Cardinal's ongoing tussle with DEA over controlled-substances distribution

Federal judge asks DEA for show cause information; DEA claims millions of suspicious orders

After Cardinal Health’s Lakeland, FL, DC had its controlled-substances distribution license lifted on Feb. 3 (read back story here), and Cardinal obtained a temporary restraining order on the same day to continue operations, the regulatory dispute entered federal court on Feb. 13 under DEA’s standing process of enforcing distribution licenses. In the interim, DEA posted a news release claiming that two CVS pharmacies in Florida together had ordered over 3 million doses of controlled substances (mostly opioids) in 2011, while an average US pharmacy would order only 69,000. Also, Cardinal has been operating under an existing Memorandum of Agreement (MOA) since October 2008 (when a previous DEA enforcement action was finalized for that facility) and, in essence, should have known better.

The CVS pharmacies in question also sought, and won, temporary restraining orders against DEA. Two other pharmacies are apparently now without their controlled-substances licenses.

On Feb. 13, the federal judge asked DEA to provide more substantive information, with a deadline of Feb. 24. While contesting the DEA action, Cardinal issued a statement pointing out that “simple averages” of drug-ordering volumes are not a meaningful way to assess suspicious ordering patterns. “This one-size-fits-all approach oversimplifies the difficult and complicated process that is required of distributors that try to strike the balance Congress mandated between ensuring medications don’t fall into the wrong hands, while at the same time ensuring those medications are available for legitimate patient care.”