Opioid Manufacturers and Distributors Allegedly Fail to Report Suspicious Sales Activity


Drug Enforcement Expert WitnessThis is a case against distributors & manufacturers of opioids for, among other things, the violation of the Controlled Substances Act. Under the Controlled Substances Act, distributors are responsible for ensuring that opioids aren’t distributed and sold under suspicious circumstances, i.e. a closed loop system. The defendants are alleged to have not monitored the sale of drugs and did not report suspicious circumstances regarding their pharmacy customers. These distributors have been fined repeatedly for violating the CSA. We require an expert who is familiar with DEA diversion investigations to discuss the process and opine on how pharmacies attempt to avoid these investigations and continue to enable the opioid epidemic.

Question(s) For Expert Witness

  • 1. Please briefly describe your experience with the DEA.
  • 2. Can you speak specifically to diversion investigations? Do you have experience with opioids in this context?

Expert Witness Response E-007703

Expert-ID: E-007703

The DEA is required to establish and maintain a closed system of distribution for the Importation, Manufacturing, Distribution, and Dispensing of all controlled substances. The system is designed to provide accountability for all controlled substances from start to finish. The DEA is also responsible for placing quotas and restrictions on all products that enter the United States as raw materials for production, security measures imposed on distributors, and the dispensing to the end-user. The DEA, and more specifically, the Office of Diversion Control, enforces the Code of Federal Regulations that is consistent with the Controlled Substance Act of 1970. The DEA maintains that all entities who either purchase or prescribe controlled substances be registered with the DEA. Each registered entity must be in compliance with rules they must be followed in order to maintain an active registration. Registrants who don’t comply face Administrative, Civil, and/or Criminal Sanctions. For example, Pharmacists have a corresponding responsibility and must only fill valid prescriptions for controlled substances issued by a legitimate practitioner for a legitimate medical purpose.

Expert Witness Response E-138166

I worked for DEA as a diversion investigator (DI) for 28 years. During those years, I worked as a field investigator, DEA staff coordinator at HQ, diversion group supervisor, acting diversion program manager and diversion group supervisor as well. As a DI, l worked on criminal, civil and regulatory investigations, which involved scheduled 2-5 controlled substances. Nine times out of ten, manufacturers don’t sell directly to pharmacies. Instead, they sell to distributors. All parties (manufacturers, distributors and pharmacies) must inform the DEA regarding suspicious activities to initiate a case. However, during my time at the DEA, we would receive tip-offs of instances in which the distributors didn’t report back to the manufacturer. In my capacity, I would routinely investigate companies, check records, and account for controlled substances and suspicious activities.

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