Reactions to DOJ Updates at PCF 2024

Empty conference room

It’s hard to believe that the PCF Congress was more than a week ago. But no sooner had we returned home and unpacked than we joined our clients in the annual sprint to get as much done before the holidays arrive and put the brakes on all our ambitions for 2024. So, before our Congress memories get swept away in the whirlwind, here are some things we took away from this year’s PCF.

The DOJ and AI. First and foremost, almost everyone was talking about the revised DOJ guidelines that came out in September. In the most recent version of its Evaluation of Corporate Compliance Programs (ECCP), the DOJ has made it clear that it expects companies to proactively manage the compliance risks of new technologies, especially AI. From what we heard at the conference, it doesn’t seem like many compliance professionals needed any prodding, as AI was discussed in multiple sessions, both as a source of new risks and as a tool that can increase the effectiveness of a compliance program. For example, one organization described how they have deployed an AI chatbot that employees can use to get answers to compliance-related questions.

Got Data? Along the same lines, AI can help compliance programs align with the revised ECCP’s emphasis on using data to identify and manage risks. “Is the company appropriately leveraging data analytics tools to create efficiencies in compliance operations and measure the effectiveness of components of compliance programs?” Here again, we heard from many compliance leaders who have already embraced data analytics as a way to mitigate such risks as HCP spending and third-party management. (Maybe because they jumped on board back when “big data” was the hot topic and AI was content to linger back in the IT department.)

A Culture of Compliance. The DOJ also expanded its guidance on whistleblower protections and the importance of anti-retaliation policies and practices. In the sessions we attended, this update was discussed in terms of creating a culture of compliance where employees feel safe to speak up. In one session on culture, there was also a discussion of the importance of speaking to your employees in their language, not the language of compliance. For example, when reminding sales employees that sign-in sheets are important for HCP meals, it might be good to mention they’re also a good way to capture new leads.

Tailored Training. One ECCP update that has not grabbed as many headlines is the DOJ’s insertion of this question in the section on Training and Communications, “Are the company’s training and communications tailored to the particular needs, interests, and values of relevant employees?” Once again, the compliance professionals we talked to at the Congress needed no convincing that targeted training is more effective than a one-size-fits-all approach. In this regard, the Congress had several engaging sessions that looked beyond commercial teams to discuss the unique compliance training needs of medical, clinical, and research personnel.

A Common Goal. Our last takeaway from PCF 2024 is that, although many of them work for competitors, there was a genuine sense of community among the attendees who encouraged and supported each other throughout the Congress. The life sciences compliance community is made up of an amazing group of diverse individuals who passionately share one goal: helping others do the right thing so patients can get the treatments they need.

And we at NXLevel Compliance are proud and excited to help them achieve this goal. We can’t wait for next year’s Congress.