The InformaConnect Speakers Program Summit, held from February 26-28, 2024, at Hilton Penn’s Landing in Philadelphia, PA, served as a pivotal gathering for professionals in the life sciences industry. The Summit focused on the intricacies of developing and executing speaker programs that adhere to essential marketing, operations, and compliance practices.
DOJ Enforcement Forecasting and Priorities
One highlight from the event was the general session on Department of Justice (DOJ) Enforcement Forecasting and Priorities, which provided attendees with invaluable insights into regulatory trends and compliance strategies within the realm of speaker programs.
The session featured a distinguished panel, including Charlene Keller Fullmer, the Assistant U.S. Attorney & Deputy Chief & Affirmative Litigation at the US Attorney’s Office for the Eastern District of Pennsylvania; George Karavetsos, Shareholder, White Collar Defense, Compliance, and Investigations Practice Group Leader at Buchanan; and Jason Gould, Chief of the Health Care Fraud Unit at the United States Attorney’s Office for the District of New Jersey. These speakers brought a wealth of experience and expertise to the discussion, offering a comprehensive overview of the DOJ’s current enforcement landscape and priorities.
One key topic that was addressed during the session was the DOJ’s approach to speaker programs. Panelists emphasized that the government does not seek to hinder legitimate educational and communicative efforts with healthcare practitioners. However, concerns arise when programs offer incentives—such as payments, meals, and entertainment—that could influence medical decision-making, thus potentially violating anti-kickback statutes.
The panelists also delved into the March 2023 updates to the DOJ Criminal Division Evaluation of Corporate Compliance Programs, highlighting the critical role of corporate compliance in preventing healthcare fraud and abuse. This discussion underscored the evolving nature of DOJ enforcement, transitioning from focusing on off-label promotion and fraudulent claims to scrutinizing the compliance of speaker programs with anti-kickback statutes and the False Claims Act.
Throughout the session, the speakers shared insights and examples from their professional experiences, illustrating the DOJ’s multifaceted approach to identifying and prosecuting non-compliant activities. They provided practical advice for companies looking to mitigate risks associated with speaker programs, highlighting the importance of clear policies and procedures, diligent program monitoring, and ensuring that educational content remains the focus of these events.
Before concluding, the session distilled several key takeaways for attendees, emphasizing the critical nature of maintaining a balance between educational objectives and regulatory compliance in speaker programs. First, the panelists highlighted the importance of understanding the updated DOJ guidelines and the implications of the March 2023 updates to the DOJ Criminal Division Evaluation of Corporate Compliance Programs. It was clear that a nuanced approach to program execution, one that prioritizes educational content while carefully navigating incentives, is essential to avoid crossing ethical or legal boundaries. Furthermore, the discussion underscored the DOJ’s ongoing interest in speaker programs, especially those that potentially influence healthcare practitioners’ prescribing behaviors. To mitigate risks, the speakers advocated for the establishment of clear, robust policies and the implementation of rigorous monitoring systems to ensure adherence to compliance standards. Engaging in proactive communication and collaboration with compliance officers was also recommended as a strategy to preemptively address potential issues. These takeaways – among others – provided a roadmap for companies that wish to execute effective and compliant speaker programs within the life sciences sector.
In summary, the InformaConnect Speakers Program Summit’s session on DOJ Enforcement Forecasting and Priorities offered a comprehensive overview of the current enforcement landscape concerning speaker programs in the life sciences industry. Through a blend of regulatory forecasting and practical advice from experienced professionals, the Summit equipped companies with the knowledge to navigate the complexities of compliance, emphasizing the importance of ethical practices and educational integrity in their speaker programs.