WASHINGTON – The Purdue Pharma Co., makers of the OxyContin prescription pain reliever, in a settlement with the Food and Drug Administration (FDA) on Thursday, agreed to pay over $700 million in fines to resolve charges and civil liabilities in connection with the misrepresentation of the drug to healthcare professionals.
According to an investigation by the FDA’s Office of Criminal Investigations (OCI), the drug company trained its sales force to represent OxyContin as a drug that did not cause euphoria and was less addictive than immediate-release opiates; and allowed healthcare providers to have the mistaken notion that OxyContin was less addictive than morphine.
Purdue Pharma also made false representations about the difficulty of extracting oxycodone, the active ingredient, from the OxyContin tablet, and labeled the drug as providing “fewer peaks and valleys than with immediate-release oxycodone,” the OCI said.
Purdue pled guilty to a felony count of misbranding a drug with intent to defraud and mislead.
Under the agreement, Purdue will pay a $600 million settlement, including a criminal fine, restitution to government agencies, and more than $276 million in forfeiture. In a separate civil settlement, Purdue will pay $100.6 million to the U.S.
Purdue’s current and former executives, Michael Friedman, Howard Udell and Dr. Paul Goldenheim, also pled guilty to a misdemeanor violation of misbranding OxyContin.
A statement on Purdue Pharma’s Web site said, “Nearly six years and longer ago, some employees made, or told other employees to make, certain statements about OxyContin to some healthcare professionals that were inconsistent with the FDA-approved prescribing information for OxyContin and the express warnings it contained about risks associated with the medicine. The statements also violated written company policies requiring adherence to the prescribing information. The misstatements were made prior to July 2001 and related to the risks of addiction, abuse, withdrawal, and tolerance compared to other pain medications. We accept responsibility for those past misstatements and regret that they were made.”
According to the statement, the drug company has implemented changes to its internal training compliance and monitoring systems to assure that such events do not happen again.
“In July 2001, we added amplified warnings to the prescribing information and communicated those warnings to healthcare professionals. Any attempt to connect the agreed to plea of misbranding by Purdue with abuse and diversion of OxyContin is completely false. The papers filed by the government do not make any such allegation and the company’s plea did not involve an admission of such wrongdoing,“ the statement continued.
Purdue Pharma also said that instructions for OxyContin, which are in the medication’s prescribing information and which were approved by the FDA, “have always contained express warnings and precautions about abuse, addiction, tolerance and withdrawal.”
Click here for the FDA report
Click here for Purdue Pharma’s statement on its settlement with the FDA
Click here for Purdue Pharma’s statement on its settlement with the FDA