Being an exhibitor who also had access to all educational sessions and panels at the Twelfth Annual Pharmaceutical and Compliance Congress and Best Practices Forum in Washington DC offered me the opportunity to evaluate the conference from the perspective of a vendor, and as an attendee eager to absorb as much information as possible. As a vendor, I applaud the efforts of the PCF and the conference chairs to encourage attendees to visit the exhibit hall and explore the solutions offered by the various exhibitors. Throughout the conference, the foot traffic around our booth was high, and the compliance professionals we spoke with were genuinely interested in how our services and products could be utilized to support their training requirements. From an attendee perspective, I also appreciate the effort to schedule as many sessions as possible in the main ballroom, without concurrent sessions happening at the same time. The separate tracks, with the need to forgo some sessions in order to attend others, did not begin until the afternoon of Day 2, so everyone could take in ALL of the sessions until that point.
Of course, since I couldn’t attend all of the tracked sessions once they did begin, I welcome readers’ comments and commentaries on any I missed, or even on those I attended. With that, here are some of the highlights.
Day 1, Wednesday November 2, 2011
The highlights of Day 1 included the annual presentation by Mary Riordan, Senior Counsel for the OIG, who led off with the news that the OIG will be hosting a roundtable discussion in early 2012 for companies currently under a Corporate Integrity Agreement (CIA). The meeting is intended to allow the companies to share best practices for dealing with the compliance-related issues and a summary of the comments and suggestions will be posted on the OIG website following the meeting. Stay tuned for more details to come from the OIG on the roundtable session.
When reviewing the OIG’s 2012 work plan, Ms. Riordan reminded the audience that holding individuals, including board members and managers, accountable will continue to be a focus of the agency. She also emphasized the need for manufacturers to implement an active Risk Evaluation and Mitigation (REMS) program to address potential issues as early on as possible.
In a session titled, “Coordinating Pharma Prosecutions,” Joyce Branda, Director, Commercial Litigation Branch, US Department of Justice, updated the audience the audience on qui tam cases and informed the audience that there are currently in excess of 150 qui tam cases under seal and the primary issue is off-label promotion. As Ms. Branda put it, “For those of you who say off-label promotion keeps you up at night, it should.”
During his presentation, Thomas Abrams, Director, Division of Drug Marketing, Advertising, and Communications at the FDA, addressed the “hot topic” of social media guidance from the FDA. The FDA held a two day public meeting at which comments were accepted and the data was reviewed and considered in preparation of the guidance. Mr. Abrams informed the audience that guidance on social media will be based on the issues, not on the platforms. Stay tuned.
Day 2, Thursday November 4, 2011
Day 2 began with Kendra Martello, Assistant General Counsel for PhRMA, offering an update on the Sunshine Act. The bottom line – if you’re looking for any news on the CMS releasing the details regarding the procedures for submitting data, don’t hold your breath.
The Thursday presentation on the FCPA and the UK Bribery Act was particularly compelling considering the emphasis on anti-bribery prosecution by the DOJ and other regulatory bodies around the world. In case anyone forgot, Nathaniel Edmonds, Assistant Chief, FCPA Unit, US Department of Justice, told the assembled compliance professionals that the prosecution of individuals, including sales directors, is a stated goal of the DOJ. Vivian Robinson, Partner, McGuireWoods and Former General Counsel of the UK Serious Fraud Office, described the UK Bribery Act as the toughest anti-bribery regulation in the world and gave four reasons why:
- The regulation applies to both public and private companies
- It applies to the recipients of bribes as well as the individual offering the bribe
- It has no allowances for facilitation of services
- It creates a single offense – failing to prevent a bribe from taking place
Mr. Robinson pointed out that the UK Bribery Act does allow for a defense if a company can prove it has anti-bribery procedures in place and the Administry of Justice website lists the six principles required to demonstrate those procedures are in place.
Colleen Conry, Partner , Ropes & Gray, presented a thorough review of the well known “Lauren Stevens” case. Stevens, former in-house counsel for GSK was charged and ultimately acquitted of obstruction of justice and making false statements in connection with GSK’s response to a voluntary request from the FDA for information concerning the promotion of Wellbutrin. The key takeaways from the presentation included the importance of being transparent with all material no matter how irrelevant you think they may be and don’t assume the matter is closed if you don’t hear back from the FDA for many months.
In an afternoon session dedicated to the annual compliance administration survey by PricewaterhouseCoopers, Keith Korenchuk, Partner at Arnold & Porter, Erinn Hutchinson, Director at PwC and Victoria Browning, Senior Director, Corporate Compliance at Allergan, revealed some of the results of the survey. The topic of training was at the top of most respondents’ concerns as 74% of those surveyed said that education and training is where they spend most of their budget and time. The survey also showed the top five compliance areas of concern as:
- Sales and marketing
- Use of third parties
- Aggregate Spend
- Expansion to less established markets
I was happy to see the organizers and chairs of the conference created sessions dedicated to compliance for the medical device space. During a session titled, “Compliance Lessons Learned from Medical Device,” the challenges unique to the industry were reviewed by a panel led by Arjun Rajaratnam, Chief Compliance Officer at Smith & Nephew and Sujata Dayal, Corporate Vice President and CCO at Biomet. Gray areas like the questions surrounding a rep’s interaction with a surgeon using a device off-label in the operating room were debated and all agreed that the industry presents challenges very different than those in pharma, and professionals on the med device side need to be alert for the nuances.
Day 3, Friday November 4, 2011
On Day 3, we we’re all back in the grand ballroom and during a panel on the best practices for interfacing between third party vendors and client companies, Emma Boyev and David Young of Quintiles, joined Scott Miller of InVentiv and Don Soong of Cegedim to discuss topics that arise as sales teams are outsourced more and more. The panelists stressed that the days of vertically aligned pharmaceutical companies are over and among other topics, offered thoughts on how to organize training in areas like sample management when a third party relationship is in place.
Based on the comments from the attendees, one of the more anticipated presentations was Michael Loucks’ session title “Reflections on My Transition from Government Service to Private Practice.” Mr. Loucks, Partner, Skadden Arps and Former First Assistant US Attorney, shared emails and letters he received from those who felt he should be ashamed to now be representing the industry in compliance-related cases. No matter how one feels about Mr. Loucks, his practice or his opinions, his transition to private practice has certainly generated passion in the industry and with the public.
What I found to be the best presentation of the conference was saved for the last day and it wasn’t even focused on compliance in the pharmaceutical industry. Richard M. Mullane, former astronaut and Colonel, USAF, Retired, took the stage to offer his presentation titled, Creating a Culture of Compliance and Transparency: Lessons from the Challenger Disaster.” Colonel Mullane centered his discussion around what he referred to as the “normalization of deviance” and presented a clear step-by-step case for how the acceptance of short-cutting best practices that had been established early on led to the Challenger disaster. NASA had proof from earlier flights that the o-rings that failed on Challenger had failed in previous flights, but through rationalization brought on by budgetary and political pressure, repeated success of shortcuts in safety became the norm – with the tragic results we all witnessed being the result. Colonel Mullane left the audience with five tips for avoiding this normalization of deviance in dealing with compliance challenges:
- Realize that you are vulnerable
- Plan the work and work the plan (with allowances for situational awareness)
- When the heat is on, reference the plan
- Listen to the people closest to the plan
- Archive and review near misses
I could never fully explain the impact of Colonel Mullane’s comments in this blog, so I suggest if you ever have an opportunity to hear him speak, run, don’t walk. You can also visit his website at www.mikemullane.com to learn more about the man and his message.
Overall, as an exhibitor and an attendee, I was impressed with the Compliance Congress. The world of pharmaceutical and medical device compliance is changing rapidly and more than ever, well-organized and researched conferences such as this one are a necessary tool for sharing best practices, experiences and knowledge.