Dozens of recent articles have attempted to deconstruct the root causes of the opioid epidemic, asserting that the pharmaceutical supply chain failed to recognize a growing crisis as it was happening. What these stories gloss over is the role of the supply chain’s regulatory body, the Drug Enforcement Administration (DEA). The DEA has myriad regulatory tools and enforcement avenues at its disposal, which were underutilized in the midst of a growing opioid abuse crisis.
DEA Set Manufacturing Quotas
There was significant attention to the fact that 76 billion opioid pills were distributed across the nation from 2006 to 2012, a fact which several media outlets presented as sensational breaking news.
Given the DEA production quotas, the number shouldn’t have been surprising at all.
Production quotas are approved annually by the DEA and published on the agency’s website. During this time period, the DEA quotas permitted the manufacture and distribution of nearly 1 trillion milligrams of oxycodone and hydrocodone—with an average strength of just under 7.5 milligrams per pill (as revealed by the ARCOS, Automated Reports and Consolidated Ordering System, data), that’s enough to create 130 billion pills.
Experts have highlighted that the DEA production quotas reduced supply of amphetamines in the 1970s by 90% and then similarly cut Quaalude production by 74% in the 1980s, drastically impacting abuse issues with those substances.
What’s interesting is that during the 2006 to 2012 time period, the actual supply of opioids distributed amounts to just 57% of the DEA-established quotas. Breaking it down even further, my company’s shipments during this period amounts to only 4.8% of DEA’s opioid quotas. Yet the DEA raised opioid quotas annually for decades, only beginning to reduce them in 2016.
In fact, Sens. Kennedy (R-La.) and Durbin (D-Ill.) issued a public letter just last week, urging the DEA to utilize its increased authority granted by the Opioid Quota Reform Act of 2018 to adjust opioid quotas to reflect diversion, overdose deaths and public health. The letter chided the agency’s previous increases, stating, “between 1993 and 2015, DEA allowed aggregate production quotas for oxycodone to increase 39-fold, hydrocodone to increase 12-fold, hydromorphone to increase 23-fold, and fentanyl to increase 25-fold.”
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Licensing and Registration
Every pharmacy in the nation that dispenses controlled substances must maintain a DEA registration. In fact, all orders from pharmacies to distributors for opioids are placed in a DEA-managed web portal called Controlled Substance Ordering System (CSOS) to ensure that the pharmacy requesting to purchase opioids has an active registration with the DEA. However, that registration system doesn’t seem to be used for data analytics or to identify potentially bad actors.
That means pharmacies had an active license with the DEA while they were receiving the opioids they ultimately dispensed. State Boards of Pharmacy also license every pharmacy and are yet another safeguard against bad actors, meant to protect the public health and safety of each state.