The FDA announced this afternoon a settlement whereby Purdue Frederick Company, Inc. has agreed to pay more than $700 million to resolve criminal charges and civil liabilities in connection with several illegal schemes to promote, market and sell OxyContin – cha ching.
According to the FDA Press Release –
An investigation by OCI uncovered an extensive, long-term conspiracy by The Purdue Frederick Company, Inc. to generate the maximum amount of revenues possible from the sale of OxyContin through various illegal schemes. To further this goal, Purdue trained its sales representatives to make false representations to health care providers about the difficulty of extracting oxycodone, the active ingredient, from the OxyContin tablet; trained its sales force to represent to health care providers that OxyContin did not cause euphoria and was less addictive than immediate-release opiates; and allowed health care providers to entertain the erroneous belief that OxyContin was less addictive than morphine. In addition, Purdue falsely labeled OxyContin as providing "fewer peaks and valleys than with immediate-release oxycodone," and by representing that "…delayed absorption as provided by OxyContin Tablets is believed to reduce the abuse liability of the drug."
The Company released the following statement:
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 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. The statement goes on to say that changes since then have been made to training programs to assure that there is no repeat.
There are a number of documents available at the site related to the settlement.