Multistate Settlement Reached With Purdue Pharma For OxyContin Advertising Practices

26 States and D.C. Address Concerns with Purdue Pharma’s Pain Drug – OxyContin

May 08, 2007 -- COLUMBUS - Ohio and 25 other states, as well as the District of Columbia, filed settlements with Purdue Pharma Inc., regarding the narcotic pain medication OxyContin®. The settlement resolves concerns that Purdue had engaged in extensive off-label marketing of OxyContin®, a time-released, Schedule II opioid used for pain management of moderate to severe pain, and that Purdue failed to adequately disclose abuse and diversion risks associated with the drug in violation of the states’ respective consumer protection statutes.

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“It’s important that drug companies marketing painkiller drugs like OxyContin® take into consideration the safety risks involved with the drug,” Said Attorney General Marc Dann. “Failing to adequately account for possible abuse of the drug with off-label marketing, not only is it unsafe for Ohio consumers but also creates an unfair business market.”

The settlement for Ohio was filed in Franklin County Common Pleas Court. The injunctive provisions contained in the settlement address those marketing practices believed to have been excessive or abusive. Significantly, the settlement further requires Purdue to maintain an abuse and diversion-detection program 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 settlement, 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 payments for grants publicly disclose the existence of that payment;
* 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 on the volume of OxyContin® prescribed;
* take into account in the performance evaluations of sales representative’s 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 proposed settlement prohibits Purdue from making any false, misleading or deceptive claim regarding OxyContin®.

Finally, the settlement provides for a monetary payment by Purdue to the states in the amount of $19,500,000. Ohio’s share of the settlement is $949,500 which will be put in our Consumer Protection Fund and used for other consumer investigations.

States included in the investigation of Purdue’s business practices, as well as in today’s settlement were: Arizona, Arkansas, California, Connecticut, Idaho, Illinois, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Montana, Nebraska, Nevada, New Mexico, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Vermont, Virginia, Washington, Wisconsin and the District of Columbia.

Source: Ohio Attorney General