The FDA Group's CEO, Nick Capman sits down with former DEA agent Dennis Wichern to discuss the vital role of compliance for pharmaceutical companies dealing with controlled substances and the significance of adhering to DEA regulations.
Key discussion points include:
» The importance of strong compliance programs, record-keeping, and suspicious order monitoring systems, especially in light of the nationwide opioid lawsuits.
» Common issues faced by DEA registrants, such as poor record-keeping and security, and the need for adequate security measures and compliant record-keeping systems.
» The process of determining a buyer's legitimacy and the reasonability of their controlled substance purchases, with suggestions for due diligence, background checks, and evaluating the balance between controlled and non-controlled substances.
» The focus of DEA inspections on large manufacturers and distributors, and Dennis's work with pain providers, pharmacies, hospitals, and small distributors when problems or fears of DEA intervention arise.
» Mock inspections and tips for interacting with the DEA to help clients prepare for real inspections.
» Dennis's experience as an expert witness in opioid lawsuits and the interactions between DEA and FDA, highlighting the different authorities of the two agencies and their collaborative efforts in determining drug schedules.
Dennis is the former Special Agent-in-Charge of the Chicago, Illinois regional office of the U.S. Drug Enforcement Administration (DEA). He offers clients over three decades of federal law enforcement experience as well as a keen understanding federal agencies and working relationships with all major federal agencies, the U.S. Sentencing Commission, Assistant U.S. Attorneys, U.S. Attorneys, and other Department of Justice officials.
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