Evidence in an opioid lawsuit reveals that instead of complying with DEA regulations, Cardinal Health took enforcement into its own hands.
A major drug distributor that is facing lawsuits for allegedly contributing to the opioid epidemic was warned as early as 2008 that it was not following protocol in reporting suspicious drug orders to the Drug Enforcement Administration (DEA), according to a document obtained during the discovery phase of those lawsuits.
According to NBC News, Cardinal Health hired a consultant in 2007 who had formerly worked for the DEA as chief compliance officer. The consultant warned the company’s lawyer that the firm was not in compliance with DEA regulations in regards to suspiciously large orders.
The DEA required firms to report any orders that were unusually large, frequent, or otherwise different from a customer’s established ordering patterns.
Instead of doing that, Cardinal Health took enforcement into its own hands. It established a cap for the amount of pills that could be ordered—three times the amount of a customer’s previous order. Although the company did not fill orders larger than that, it also did not report the large orders to the DEA.
“Customer orders that are in excess of three times the average (which would be the threshold) would be held for further investigation,” Ronald Buzzeo, the consultant, wrote to a lawyer for Cardinal Health on Jan. 23, 2008. “Orders that were held would be reduced to the threshold and sent to the customer. Delayed orders would be investigated. If the order was cleared of suspicion, the remainder of the order would be furnished to the customer. If the order was not cleared of the suspicion, the order would not be filled above the threshold limit; however, no report would be made to the DEA.”
Buzzeo pointed out that this did not meet federal requirements. Rather than taking this approach, the company should begin to “report all orders to the DEA that cannot be cleared of suspicion and cancel the entire order,” he wrote.
It’s not clear whether Cardinal Health took Buzzeo’s advice. However, the company was later fined $44 million for not reporting suspicious orders from 2009-2012, so it appears no major changes were made.
Cardinal Health said that Buzzeo’s letter was taken out of context. Hiring the consultant was an effort to meet the “significantly changing guidance” from the DEA about how large orders should be handled, the statement said. They insist that the company was in compliance with the Controlled Substances Act. The statement also claimed that the company has stopped millions of dosages by reporting suspicious orders to the DEA.
“Cardinal Health has learned from our experience and the threats the pharmaceutical supply chain faces, and as a result of the transition and a constantly adaptive approach, our anti-diversion program today is stronger and more effective as it continues to evolve,” the statement said.