ASCENT PHARMACEUTICALS, INC.
Inside DEA Compliance: Risk, Pressure, and Leadership
Cori L. Rizman
What Shaped the Compliance Leadership Approach
I’ve been fortunate to have leaders who modeled consistency, fairness, candor, and most importantly, approachability. Equally impactful were the experiences that showed me what I did not want to carry forward.
Some of the most formative moments came from navigating disappointment, mistakes, and outcomes outside of my control. During my time with DEA, I spent months—sometimes years—building cases, only to have them declined for prosecution despite being viable. It was difficult to accept the fact that effort did not always translate into outcome. That experience strengthened my resilience and reinforced the importance of staying focused on only what I could realistically control.
Working as a young female investigator in a predominantly male environment also shaped my leadership approach. There were moments of doubt—both internal and external—where my capabilities were questioned or my contributions overlooked. Rather than allowing that to define me, I leaned into my integrity and held myself accountable to my own personal standards. In addition to personal and professional growth, this forced me to recognize that my own personal validation was far more valuable than anyone else’s.
Leadership is not about being liked; it’s about being trusted.
Today, those experiences drive how I lead. I prioritize transparency, accountability, and doing the right thing—even when it’s difficult. Leadership is not about being liked; it’s about being trusted. That sometimes means having hard conversations or making tough decisions, but those moments ultimately define both the leader and the organization.
Major Compliance Challenges Facing Pharma Today
Two challenges continue to dominate the landscape:
1. DEA Quota Constraints
Controlled substance manufacturers operate within strict DEA quota allocations, which directly limit how much product can be manufactured. When demand shifts or supply disruptions occur, manufacturers are often forced into a reactive posture—seeking additional quota while balancing regulatory scrutiny, supply obligations, and potential shortage impacts.
Regulatory Engagement and Communication
Historically, there has been hesitation within the industry to engage openly with regulators, particularly the DEA, due to concerns of retaliation or reputational damage. Pathways for meaningful, solution-oriented dialogue have not always been clear and could still use improvement today. Bridging that gap remains a critical opportunity for improving both compliance outcomes and patient access.
Balancing Compliance with Operational Efficiency
Coming from a government background, I initially approached compliance in very black-and-white terms. Transitioning to industry required a shift toward risk-based decision-making.
Today, I focus on structured risk assessment—identifying potential risks, evaluating the likelihood of exposure, and understanding the potential impact. Not all risks carry the same weight. In some cases, a financial risk may be more acceptable, while in others, reputational risk is non-negotiable.
Operational efficiency comes from prioritization. It’s not about doing everything at once—it’s about focusing on the areas that matter most, aligning resources accordingly, and making informed, defensible decisions.
Trends Influencing Compliance and Risk Management
Customer due diligence, carrier oversight, and Suspicious Order Monitoring (SOM) continue to be central to compliance strategy.
Organizations are placing increased emphasis on understanding not just their customers, but the full supply chain ecosystem. Ensuring that customers and logistics partners have effective controls in place to prevent diversion is critical. This requires ongoing monitoring, data-driven insights, and a proactive—not reactive—approach to risk.
Building a Career in Regulatory Compliance
For professionals looking to build a career in regulatory compliance, my advice is to lead with integrity and empathy. If you can consistently make decisions that allow you to feel confident and accountable at the end of the day, you’re on the right path.
Compliance is not just about regulations—it’s about judgment, courage, and growth. If you stay grounded in that, your career will take care of itself.
