Antitrust Law Daily Wrap Up, ADVERTISING NEWS: Illinois AG sues drug maker Insys over deceptive marketing of opioid painkiller Subsys, (Aug 26, 2016)

By Linda O’Brien, J.D., LL.M.

Pharmaceutical company Insys Therapeutics deceptively marketed and sold Subsys—a highly addictive opioid painkiller intended exclusively for treatment of breakthrough cancer pain—to physicians who treated non-cancer patients for off-label uses such as back and neck pain, according to a complaint filed by Illinois Attorney General Lisa Madigan in the Cook County Circuit Court in Chicago (State of Illinois v. Insys Therapeutics, Inc., August 25, 2016).

Specialty pharmaceutical company Insys Therapeutics manufacturers Subsys, a prescription opioid drug consisting of the powerful and highly addictive narcotic fentanyl, which is administered through a sub-lingual (under the tongue) spray.

According to the Attorney General’s complaint, in January 2012, the Food and Drug Administration (FDA) approved Subsys for the management of pain in cancer patients who are 18 years of age and older and are already receiving and tolerant to opioid therapy for their underlying persistent cancer pain. To reduce the risk of misuse of opioids, the FDA instituted a Risk Evaluation and Mitigation Strategy ("REMS") for Subsys in which prescribers must enroll in the REMS program before writing a prescription for Subsys.

The "Indications and Usage" section of Subsys’s label states that the drug is intended to be used only in the care of cancer patients and only by oncologists and pain specialists who are skilled in the use of Schedule II opioid to treat breakthrough cancer pain. The complaint claims that, instead of focusing on oncologists and pain specialists who treat cancer pain, Insys directed its promotion and marketing in Illinois to high-volume opioid prescribers who were not oncologists or cancer pain specialists. An investigation by the Attorney General revealed that Insys identified prescribers into deciles according to the number of rapid onset opioids (ROOs) that he or she prescribed. Sales representatives were purportedly instructed to call on high-volume prescribers more frequently than low-volume prescribers.

Additionally, the complaint charges, sales representatives were encouraged to secure the majority of their sales from one or two high-volume prescribers. From April 2012 until March 2015, Insys sold almost $12 million of Subsys in Illinois. Approximately 94 percent of those sales were attributable to Illinois’ top ten Subsys prescribers, with the highest volume Subsys prescribers being Dr. Paul Madison. Over 95 percent of the Subsys prescriptions written by Dr. Madison were for patients who did not have cancer and related to back, neck, or other types of chronic pain.

Opioid drug use is a growing public health epidemic in the United States and approximately 78 American die every day from an opioid drug overdose. According to the Attorney General’s investigation, an Illinois Insys sales representative expressed concerns to the sales supervisor after observing patients in Dr. Madison’s office who exhibited drug seeking attributes and behavior. The sales supervisor purportedly responded to encourage the sales representative to still call on Dr. Madison frequently. Although Insys knew that Dr. Madison did not routinely treat cancer patients and was possibly running a "pill mill," the sales representatives continued to market Subsys to Dr. Madison and even paid him to promote Subsys at 46 speaking events in Illinois. Dr. Madison was indicted on federal false billing claims charges in December 2012, the complaint stated.

The complaint also claims that Insys aggressively marketed Subsys to Illinois prescribers who saw few, if any, cancer patients. This marketing included having Illinois sales representatives: (1) target patients taking competing prescription opioid drugs regardless of whether the patient had breakthrough cancer pain; (2) contact patients directly and assist with completing insurance prior authorization forms; and (3) represent the effective dose to mean a high dose of Subsys.

"This drug company’s desire for increased profits led it to disregard patients’ health and push addictive opioids for non-FDA approved purposes," said Attorney General Madigan in a press release. "It’s this type of reprehensible and illegal conduct that feeds the dangerous opioid epidemic and is another low for the pharmaceutical industry."

The Attorney General’s complaint asserts claims for unfair and deceptive practices in violation of the Illinois Consumer Fraud and Deceptive Business Practices Act. The action seeks injunctive relief, as well as civil penalties, costs of suit, and any other just and proper relief.

The case is No. 2016CH11216.

Attorneys: Lisa Madigan, Attorney General of Illinois, and Susan Ellis, Consumer Fraud Bureau, for the State of Illinois.

Companies: Insys Therapeutics, Inc.

News: Advertising ConsumerProtection IllinoisNews