an individual doctor and pharmacy level. To more effectively and efficiently
combat this emerging law enforcement challenge, the DEA asked the drug
distributors to play a more proactive role in identifying, analyzing, reporting, and
blocking suspicious orders of controlled substances.
In 2005, the DEA started the “Distributor Initiative Program,” with the goal
of educating registrants on maintaining effective controls against diversion, and
monitoring for and reporting suspicious orders. DEA held individual meetings in
2005 and 2006 with McKesson, Cardinal Health, and Amerisource Bergen, and
instructed the companies on how to identify and submit reports of suspicious
orders. In 2006 and 2007, the DEA sent three letters to all DEA-registered
distributors to put them on notice about their legal obligations.
However, soon after the start of this initiative, each of these three companies
faced enforcement actions in 2007 and 2008 for failures to maintain effective
controls against diversion of controlled substances. Cardinal Health and
McKesson each paid civil penalties totaling millions of dollars.
Meanwhile, the opioid crisis worsened over the next decade, especially in
ravaged communities like the small towns in rural West Virginia.
Even after the 2008 settlements, while concerns rose over the opioid
epidemic, some distributors were still failing to exercise effective controls against
diversion. This led to more enforcement actions, and more settlements, including a
record-setting $150 million civil penalty by McKesson in January 2017. It remains
an open question today whether the distributors have finally achieved effective
DEA compliance programs.
Since the 1970s, you have had a statutory responsibility under the Controlled
Substances Act to exercise due diligence to report and avoid filling suspicious
