Vermont Resolves Marketing Concerns Over OxyContin

Settlement with Vermont Will Reach almost $950,000

May 8, 2007 - Vermont and 25 other states, as well as the District of Columbia, filed Consent Judgments regarding the narcotic pain medication OxyContin. The settlement resolves concerns that Purdue Pharma, the manufacturer of OxyContin, had engaged in extensive off-label marketing of this time-released, Schedule II opioid. Pharmaceutical companies are generally not allowed to market their prescription drugs for uses that are not approved by the U.S. Food and Drug Administration. OxyContin is approved for pain management of moderate to severe pain over an extended period of time. Marketing the product for other uses is known as “off-label” marketing. The settlement also resolves concerns that Purdue failed to adequately disclose abuse and diversion risks associated with the drug. The State of Vermont will receive $950,000 as a result of today’s settlement.

“The safe prescribing and use of pharmaceuticals used by Vermonters depend upon honest marketing by pharmaceutical companies,” said William H. Sorrell, Attorney General. “Purdue Pharma breached the trust that we place in pharmaceutical companies by marketing this potentially dangerous product for uses not approved by the FDA, and without adequate oversight, all with potentially harmful results to patients as well as communities.”

The Consent Judgment, filed today in Washington County Superior Court, addresses Purdue Pharma’s marketing practices that General Sorrell believes to have been excessive and abusive. Significantly, the settlement requires Purdue to maintain an abuse and diversion-detection program to detect problem prescribing, and requires all sales representatives to undergo training on the program before being allowed to promote OxyContin.

Other restrictions contained in the Consent Judgment include requirements that Purdue Pharma must:

# not market or promote OxyContin for off-label purposes – those beyond the indications and uses of the drug approved by the FDA;
# market and promote OxyContin in a manner that does not minimize the approved uses for the drug;
# have any recipient of funds for continuing medical education programs and other forms of 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.

The Consent Judgment provides for a monetary payment by Purdue to the states in the amount of $19,500,000. Vermont’s share of the settlement is $949,500.

Taking part in the investigation of Purdue’s business practices, as well as in today’s settlement, are the following additional states: 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, Virginia, Washington, Wisconsin and the District of Columbia.

Source: Vermont Attorney General

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