Think compliance is just about ticking boxes? It’s time to reevaluate. The Department of Justice’s (DOJ) 2025 enforcement plan is shaking up the status quo, bringing individual accountability and faster investigations into sharper focus.¹
The DOJ’s heightened focus on individual accountability and expedited investigations is reshaping the enforcement landscape, urging compliance professionals (and the learning leaders who support them) to reassess their strategies and ensure their programs are responsive to an increasingly complex regulatory environment.² As trusted partners to life sciences organizations navigating global regulations, we believe this shift requires more than policy updates. It demands a fundamental evolution in how compliance is embedded into culture, training, and day-to-day decision-making.¹
DOJ’s new enforcement focus: What’s changed?
In 2024, the DOJ began emphasizing individual, not just corporate, accountability in cases of organizational misconduct. That focus continues to evolve in 2025—with the release of its White-Collar Enforcement Plan, which reinforces a commitment to faster investigations, greater transparency, and personal liability for decision-makers. As DOJ Criminal Division leadership recently noted, the plan represents “a new page in corporate enforcement,” aimed at creating a fairer, more efficient approach while maintaining pressure on those responsible for misconduct.²
The message is clear: individual accountability remains a cornerstone of federal enforcement strategy and compliance programs must be ready to meet that expectation. Senior leaders, managers, and even lower-level employees can no longer assume that corporate fines are the primary consequence of misconduct. Personal accountability is no longer theoretical—it’s a tangible risk for individuals at every level.³
This shift marks a critical turning point for compliance learning. Training is no longer a back-office formality but a frontline defense against personal legal exposure.⁴ Partnering with experienced training agencies can help ensure that compliance programs evolve quickly enough to keep pace with changing priorities.
The importance of culture and accountability at every level
To successfully navigate this shift, organizations must move beyond check-the-box compliance. The most effective pharmaceutical companies are already making culture, not policy, the cornerstone of their compliance strategy.⁵
However, the sheer complexity of today’s regulatory environment makes it difficult for in-house teams to stay ahead of the curve. That’s where training agencies can play a pivotal role in tailoring solutions that address both organizational culture and the nuanced risks facing different departments.
Compliance isn’t merely about following rules. It’s about creating an environment where ethical decision-making and personal accountability are integral to daily operations. A strong compliance culture involves:
Ethical decision-making at every level: Employees must recognize that their actions have consequences. Compliance should be deeply embedded in decision-making processes across all levels.
Personal accountability and transparency: Every individual must understand their role in upholding compliance standards and the implications of failing to do so. A transparent culture that encourages the reporting of misconduct is essential for mitigating violations.
Leadership commitment: Senior leadership must demonstrate a clear and consistent commitment to compliance. Their actions and communication should reflect a company-wide prioritization of ethical behavior and accountability.
Consistency in messaging and actions: This commitment to compliance should be visible in every department, from the boardroom to the front lines.
Embedding these values into company culture will not only reduce legal risks but also improve the organization’s ability to navigate complex regulatory landscapes effectively. Training agencies can collaborate with in-house teams to deliver role-specific training that brings these values to life and ensures that accountability is engrained at every level.
Elevating compliance through tailored training
Considering the DOJ’s new enforcement strategies, compliance training must evolve. Generic, one-size-fits-all modules will not prepare teams for today’s fast-moving risk environment. We’ve seen the greatest impact when pharmaceutical organizations embrace training as a tailored, role-specific experience and not a passive information overload.
Effective training programs should include⁶˒⁷:
Nuanced, situational training: The reality of compliance is rarely black and white. Employees must be equipped to navigate ambiguous situations, especially when legal guidelines are unclear. Training should address how to manage situations where the rules are not immediately clear, helping employees make sound ethical decisions.
Role-specific education: Different departments face unique compliance risks. For instance, commercial teams must be well-versed in regulations like the False Claims Act and Anti-Kickback Statute, especially when it comes to promotional activities, speaker programs, and HCP interactions. Medical affairs teams, on the other hand, may face compliance challenges related to scientific exchange and off-label communication. Customizing training to the challenges of each department ensures that employees can respond effectively to compliance concerns.
Reinforcing individual responsibility: Training should underscore that non-compliance can have legal consequences—not just for the organization, but for the individual. It should be made clear that executives, managers, and staff alike have a personal stake in maintaining ethical practices.
Regular updates: As the regulatory landscape continues to evolve, compliance training must be regularly updated to reflect new laws, emerging trends, and the latest enforcement priorities. Companies must be proactive, adjusting their programs as needed to ensure employees remain informed and prepared.
Prioritizing culture and training for future success
The DOJ’s renewed emphasis on individual accountability is reshaping the corporate compliance landscape, making it clear that personal responsibility is now at the heart of enforcement priorities. As the regulatory environment becomes increasingly complex, pharmaceutical organizations must recognize that compliance isn’t just about avoiding penalties, it’s about fostering a culture that values ethical decision-making and transparency at every level.
In highly regulated sectors like healthcare and pharmaceuticals, this shift presents an opportunity to strengthen internal practices, build trust, and create a sustainable foundation for growth. By integrating compliance and ethics into the fabric of organizational culture, companies can navigate these evolving challenges more effectively, while positioning themselves as leaders in responsible corporate governance.
As the regulatory landscape continues to evolve, the importance of proactive training and a consistent commitment to compliance will only grow. Organizations that prioritize these areas can not only minimize risks but also demonstrate their commitment to both regulatory excellence and broader social responsibility, setting the stage for long-term success.
Our advice? Start with the people. If your compliance programs haven’t been reviewed through the lens of individual liability and role-specific nuance, now is the time.
References
FCPA Professor. A focus on DOJ individual actions. Updated 2025. Accessed July 2025.
Skadden A, Slate, Meagher & Flom LLP and Affiliates,. Core False Claims Act Theories Top the List of DOJ Criminal Enforcement Priorities. Skadden Publication. Updated 2025. Accessed July 2025.
Harvard Law School. What DOJ’s new enforcement plan means for health care companies. Updated 2025. Accessed July 2025.
Society for Human Resource Management. Aligning learning and development with evolving workforce neds. Updated 2025. Accessed July 2025.
Sullivan & Cromwell LLP. DOJ announces white collar enforcement priorities and changes to relevant policies. Updated 2025. Accessed July 2025.
U.S. Department of Justice Criminal Division. Evaluation of corporate compliance programs. Updated 2024. Accessed July 2025.
Reuters. DOJ enforcement outlook in health care compliance for 2025. Updated 2025. Accessed July 2025.
