Virginia Attorney General McDonnell Announces OxyContin Settlement

States Reach $19.5 Million Civil Settlement with Purdue Pharma over OxyContin Marketing Practices; Virginia to Receive Nearly $1 Million

May 8, 2007 -- RICHMOND – Virginia Attorney General Bob McDonnell today announced that Virginia, along with 25 other states and the District of Columbia, has reached a civil settlement with Purdue Pharma L.P. and associated companies regarding the promotion and marketing of the pain medication OxyContin. The civil settlement addresses claims that Purdue engaged in extensive off-label marketing of OxyContin and failed to adequately disclose abuse and diversion risks associated with the drug in violation of state civil consumer protection laws. As part of the settlement, Purdue will pay $19.5 million to the states and adhere to numerous restrictions regarding the future marketing of OxyContin.

Virginia will receive $949,500 of the $19.5 million that Purdue will pay to the states. These funds may be used for consumer protection enforcement and education as well as for funding programs directed at combating prescription drug abuse, addiction or diversion, including education, prevention and monitoring programs. The Virginia Attorney General’s Office was one of seven that led the multi-state investigation.

“I am pleased that we were able to reach a civil agreement that sets appropriate parameters for the marketing of OxyContin,” Attorney General McDonnell said. “OxyContin has been particularly susceptible to abuse and diversion in Virginia, particularly in our more rural areas and Southwest Virginia. It is important that OxyContin’s legitimate medical uses be promoted in compliance with state consumer protection laws.”

Among other restrictions, the settlement prohibits Purdue from making any false, misleading or deceptive claim regarding OxyContin. The settlement also:

* prohibits Purdue from marketing OxyContin in a manner that is inconsistent with the FDA approved package insert for the drug;
* prohibits Purdue from misrepresenting OxyContin’s potential for abuse, addiction or physical dependence;
* prohibits Purdue from marketing OxyContin for “off-label” purposes – those beyond the FDA approved indications and usages for the drug;
* requires Purdue to have recipients of grants relating to OxyContin publicly disclose the existence of funding from Purdue in connection with any resulting study or research report; and
* prohibits Purdue from basing sales representatives’ compensation exclusively on the volume of OxyContin sales, and requires Purdue to take into account in performance evaluations of sales representatives that they inform prescribers about OxyContin’s potential for abuse and diversion.

The settlement also requires Purdue to maintain an OxyContin abuse and diversion detection program that Purdue established internally to identify potential abuse or diversion of OxyContin. Under the program, Purdue sales representatives are required to report prescribing activities that might indicate abuse or diversion of the drug. Upon identification of potential abuse or diversion, Purdue is required to conduct an internal inquiry and take further steps as may be appropriate, such as ceasing the promotion of Purdue products to the prescriber or reporting such potential abuse or diversion to medical, regulatory or law enforcement authorities.

The civil settlement is in the form of a Consent Judgment that has been filed with the Richmond Circuit Court for approval.

Source: Virginia Attorney General

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