Arizona-based pharmaceutical company Insys Therapeutics Inc. (Insys) has found itself under investigation in both Massachusetts and New Jersey over the aggressive marketing of its opioid-fentanyl drug Subsys.
Subsys has been approved by the FDA for use with breakthrough pain in cancer patients who have developed tolerance to other opioid-based drugs. The drug makes up approximately 98 percent of Insys’ revenues.
Late last week New Jersey attorney general Christopher S. Perrino filed a civil lawsuit against Insys accusing it of devising an aggressive marketing plan in which the company pushed “off label” uses of the drug and, in Perrino’s words, “… putting lives in peril by pushing for broad-based consumption of a highly specialized and incredibly powerful prescription drug—a form of fentanyl approved only for treatment of pain-racked and opioid-tolerant cancer patients—Insys allegedly forged ahead anyway.” According to the New Jersey suit, the Insys marketing campaign advocated the use of the drug by physicians very distant from treating cancer patients, including podiatrists, and utilized various schemes to mislead health insurance plans and pharmacy benefit managers to secure coverage for the drug.
In a coincidence of timing, just as New Jersey began its pursuit of civil action against Insys, the company settled similar claims against it in the state of Massachusetts by agreeing to pay $500,000 to the state attorney general’s opioid addiction prevention, education, and treatment programs. As in the New Jersey lawsuit, Massachusetts argued that between 2012 and 2014 Insys promoted the use of Subsys as safe for people outside the approved group of cancer patients when such claims were not proven. Further, the state alleged that the company paid kickbacks to physicians who prescribed the drug to non-cancer patients and paid medical personnel to speak at “sham” conventions where the primary purpose was to convince the practitioners to prescribe Subsys.