Sean Murphy, NXLevel Solutions
The first day of the Fourteenth Annual Regulatory and Compliance Congress and Best Practices Forum opened with a roundtable session featuring chief compliance officers from Eisai, Shire, Merck, Bristol- Myers Squibb and Purdue Pharma. Analytics and data were the primary themes and Anne Nielsen from BMS emphasized the need for companies to use data to spot the trends and the risk areas for compliance. Eve Costopoulos from Eisai agreed, noting that a coordinated effort addressing risks is crucial and web-based tools should be put into place to collect the data. Caroline West from Shire shifted the conversation to the importance of having a serious conversation with the sales force about what they can and can’t do and Eve suggested that the level of understanding among the sales team may not be what the audience of compliance officers believed it to be.
Mary Riordan, Senior Counsel to the Office of Inspector General was next with her annual OIG Update presentation. She began with an update on enforcement activity from the previous year and in particular, the large number of kickback cases, including the Sanofi Hyalgen case, the Boston Scientific/Guidant case and the Purdue Frederick case.
Riordan also stressed that promotional activities need continued scrutiny to be sure what messages are being conveyed and as in years past, she suggested the compliance officers look to recent CIAs for lessons. She specifically referenced the Par CIA and its recoupment program. And in agreement with the comments made by the chief compliance officers on the preceding panel, Riordan said the risk assessment process was a good way to bring businesses into compliance efforts and ensure an effective process.
Next on the docket was the Assistant US Attorney Roundtable with representatives from New York, Boston, Philadelphia and Los Angeles in attendance. Margaret Hutchinson of Los Angeles echoed earlier comments, saying that when investigations are conducted, her office focuses on the time period from when the company learns of a problem to when that company acts on the problem, while Paul Kaufman from New York urged the audience to consider their personnel, claiming that he has seen good compliance departments staffed by people who “really don’t know what they’re doing.” He also suggested that incentivizing employees on sales may lead to more compliance issues and offered the idea of taking away bonuses if employees violate compliance regulations.
Tom Abrams, Director of the Division of Drug Marketing, Advertising, and Communications for the FDA returned this year to speak to an audience anxious to hear his FDA-OPDP Update, especially the status of the agency’s guidance on social media. While Abrams did commit to providing guidance that will be high in quality and relevant, which was stated with a disclaimer that his office was limited in resources, he did not commit to meeting the deadline set forth in the Prescription Drug User Fee Act (PDUFA).
Abrams also updated the audience on the FDA’s Bad Ad program, and the most common violations found over the last year. Omissions of risk, misleading efficacy and misleading superiority claims led the pack in terms of those violations.
Mit Spears, Executive VP and General Counsel for PhRMA closed the first day with a keynote presentation that mostly amounted to a compelling argument in defense of promoting off-label. Spears’ points on the frequency of off-label use and the potential benefit to patients were not lost on an audience that was sure to agree with his thoughts. Unfortunately, the regulators who presented earlier in the day were most likely no longer in the room.
The second day of the conference opened with a panel session of industry leaders and an interactive dialogue that included audience response questions designed to gauge compliance priorities and readiness.
When asked about their top priorities, 41% of attendees answered “improving compliance systems and processes,” and “aggregate spend and Sunshine” was the second most popular choice. On the subject of their top global issues, the audience cited “FCPA/Anti-corruption” as their primary concern. Kelly Freeman, Senior Director of Ethics and Compliance at Eli Lilly, took the opportunity to remind attendees that they can no longer just focus on the FCPA and the UK Bribery Act – anti-corruption in globally needs to be the focus of their training.
On the question of which area of aggregate spend they are most worried about implementing, 60% of the audience answered, “accuracy of data.” The panelists pointed this to the biggest benefit of the Sunshine Act – the data is critical and helpful. Kris Curry, formerly of Johnson & Johnson, issued a warning not to spend too much effort and too many resources on the smallest details.
On the question of whether their companies regularly assess employee perception about compliance culture, 62% of the audience answered yes, which was definitely considered a positive trend by the panelists.
Speaking of trends, when asked about the background of their compliance staff, audience members said 40% had a legal background, 16% came from the sales and marketing function, and the remaining staff was spread across a number of disciplines.
During the session covering the View from the C-Suite, panelists Jean-Luc Fleurial of Bristol-Myers Squibb, Adrienne R. Takacs of Takeda and Michael Goolsby of Fresenius Vascular Care, agreed that compliance has to start in the hiring process. Goolsby advised those in a hiring role to look for employees who bring integrity coupled with coachability. He also touched on the training process, stressing that training needs to extend beyond the check-the-box approach recognizable to real-world scenarios.
The second half of Day 2 featured a series of “mini summits” in topics as diverse as third party relationships, government pricing, data sharing and cGMPs. I was anxious for an update on the FCPA and UK Bribery Act so I started with the Anti-corruption Update session with a panel of experts, including Nathaniel Edmonds, Former Assistant Chief, FCPA Unit of the DOJ and Vivian Robinson, Former General Counsel of the UK Serious Fraud Office. In noting that while there have been no significant UK Bribery Act cases to date, Robinson reminded the audience that the law had not been in place long and he was aware of “a number of cases on the books that were likely to come into the public domain in a short time.”
Edmonds focused on recent trends in FCPA enforcement and in particular, Fair Market Value and the importance of proper methods for reimbursing CROs and other third parties. Robinson agreed that third party due diligence is essential but warned that the focus on gifts and entertainment can be a distraction from that third party focus.
China was of course a topic of discussion with so much anti-corruption news emanating from the country in recent months. Edmonds called China “one of the most important recent developments for the pharmaceutical industry” and Robinson emphasized the need for clearly recorded due diligence, “you can say what you did and back it up.”
After a disappointing start to one of the late afternoon sessions, which started more as an advertising opportunity for the companies presenting, I joined a number of other attendees in moving to the Interplay between Company Culture and Compliance, where the key message seemed to be the importance of emphasizing the positive when evaluating employees. Or, as Gina Dunsmuir from Ortho Clinical Diagnostics said, “give the employees examples of what they are doing right.” Tom Costa from Bristol-Myers Squibb believes employees “want to be proud of their corporation,” and that’s even more reason why compliance officers need to be out in the field listening to employee feedback.
I decided a dose of medical device compliance would be a good way to close Day 2, and took in the Medical Device Compliance Issues Update session with Paul Kalb of Sidley Austin, Seth Whitelaw of Deloitte & Touche, and Sandy Kalter, Chief Regulatory Counsel for Medtronic. The panel pointed to the trend toward more med device CIAs and the increased focus on executive management and directors in those CIAs. For example, in 2012, of the $260 million dollars collected in anti-corruption fines, $50 million was from three device companies.
For Kalter, the biggest priority is managing off-label risks by first studying recent CIAs and developing a policy around the results. The different areas where off-label arises are key, according to Kalter, including areas like consultative meetings and MSL interactions.
Day 3 opened with a keynote presentation from Bret Saunders, the new CEO of Forest Laboratories who was once a compliance officer for Schering-Plough. Saunders offered a unique view on how he perceives compliance from the CEO role. He believes “integrity includes compliance, yet goes beyond to include following your moral compass.” It took three days, but I knew I’d hear a reference to “tone at the top” and Saunders didn’t disappoint. But he used the oft-quoted phrase effectively, stressing the need for that tone to be communicated from the Board.
Understanding the background of his audience, Saunders included tips for presenting compliance concepts to directors. For example, keep concepts clear and in perspective. These are often people who don’t know the industry, so the information has to be right and it has to be organized. He advised the CCOs to approach their role as in a way in which they understand what the organization is trying to accomplish and which risks have the most impact on business. The best way to measure compliance readiness is to repeatedly survey internal and external stakeholders, according to Saunders, and conduct focus groups with employees to reveal how they feel about compliance and the related issues.
After an intriguing presentation on the role of unconscious biases in everyday life by Shankar Vedantam, NPR Correspondent and author of The Hidden Brain, and two panel discussions covering topics as diverse as Sunshine, state laws and lessons learned by attorneys who formerly worked in public service, Arun Sharma, from the University of Miami closed the conference with his take on the future of compliance. PCF planners may have made a mistake in scheduling Sharma for the last session because his comments were some of the most compelling and certainly controversial ones made during the conference. Leave it to academia to think outside the box and challenge the audience to approach compliance as a strategic opportunity to enhance marketing opportunities. The audience that hadn’t left for an early train or flight stirred uncomfortably as Sharma emphasized that “compliance 2.0” should be viewed as a chance to enhance a brand and grow that brand within the letter of the law. He challenged those audience members to be “more creative within the rules.” During a follow up question and answer session, one remaining audience was grateful for Sharma’s unique ideas but lamented the fact that government regulators hadn’t stayed to hear the presentation because he was sure they would disagree with the approach.
While some attendees anecdotally expressed frustration over the lack of new information presented at the Fourteenth Annual Regulatory and Compliance Congress and Best Practices Forum, conference organizers continue to seek new and innovative methods, e.g., mini summits, to present an ever-evolving stockpile of information to an eager audience. The conference, along with CBI’s Pharmaceutical Compliance Congress, remains the premiere opportunity for the industry to share the latest best practices and concepts.
See you at PCC in January!