Drug Manufacturer, CVS To Pay Millions For Failure To Comply With Controlled Substances Act
According to the U.S. Department of Justice, in a settlement, British drug manufacturer Mallinckrodt has agreed to pay fines to the tune of $35 million. This action comes as a result of allegations that the company failed to notify the U.S. Drug Enforcement Agency about unusually large orders for the opioid oxycodone made by pharmacies and pain clinics in the U.S. from 2008-2011.
The company admitted no wrongdoing, however, and stated that it had agreed to pay the fine to negate the “uncertainty, distraction and expense of litigation.”
Also, the government said that the drug manufacturer failed to accurately record the number of oxycodone tablets produced at a New York manufacturing facility.
Attorney General Jeff Sessions:
“Mallinckrodt’s actions and omissions formed a link in the chain of supply that resulted in millions of oxycodone pills being sold on the street.”
Prosecutors also stated that the settlement included an agreement with the DEA, which requires the company to examine data collected from customers down the supply chain to detect suspicious sales or activity.
“Mallinckrodt has agreed to do everything they can to help us identify suspicious orders in the future. And as a result of today’s settlement, we are sending a clear message to drug companies: this Department of Justice will hold you accountable for your legal obligations and we will enforce our laws.”
CVS to Pay $5 Million in Fines
CVS Health Corp has also settled on a $5 million fine in response to allegations that multiple pharmacies in California failed to identify and alert the DEA hydrocodone thefts, another opioid painkiller.
CVS issued the following statement:
“The Company agreed to settle this matter to avoid the delay, uncertainty, inconvenience and expense of protracted litigation.”
An investigation by the DEA that began in 2012 led to accusations that the DEA was not alerted to thefts or losses at five Sacramento-based pharmacies, as required by the Controlled Substances Act.
U.S. Attorney Phillip Talbert:
“National retailers that distribute massive amounts of controlled substances have a responsibility to comply with recordkeeping regulations because these regulations are specifically designed to prevent dangerous drugs from being diverted into the community and abused.”
CVS also agreed to a plan in which staff in 168 California pharmacies would be provided with improved training and monitoring.
CVS has been accused several times in the past for failure to comply with the Controlled Substances Act. In 2015, the company agreed to a $3.5 million fine in response to accusations that 50 Massachusetts and New Hampshire pharmacies filled fraudulent prescriptions for opioids.
The year before, CVS paid $22 million following the discovery that two Florida pharmacies were regularly filling fraudulent prescriptions for opioids, and back in 2010, CVS was fined $75 million by the DEA for improperly selling cold medications in Nevada and California.
~ G. Nathalee Serrels, M.A., Psychology