Oregon Attorney General Ellen Rosenblum today reached a $1.1 million settlement with Insys, the company that manufactures the schedule II opioid drug Subsys, to resolve allegations that the powerful drug approved by the Food and Drug Administration (FDA) to treat cancer pain was marketed in Oregon for off-label uses such as non-cancer neck and back pain. The Assurance of Voluntary Compliance (AVC) also resolves allegations that the company provided improper financial incentives to some doctors to increase Subsys prescriptions, targeted doctors for aggressive promotion of Subsys when the doctor was not qualified to prescribe the drug, and deceptively promoted Subsys for treatment of mild pain. Oregon is the first government entity to settle with Insys for this alleged misconduct.
“Subsys is a very powerful narcotic that has been approved for only a very specific and narrow use,” said Attorney General Rosenblum. “Schedule II drugs have a very high potential for abuse and addiction, and it is unconscionable that a company would promote such a powerful drug for off-label uses as well as misrepresent to doctors the benefits of the drug.”
Under the AVC filed in Multnomah County Circuit Court, the company may not make any false or misleading claims when marketing Subsys in Oregon and must comply with all laws relating to the marketing and promotion of prescription drugs, including federal anti-kickback laws. The company may also not market Subsys in Oregon as a treatment for mild cancer pain, or mild pain of any kind, unless the FDA expressly approves the promotional claim.
The settlement requires Insys to pay $533,000 to the state of Oregon. An additional $567,000 will be paid to a non-profit or governmental organization identified by the Oregon Attorney General to help prevent opioid abuse and misuse in the state. Total Oregon Subsys sales for the time period of the investigation were $511,000.
In addition to the Insys settlement, Attorney General Rosenblum also announces a $2.1 million grant to the National Association of Attorneys General to help combat the misuse and abuse of opioids. The grant, which will be administered by the Oregon Department of Justice, comes from the $28 million Neurontin Settlement Grant program created from the 2004 Neurontin multi-state settlement that was led by the Oregon Department of Justice.
Rosenblum commended the work of Assistant Attorney General David Hart and his investigative team at the Oregon Department of Justice.
Kristina Edmunson, Department of Justice, Kristina.Edmunson@doj.state.or.us, 503-378-6002