Pharmaceutical distributors, like AmerisourceBergen, are required by law to monitor the orders that they receive from pharmacies and other customers and report suspicious orders to the Drug Enforcement Administration (DEA). “Our complaint alleges that AmerisourceBergen, which sold billions of units of prescription opioids over the past decade, repeatedly failed to comply with that requirement,” said Associate Attorney General Vanita Gupta.
According to the DoJ’s complaint, filed Dec. 29 in the U.S. District Court for the Eastern District of Pennsylvania, AmerisourceBergen violated the Controlled Substances Act (CSA) from 2014 through the present “by failing to report at least hundreds of thousands of suspicious orders of controlled substances to the DEA.” This includes “filling and failing to report numerous orders from pharmacies that AmerisourceBergen knew were likely facilitating diversion of prescription opioids,” the DoJ said.
The DoJ’s complaint cites several specific instances of AmerisourceBergen allegedly ignoring red flags that suggested prescriptions drugs were being diverted to illicit markets. Examples cited in the complaint include:
- Two pharmacies, one in Florida and one in West Virginia, for which AmerisourceBergen allegedly knew its distributed drugs were likely being sold in parking lots for cash;
- A New Jersey pharmacy that pleaded guilty to illegally selling controlled substances;
- Another New Jersey pharmacy whose pharmacist was indicted for drug diversion; and
- A Colorado pharmacy, the state’s largest purchaser of oxycodone, in which AmerisourceBergen specifically identified 11 patients as potential “drug addicts” whose prescriptions likely were illegitimate. Two of those patients subsequently died of overdoses.
The DoJ’s complaint further alleges that AmerisourceBergen’s internal system to monitor and identify suspicious orders were “deeply inadequate, both in design and implementation,” and, thus, “flagged only a tiny fraction of suspicious orders.” Moreover, the complaint alleges this misconduct was intentional. “AmerisourceBergen intentionally altered its internal systems in a way that reduced the number of controlled substances reported as suspicious. Even for the small percentage of orders that AmerisourceBergen did identify as suspicious, the company routinely failed to report them to the DEA.”
If found liable, AmerisourceBergen could face escalating civil penalties, depending on when each violation occurred and the type of controlled substance at issue, potentially totaling billions of dollars. According to the DoJ, potential penalties could reach upward of $10,000 for each reporting violation that occurred before November 2015; $16,864 for each violation that occurred between November 2015 and October 2018 and for each violation relating to a suspicious order for a non-opioid controlled substance not reported after October 2018; and $109,374 for each violation relating to a suspicious opioid order not reported after October 2018. 
Jaclyn Jaeger is a contributing editor at Compliance Chief 360° and a freelance business writer based in Manchester, New Hampshire.