Key Takeaways from 2025 Pharmaceutical Compliance Congress

Trends in Life Sciences Enforcement

• • Enforcement of non-US anti-bribery regulations is active amidst the pause on Foreign Corrupt Practices Act enforcement. Continued reinforcement of company values and careful vetting of third-party relationships remains essential.
  • Scrutiny is increasing on marketing services firms potentially contributing to violations of the False Claims Act. Compliance should continue to question the origin of marketing ideas or practices that involve interactions with healthcare professionals or patients.

Top Considerations for Compliance Professionals

• • Compliance landscape involving diagnostic companies continues to evolve with reminders of Ultragenyx’s (a rare-genetic disease diagnostics manufacturer) settlement.
  • Patient assistance programs and free goods continue to be a focus given recent Office of Inspector General (OIG) advisory opinions.
  • Mitigate fines and penalties through an effective Compliance Program, but keep in mind that the credits apply only to criminal cases.
  • Ensure compliance policies and procedures, such as a Compensation Clawback Policy, allow compliance officers discretion in disciplinary actions.
  • Communicating Risk Assessment Mitigation Plan effectively to identify risk areas and establishing a feedback loop to enhance Compliance’s relationship with the Board of Directors is critical.

Artificial Intelligence (AI) at Life Sciences Companies

• • Governance structure and approach continue to be discussion points – no one-size-fits-all approach. Initial steps include developing an inventory of the varying types of AI initiatives and tools being used within the organization.
  • Consider developing an AI risk committee with representation from key stakeholders, such as medical, compliance, IT, legal, and regulatory.
  • Leverage the European Union AI Act and the National Institute of Standards and Technology AI Risk Management Framework as a foundation to develop AI governance strategies.