Sean Murphy, PharmaCertify
CBI’s 2013 Pharmaceutical Compliance Congress featured a compelling lineup of pharmaceutical and medical device professionals, as well as government regulators, who offered tips and best practices for managing the myriad of regulations and challenges that face those working in compliance for the life sciences industry.
Here are highlights from just some of the presentations and sessions at the conference.
Day 1, Keynotes
“Few will have the greatness to bend history; but each of us can work to change a small portion of the events, and in the total of all these acts will be written the history of this generation.”
Robert Kennedy (Quoted by Cynthia Cetani, Vice President, Ethics & Compliance and Chief Compliance Officer, Novartis Pharmaceuticals Corporation)
The theme of Day 1 was “change” and Cindy Cetani of Novartis opened the conference with details of how her company has embraced change through a campaign to humanize compliance with a clearer, more approachable process. That campaign has led to a clearer understanding of expectations and responsibilities throughout the organization.
After Ted Acosta of Ernst & Young focused his presentation on how compliance has evolved over the last decade, and moved beyond the “culture of compliance” approach introduced in 2008, Victoria Browning of Allergan welcomed the “next generation” of compliance officers and brought her own insight on the unique compliance challenges facing her colleagues in the medical device industry.
Judging by the reactions in the room, one of the real highlights of Day 1 had to be Dr. Michael Koren, the immediate past president of the Academy of Physicians in Clinical Research and a practicing cardiologist. Dr. Koren’s presentation, titled “Does Sunshine Act Shed Light or Blind Us?” offered a physician’s perspective on the law. His bewilderment over the concept of the government gathering data before anyone even knows what they are going to do with that data were highlighted by a humorous story from his recent trip to a conference in Munich Germany.
After one session at that conference, Dr. Koren was wandering the exhibit floor when a woman at the Pfizer booth offered him a Smoothie as a snack. When he said yes, her manager quickly appeared and announced that if the doctor was from the U.S., he would first need to complete an HCP Disclosure form indicating that he accepted the 4 ounce drink. Koren highlighted the absurdity of the moment with a photo of a sign next to the Smoothie machines informing attendees that healthcare providers from Minnesota were not permitted to accept the Smoothie. The ridiculousness of the experience was not lost on the audience.
Later in his presentation, Dr. Koren displayed his own profile on the Pro Publica website that lists the industry payments to HCPs, and explained how the data was confusing, misleading and unclear in its origin and intention. He then closed his comments by emphasizing that contrary to what seems to be the belief by the government, he wholeheartedly believes that physicians who have MORE relationships with our industry are better informed. His remarks certainly fell on a roomful of friendly ears.
Day 1, CCO Panel
The CCO Panel, titled, Insight and Improvements through CIA Implementation – Compliance Roundtable Takeaways, Ways to Maintain the Efforts, opened with Bert Weinstein of Purdue Pharma informing the audience that he had just received the letter officially closing out the company’s five-year Corporate Integrity Agreement (CIA). He followed the announcement by advising the audience that the OIG is looking for real integrity in compliance programs and for the industry to do a better job of policing itself. The panel then shared experiences of how they improved their compliance programs through the implementation of a CIA and how they see those programs changing once the CIAs are closed.
Sarah Richardson from Medicis stressed the common refrain of the importance of tone at the top and upper management’s participation in training. She also discussed the company’s multi-phased CIA compliance program, which concluded with a focus on adding value and making compliance a competitive advantage in Year 5. As proof of the success of that initiative, Richardson pointed out the Medicis is now recognized as one of the most ethical companies in the industry. And now, with those processes and policies in place, she considers the idea of moving into a post-CIA environment a “non-event.” Bert Weinstein agreed with that sentiment, stating that when the CIA ends, nothing should really change.
Alessandra Hawthorne from Boehringer Ingelheim focused on the importance of creating the right level of awareness as well as educating and informing colleagues around the world while Cinday Cetani of Novartis discussed the need to hire people who have extensive experience implementing a CIA and making sure a rigorous management certification process is put in place as part of that critical tone (and responsibility) from the top. Weinstein agreed, saying that he reports to the CEO and president of the company.
Day 1, Enforcement Panel
During the U.S. Healthcare Fraud Enforcement Activity – Trends and Top Priorities, a panel of U.S. Attorneys and regulators from around the country shared their thoughts on emerging areas of focus, such as clinical trials, research and development and medical affairs activities.
Timothy Heaphy, from the U.S. Attorney’s Office for the Western District of Virginia, talked about the Abbott settlement and how his office wanted to make sure there was a change to the corporate culture at Abbott and the Board of Directors at the company would be part of the on-going compliance certification. He also reminded the audience that voluntary disclosure is meaningful and has an impact when in the settlement.
Carmen Ortiz, of the U.S. Attorney’s Office for the District of Massachusetts emphatically assured the audience that all the settlements have had an impact over the years and she reminded the audience that as part of the GSK settlement, the company’s president had to certify that they were in compliance and any breeches would be reported.
John Walsh, from the U.S. Attorney’s Office for the District of Colorado said companies need to make sure their compliance programs are set up in a way that makes them sure that someone can jump in and say “you can’t do that” while Margaret Hutchinson, of the U.S. Attorney’s Office for the Eastern District of Pennsylvania, focused on third party vendors and the use of the Parke Doctrine in prosecutions.
Not surprisingly, the recent Caronia decision was a focus, and Rick Blumberg, from the Office of Chief Counsel, for the FDA, warned that those in the industry need to be aware that the Cronia decision only pertained to free speech and it is not a reason for companies to think the government’s focus on illegal activity around off-label promotion will stop.
Day 1, Product Promotion Track
During the Lessons Learned from Recent Enforcement Actions Related to Product Promotion session of the Product Promotion Track, attorneys, Michelle Axelrod and Jennifer Romanski from Porzio, Bromberg & Newman, P.C., covered the current best practices for the promotional review process through lessons learned in recent legal actions.
Track chairman, David Sandoval, of Sigma-Tau Pharmaceuticals, began the session by revealing the 2012 statistics around OPDP letters. In 2012, OPDP issued 3 warning letters and 25 untitled letters, with the warning letters being for more egregious violations. In addition, “misleading and unsubstantiated efficacy claims” were the violations most cited in the warning letters.
Axelrod and Romanski warned the audience to beware of special promotional challenges in their material like patient testimonials. Through the use of hypothetical scenarios, built around topics like disease awareness campaigns, they brought the potential risks and legal considerations associated with product promotion to light. They also addressed the risks of online media – pointing out that 12 of the letters issued in 2012 were for website promotions and 4 were for traditional media – broadcast or print.
The attorneys also addressed the Caronia case, saying the decision does not allow for the flexibility in off-label discussions by speakers. For example, the Merck letter was issues as a result of statements by speakers at a promotional program.
In the session focused on the role of compliance within the PRC structure, Alina Denis Jarjour, of Jarjour Legal, polled the audience on their roles in PRC. The trends in general, and in the room, showed that along with Medical, Regulatory, Marketing and Legal, compliance departments are playing more of an official role in PRC, with statistics showing:
- 33% play a direct role (with25% being advised of minutes/attending periodically and 8% sitting on PRC as voting member)
- 33% are consulted intermittently
- 33% have no involvement.
Jarjour’s case for compliance being on the PRC, was extensive and included the need to help mitigate the highest level of risk on the spot and provide the required checks and balances.
In the Compliance Considerations When Participating in an Alliance session, Rich Sparago and Greg Feller of Boehringer Ingelheim Pharmaceuticals used specific examples and case studies to highlight the strategies and tactics for driving alignment between two companies during an alliance. When covering the topics to consider when entering an alliance, Feller listed speaker training as the most critical. The two men suggested a first step of sharing SOPs to determine where business practices are the same and where they are different. At BI, they use a grid to note the similarities and differences, with a red/yellow/green coding system. Then, representatives from the two companies meet to review the grids and develop an action plan to drive alignment.
Day 2, Keynotes
After a brief review of Day 1 by Kris Curry of Johnson & Johnson, Mit Spears, Executive Vice President, Executive counsel for PhRMA, spoke about the ways in which companies, regulators and law enforcement can work together to ensure compliance. He started by reminding the attendees that “a culture of compliance is more than just choosing to avoid the law” and compliance can no longer be viewed as a one-off task, separate for other businesses.
Spears was blunt in his comments though, emphasizing that he is unsatisfied with the expectations placed on the industry by OIG and FDA and he is looking forward to engaging the agencies on the realities of the relationships between industry and healthcare professionals.
Following Spears, Sean McKessey, of the SEC’s Whisteblower office provided a detailed explanation of the purpose behind the formation of his office and the rules pertaining to how whistleblower rewards are determined and subsequently paid.
Thomas Abrams, from the FDA’s Office of Prescription Drug Promotion was next, with his annual presentation covering the efforts of his staff over the past year and their focus for 2013. No surprises here, with areas like policy development and labeling reviews continuing to be a focus. Abrams did provide a date for release of the Guidance on Social Media – July 9, 2014 – as indicated in Section 1121 of the new FDASIA bill signed into law last year.
Matthew D’Ambrosio, Senior Vice President, Chief Compliance and Ethics Officer at Sunovion Pharmaceuticals then presented on Issues to Consider when Implementing the New FDA Guidance. D’Ambrosio delved into the FDA’s guidance on unsolicited requests for off-label information, and shared Sunovion’s process for documenting the request and providing the supporting information in an appropriate and legal manner.
In the breakout session on Planning and Delivering Effective Compliance Training, Jill Bruzga, Senior Corporate Counsel, Global Programs Group at Pfizer touched on the tone from the top point and as an example of how to put that policy into practice, shared the story of Pfizer’s president delivering the first 20 minutes of a recent compliance training session. Bruzga also brought up the critical need to have a comprehensive communication plan for compliance training to notify the learners in advance, inform them why they have to take the training and establish deadlines for taking the training.
My coverage of the conference concluded with Compliance Strategies for Small to Mid-Sized Companies, featuring Timothy Ayers of Dendreon, Dan Best of Meda Pharmaceuticals, David Stollman of Incyte and Jon Smollen of Endo Health Solutions, who covered the challenges of managing compliance as a one or two-person department. While the panelists agreed that basically the risks are the same across the industry no matter the size of the company, they also agreed that they cannot approach compliance like a large organization and the key is to form allies throughout the company. As Dan Best pointed out, “compliance is still embedded in the business, that business just might be one person.”
Faced with the uneasiness of an industry in flux and on-going change, CBI managed to provide an anxious audience with two days of presentations that at least armed them with a range of useful tips and best practices to help guide them through turbulent times. Based on the reaction and participation of a grateful audience, the 2013 Pharmaceutical Compliance Congress certainly covered a list of well-targeted topics, from an impressive array of industry professionals, consultants and regulators.