The 14^th Annual Pharmaceutical Compliance Congress featured an array of industry leaders, regulators, and legal consultants offering best practices, tips, and first-hand experiences related to reducing risk and strengthening compliance programs. This summary is focused on Day 1 of the conference, which featured a robust array of general sessions and breakout panels.

Pre-conference sessions were held the day before, and included Accelerated Learning — Healthcare Compliance and Policy Applications, which featured a panel of industry subject matter experts, including Dan O’Connor, Senior Vice President for PharmaCertify™, covering the topics those new to life science compliance need to understand in order to establish and maintain an effective program.

Luminary Session

The first presentation, Ignite and Infuse — Integrating a Compliant Culture within the Company’s DNA, featured three senior industry leaders, Beth Levine from Regeneron, Jim Massey of AstraZeneca, and Michael Shaw from GlaxoSmithKline offering compelling lessons on establishing successful compliance programs and the value of understanding “why they do what they do.”

Beth Levine shared the value principles she prioritized as she started building the department in 2008 when she was hired as the company’s first chief compliance officer. From the beginning, she emphasized the importance not having a “prosecutorial culture,” but one that was more “human, helpful, and empathetic.”

Jim Massey began his comments by recounting the recent United Airlines story related to the passenger being forcefully removed from a flight and the company’s public relations missteps in the immediate follow up. The core of the problem, as Massey saw it, was that United employees were strictly following rules and not making decisions for themselves.

At AstraZeneca, Massey and his team have instituted a true rules-based in which they “trust their people and not just the policies.” His goal was to simplify the policies as much as possible, so much so that the company now has a one-page Code of Conduct.

Michael Shaw followed in agreement, stating his belief that “complexity creates more risk rather than mitigating risk.” He used the example of speaker programs and the value of narrowing the policy down to kickback risks and communication risks.

The concept of a values-based approach to compliance has been discussed at length over the last ten years of the Pharmaceutical Compliance Congress, but this was the first time I heard the presenters offer such concrete and compelling examples and case studies of how their companies put the idea into practice. So much so that, throughout the day, other industry professionals and government regulators repeatedly referenced their comments to emphasize and highlight their own points. It was an illuminating presentation.

Elite Chief Compliance Officer Exchange and Fireside Chat

Next, compliance officers from Alexion Pharmaceuticals, Johnson & Johnson and Merck focused on data privacy and shared their thoughts on the proverbial question of “what keeps them awake at night.” For one presenter, that answer was tied to global risks (another common theme throughout the conference) and for another, it is more about the risks that “have not yet been identified” and that’s why regular risk assessments are so important. In a nod to representatives from smaller companies in the audience, that same presenter warned them not to over-engineer the risk assessments too much and to, “follow the money, and focus on the company’s business plan” to help identify the risks.

More than one presenter during the Fireside Chat stressed that while the data can be useful and powerful, “at the end of the day, it’s about respecting people’s privacy,” which relates to the values approached espoused in the first session. In the words of that CCO, “you need to think about what’s important, not just the process.” As another echoed, “don’t sit back and wait for laws and regulations, put in protections for providers and patients.”

U.S. Healthcare Fraud Enforcement Panel/Former Prosecutor’s Panel

The presentations shifted to the point of view of the industry as a panel of U.S. Attorneys took the stage for the Top Enforcement Trends and Focal Points for 2017 and Beyond session, which was blended with the former prosecutor’s panel, New Developments on High-Profile Cases and Settlements Uncovering Healthcare Fraud.

Unexpectedly, the discussion began with a sobering discussion about the opioid crisis in America, with disturbing statistics on the alarm growth of addiction rates and overdose deaths. It’s not a topic the audience necessarily expected, but it’s one that needs to be discussed, as regulators and the healthcare community seek answers to this frightening scourge that crosses all socioeconomic borders. The numbers are disturbing, and the panelists emphasized that “everyone is working together to figure out where the over-prescribing is coming from,” and “anyone involved in the distribution chain must have a program in place to help detect misuse and abuse.” They’re comments were punctuated by a reference to the recent McKesson case, in which the company paid $150 million to settle claims that it failed to put a system in place to detect suspicious orders.

A former US attorney offered a powerful suggestion when he called for the audience members to immediately and safely remove unused medications from their home, when they return from the conference, because “70% of people who start abusing opioids get them from someone they know, not a doctor.”

The two panels covered more traditional topics as well, and discussed the need for an active and strong compliance program. One presenter focused on smaller companies and warned of the risk of being too focused on being acquired to spent sufficient time on compliance. Not only is that a risk for the company itself, it should be a huge concern for any company interested in acquiring it. Another presenter touched on the familiar theme of “embedding yourself in the business,” as a method for ensuring the program is predictive and “risk-intelligent.”

The session closed with an important and hopeful comment from one panelist when he said, “what you don’t hear about are cases we decide not to prosecute because the companies have such robust compliance programs. That happens in all of our offices.”

Promotional Compliance

After the lunch break, I joined the Promotional Compliance content stream, which began with Tom Abrams of the Office of Office of Prescription Drug Promotion, and his annual Hot Topics, Guidance, Enforcement Trends, and Warning Letter Review session.

Tom detailed the recent Tuxarin ER warning, which focused on a series of troublesome product claims, including the suggestion that the product is safer than its competitors based on differences in dosing formulation and safety profiles of individual ingredients. He also provided a review of the recent Draft Guidance of Medical Product Communications That Are Consistent With the FDA-Required Labeling. The guidance explains the FDA’s current thinking on common questions about the topic and explains that the agency does not consider communications that are consistent with the FDA-required labeling to alone be evidence of a new intended use. A full list of recent warning letters and guidance documents are available on the FDA’s website.

During the First Amendment and Off-label – Caronia and Beyond presentation, Elizabeth Kim of Loeb and Loeb briefly touched on the history of the key cases over the years, and left the audience with key takeaways in terms of where we are now with off-label promotion as it relates to the First Amendment, including:

• FDA will continue regulate promotion, and there is no green light to promote off-label;
• Information can be truthful but still misleading in context, and;
• Transparency and full disclosure are key and includes the good and the bad in terms of how you promote.

She also touched on the recent Arizona off-label law knows as the Free Speech in Medicine Act. At least one institution, the Goldwater Institute, wants to encourage other state legislatures to consider similar legislation, but the law is federally pre-empted, so at this point, it is a symbolic step.

Conclusion

The panel sessions and presentations covered above represent only a portion of the guidance and valuable information offered throughout this year’s Pharmaceutical Compliance Congress. The conference is always chock full of content applicable to those new to the field of life sciences compliance, as well as experienced professionals seeking the latest in best practices, suggestions, and guidance from their peers, consultants, and regulators. This year’s agenda and presenters did not disappoint.

Thanks for reading.

Sean Murphy, Product and Marketing Manager