Regulatory Focus™ > News Articles > Illinois Attorney General Sues Fentanyl Drugmaker for Deceptive Off-Label Marketing

Illinois Attorney General Sues Fentanyl Drugmaker for Deceptive Off-Label Marketing

Posted 25 August 2016 | By Zachary Brennan 

Illinois Attorney General Sues Fentanyl Drugmaker for Deceptive Off-Label Marketing

Illinois Attorney General Lisa Madigan on Thursday filed a lawsuit against Insys Therapeutics for deceptively marketing and selling its opioid Subsys (fentanyl), approved exclusively for the treatment of cancer pain, to physicians treating non-cancer patients for off-label uses like back and neck pain.

Madigan alleges that Insys illegally marketed its painkiller to doctors who prescribed high volumes of opioid drugs instead of focusing its marketing on oncologists.

And as FDA notes in its summary review of approval of Subsys, the off-label marketing of such opioids is part of a wider trend for these transmucosal immediate-release fentanyl (TIRF) products.

Subsys was the sixth new drug application approved by FDA for a TIRF product indicated for the management of breakthrough pain in patients with cancer, 18 years of age and older, who are already receiving and who are tolerant to regular opioid therapy for underlying persistent cancer pain.

A Risk Minimization Action Plan (RiskMAP) was created by FDA to attempt to manage the risks associated with this product.

“In addition to providing some methods to try and minimize the risk for accidental pediatric exposure, other goals described in the RiskMAP included preventing use in opioid non-tolerant patients and other unsafe off-label use,” FDA explains, noting a postmarketing history that reveals prescribers have found the TIRFs “to be useful in patients without cancer pain, both in the setting of chronic pain with episodes of breakthrough pain and other painful,” noting that for one TIRF called Actiq (fentanyl citrate), its use for noncancer pain has exceeded its use in cancer pain.  

“This drug company’s desire for increased profits led it to disregard patients’ health and push addictive opioids for non-FDA approved purposes,” Madigan said in a statement.

Her lawsuit stems from an investigation into allegations that Insys was marketing Subsys broadly as a treatment for breakthrough pain associated with chronic conditions, including back and neck pain, despite the lack of FDA approval for those uses. Insys also pushed doctors to prescribe the higher and more expensive doses of Subsys, contrary to FDA mandates aimed at keeping patients on the lowest effective dose.

The investigation also found that doctors were rewarded for prescribing Subsys to non-cancer patients for off-label uses, including payments for sham speaking events and dinners at expensive restaurants.

In Illinois, the top Subsys prescriber was Dr. Paul Madison, who wrote approximately 58% of the Subsys prescriptions in the state, though more than 95% of the Subsys prescriptions written by Dr. Madison did not relate to breakthrough cancer pain, the lawsuit alleges. Madison was also indicted by the US Attorney’s Office in Chicago for billing insurers for procedures he did not perform.

Madigan’s lawsuit against Insys seeks to permanently bar the company from selling its products in Illinois and impose financial penalties for violating the Consumer Fraud Act.


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