On Tuesday, June 11, 2013, the Drug Enforcement Administration (“DEA”) announced that it had reached an $80 million civil settlement agreement, the largest in DEA history, with Walgreen Co. (“Walgreens”) to resolve allegations involving an “unprecedented number” of record-keeping and dispensing violations under the Controlled Substance Act (“CSA”). According to the DEA’s Press Release, Walgreens negligently allowed controlled substances, including Oxycodone and other prescription painkillers, to be diverted into the black market.
The settlement specifically resolves allegations involving the Walgreens Jupiter Distribution Center and six Walgreens retail pharmacies located in Florida. According to the press release, the settlement covers “at least tens of thousands of violations” of the CSA, including the following conduct:
As a result of these violations, the DEA stated that Walgreens pharmacies ordered and received at least three times the Florida average number of prescription painkillers such as oxycodone.
In addition to the $80 million penalty, Walgreens agreed to the following remedial measures:
This settlement represents the latest example of the DEA’s recent increased efforts to combat the pharmaceutical drug abuse epidemic. According to a recent report from the Centers for Disease Control and Prevention (“CDC”), the number of deaths resulting from prescription painkiller overdoses has more than tripled in the past twenty years, with overdoses accounting for more than 15,500 deaths in 2009. Accordingly, the DEA has been cracking down on the epidemic. The DEA reports that its efforts have resulted in the seizure of approximately 2.5 million dosage units of controlled substances, along with the surrender of DEA registrations by 192 doctors, 68 pharmacies, and seven distributors throughout Florida.
DEA Special Agent in Charge, Mark R. Trouville, warned in the press release that “[n]ational pharmaceutical chains are not exempt from following the law. This settlement sends a clear message that all DEA registrants will be accountable when they violate the law and threaten public health and safety.” Therefore, pharmacies should review their current controlled substance policies and practices to avoid DEA inquiry. For assistance with such a review or other compliance-related activities, please contact a health care attorney at Foster Swift.
Posted by: Johanna M. Novak, Julie C. LaVille (Summer Associate)