing of a veterinary drug. The letter cited several off-label statements on a product website. The FDA also noted that the company neglected to list important safety information on the product website and other promotional material.

The federal government took a swing at FedEx recently when a federal grand jury indicted FedEx for shipping drugs for illegal pharmacies. According to prosecutors, the company was warned for over a decade that they were shipping drugs for illegal pharmacies, but that those warnings went unheeded. Rather, the company “departed from its usual business practices” to continue shipping the drugs. According to prosecutors top managers at FedEx approved the continued shipping to known illegal pharmacies. A senior vice president for FedEx said the company was innocent of the charges levied against it, and would plead not guilty.

It’s a single for industry support of CME…a single digit decline in funding that is. According to the ACCME’s Annual Report, industry funding of accredited CME dropped by 1.9% in 2013. Support from industry represents 27% of all CME income. This is a far cry from 2008, when industry funding represented almost half of CME funding. Physician attendance at CME events was down in 2013 by just over 4%, but attendance by non-physicians was up by 5%.

As we wind down this week’s version of the Week in Review, we offer one last pitch about the importance of reviewing your Sunshine Act training needs – particularly in light of the ongoing activities around Open Payments registration and data review. The PharmaCertify™ eLearning module, The Sunshine Act: The Federal Physician Spend Disclosure Law, is designed to bring your team up to speed on reportable and excluded expenditures, and the information required for submission to CMS.

Have a great week everyone!