The 12th Annual Pharmaceutical Compliance Congress provided an overflow crowd of rapt attendees with two days of best practices and updates on critical compliance-related topics. While the usual array of content was covered, the focus often turned to two key topics – Speaker Programs and the FCPA.
The conference kicked off with a keynote speech from Michael Shaw, Vice President and Chief Compliance Officer for GlaxoSmithKline. Shaw’s presentation was focused on the idea that instilling a culture of compliance is not enough in today’s regulatory environment. He emphasized the importance of ‘explaining the why’ behind the values, and the need to hold individuals accountable for compliance. As an example, at GSK, while Compliance is responsible for facilitating the process, Brand Directors are held accountable for managing the risk. As Shaw says, “compliance programs are important, but they’re not enough. The elements of the programs need to have traction.”
Otsuka ‘s Regina Gore Cavaliere and Brian Miller showcased their use of humor as a core tool for compliance training. Cavaliere and Miller have integrated a variety of creative elements, including a mock mini-series called The Pharm, comic books, and live talk shows, into their curriculum to keep the training fresh and appealing. Much of what was presented was indeed witty and engaging, and it showed that comedy can clearly be an effective tool when developed professionally and integrated carefully into a blended campaign.
In the Chief Compliance Officer Panel titled, Working with the Business – Ensure Compliance Adds Value to Operational Success, Jeffrey Rosenbaum from Vertex, Sujata Dayal from J&J, and Sumita Ray from Pharmacyclics, offered their perspectives on the keys to an effective program. With limited resources and time, Rosenbaum starts with his company’s business objectives while managing the issues with the highest risks. Ray agreed, saying she evaluates what risks she has to address on a daily basis, making training her first priority. As part of a large global company, Dayal begins with a formal risk assessment and conducts testing on a regular basis to ensure that mitigation is working. Rosenbaum also emphasized the importance of recruiting allies in the company when resources are stretched, as with Sunshine Act reporting, while Ray echoed Michael Shaw’s points about the importance of holding businesses accountable for their actions and results.
The presentations shifted to a governmental and regulator’s perspective with Doug Brown from CMS updating the audience on the state of Open Payments, a panel of US Attorneys addressing trends and top priorities in healthcare enforcement, and Andrew Ceresney, Director of Enforcement at the SEC covering disclosure issues relevant to the pharmaceutical industry.
What stood out during the enforcement panel was the increased amount of cases the regulators are seeing involving small to mid-size companies. Greg Shapiro, from the District of Massachusetts added that the audience should expect to see more criminal liability with those cases. Jacob Elberg, from the District of New Jersey encouraged those who identify a problem to self-report since “it sends the right message to employees and regulators.” More than one panel member delved into the risks of Speaker Programs, with Shapiro calling them “areas prone for abuse” and William Killian from Tennessee reminding the audience that Speaker Programs must not be tied to any promotion of business.
Ceresney covered the FCPA and the risks particular to the pharmaceutical industry. According to Ceresney, the SEC is focusing on three enforcement areas: pay to prescribe, pay to get on formularies, and charitable contributions. He emphasized the need for risk assessments and training, and the need to take measures when issues are identified.
After lunch, the sessions were divided into smaller groups, and I opted to stay with the FCPA theme in the session titled, Strengthen your FCPA Compliance through Smarter Training. David Nicoli, former VP, Corporate Affairs, AstraZeneca, and a panel of vendors walked through the steps they consider to be crucial when training on the FCPA. Collaboration is key, Nicoli claimed, and during his tenure at AZ he partnered on training initiatives with key allies, such as the Heads of Human Resources and Social Responsibility, who truly understand the work environment. The panel stressed the need for short, quick hits in FCPA training, and the fact that bad decisions make for good stories that stick in learners’ minds.
After the FCPA session, I jumped into the track dedicated to Product Promotional Compliance. Paul Silver from Huron presented statistics from a recent industry survey on company interactions with HCPs. For example, 86% of companies reimburse for HCP travel time and 1/3 of the companies surveyed have a limit on hotel expenses. Overall, the statistics presented a strong baseline for how the industry handles HCP travel time and I highly recommend the data for those interested in knowing what their peers are doing.
The session on overseeing the relationships between Sales, MSLs, and Managed Care Reps, was highlighted by one powerful statement from Kevin Stark, Director of GHH Compliance, at Merck, which could be considered a compelling theme for the entire conference, “build a culture where it’s okay for people to admit when they made a mistake.”
The second day opened with Tom Abrams of the FDA and his annual update on enforcement trends at the Office of Prescription Drug Marketing. In the area of policy and guidance development, OPDP has released six draft documents since January 2014, and three draft guidance documents on social media.
Abrams’ agency continues to allocate resources and priorities based on potential threats to public health. The most common violations over the past year were related to omission and minimization of risks, and unsubstantiated superiority claims.
Day 2’s enforcement panel, titled, A View from the Outside —Mitigate Risk and Prepare for the Future featured a panel of defense attorneys well-versed in the areas of risk for small and large pharmaceutical companies. Scott Lieberman of Loeb and Loeb stressed the need for sales representatives to know exactly how to handle off-label questions when dealing with HCPs. Matthew O’Connor, of Covington & Burling warned smaller companies to allocate enough resources to monitoring, an area often neglected. When asked about the relationship between Compliance and Legal, Allison Shuren from Arnold & Porter said Compliance should be the “boots on the ground, moving issues up the food chain,” and John Richter, from King & Spalding, noted that Compliance should be ‘setting the policy and evaluating the balance between costs and risks.’
I was particularly interested in the Life After a CIA — Impact on Internal Team Structures and Resource Allocation panel, so I attended the breakout session: Compliance Program Structure and Effectiveness.
Sujata Dayal, from J&J, stressed the need to continue the conversation between the businesses and Compliance but that dialogue needs to change as the role of the business shifts from one in which the businesses mandates company priorities to one in which they influence actions and decisions. Gregory Beeman, from Eli Lilly, said the first step was to see what can be streamlined and continued post-CIA. In other words, what was under OIG oversight that could be eliminated now that the CIA has expired?
In Successful Promotional Programs — How to Use Data Analysis & Market Research to Drive Compliant, Effective Results, Mark Dizon from Actelion, and David Gilman from Huron led a spirited discussion on the use of data and analytics to assess risks and results of Speaker Programs. The idea of whether Speaker Programs should be evaluated against Return on Investment was of particular interest as audience members and the panel members debated the merits and risks associated with acknowledgement of the ROI.
The final session I attended was focused on the challenges faced by small to mid-size businesses as they struggle to allocate compliance resources. The panel, consisting of Timothy Ayers of Porzio, Bromberg & Newman, Katrina Church of Merz North America, Jeff Rosenbaum from Vertex, Sarah Whipple from Aegerion, and Greg Moss from Kadmon, offered a diverse set of best practices based on their experiences with limited resources and time. The perspective offered by those who are literally ‘departments of one,’ and those, like Church from Merz, whose departments are growing rapidly, had enough content, suggestions, and tips to fill a conference unto itself. As one example, the panel and audience debated the benefits and challenges of live training versus eLearning. While live training offers the opportunity to work face-to-face with each trainee, which is easily achieved in very small companies, Church was quick to point out that as Merz grew, a shift to more eLearning, with its streamlined tracking, became a necessity. And, like their colleagues from larger companies, these participants emphasized the need to include the Board of Directors and the C-Suite in the importance of compliance training; and in getting buy-in at all levels of the company.
To sum up, the details brought forth over two days by many well thought out presentations and panel sessions in this year’s Pharmaceutical Compliance Congress offered veteran attendees and new comers alike a wealth of practical and impactful information, making attendance not only a good idea, but crucially important to staying abreast of new developments and best practices in life sciences compliance.