“settles concerns about off-label marketing of narcotic pain medication OxyContin”

Attorney General Hardy Myers today filed a stipulated general judgment in Marion County Circuit Court with Purdue Pharma L.P. of Stamford, Connecticut resolving allegations by the Oregon Department of Justice and 25 other states and the District of Columbia that the company engaged in extensive off-label marketing of the narcotic pain medication OxyContin. Named in the judgment were Purdue Pharma L.P. and Purdue Pharma, Inc., doing business as Purdue Frederick Company.

The settlement also resolves allegations that Purdue failed to adequately disclose abuse and diversion risks associated with the drug OxyContin, a time-released, Schedule II opioid, used for pain management of moderate to severe pain over an extended period of time in violation of Oregon and other states’ respective consumer protection statutes.

“Purdue’s marketing practices of OxyContin were excessive and possibly abusive,” Myers said. “Oregonians must be protected from pharmaceutical companies that make false and deceptive claims about any drug in order to increase sales beyond the approved indications and uses of the drug but especially a narcotic.”

Under the judgment, Purdue must address those marketing practices believed to have been excessive or abusive. The settlement further requires Purdue to maintain an abuse and diversion-detection program that the company established internally to detect problem prescribing, and requires all field personnel to undergo training on the program before being allowed to promote OxyContin.

Among the restrictions and requirements contained in the settlements are provisions that Purdue must:

• market and promote OxyContin in a manner consistent with its package insert and not in a manner that minimizes the approved uses for the drug;
• not market or promote OxyContin for off-label purposes – those beyond the approved indications and uses of the drug;
• have any recipient of funds or other remuneration for grants publicly disclose the existence of that remuneration;
• not sponsor or fund any educational events where Purdue has knowledge at the time the decision for sponsorship or funding is made that a speaker will recommend the off-label use of OxyContin;
• not exclusively base Purdue sales representatives’ bonuses solely on the volume of OxyContin prescribed; and
• take into account, in the performance evaluations of sales representatives, their educating prescribers about OxyContin and its potential for abuse and diversion.

In addition to the requirements to market and promote OxyContin only in line with FDA-approved uses, and formalizing the “OxyContin Abuse and Diversion Detection Program,” the settlement prohibits Purdue from making any false, misleading or deceptive claim regarding OxyContin.

Finally, the settlement provides for a monetary payment by Purdue of $949,500 to the Oregon Department of Justice Consumer Protection and Education Fund and other Executive Committee states with active participant states each receiving $719,000 and the other states $500,000 each.

Joining Oregon in the investigation of Purdue’s business practices and today’s settlement are Attorneys General from the states of Arizona, Arkansas, California, Connecticut, Idaho, Illinois, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Montana, Nebraska, Nevada, New Mexico, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Vermont, Virginia, Washington, Wisconsin and the District of Columbia.

Consumers wanting information about consumer protection in Oregon may call the Attorney General’s consumer hotline at (503) 378-4320 (Salem area only), (503) 229-5576 (Portland area only) or toll-free at 1-877-877-9392. The Oregon Department of Justice is online at www.doj.state.or.us.