SubSys Problems Result in Investigation Over Painkiller Marketing By Arizona AG

The Arizona Attorney General has launched an investigation into the sales tactics of InSys Therapeutics, the makers of the controversial fentanyl spray SubSys, which is a highly addictive and powerful pain medication that has been widely over-prescribed amid allegations of illegal marketing.

The investigation has not been confirmed by Arizona Attorney General Mark Brnovich, but was disclosed in an InSys filing with the Securities and Exchange Commission (SEC) last month.

The state joins the Federal Bureau of Investigations (FBI), as well as Colorado, Florida, Illinois, Massachusetts, Maryland, Minnesota, New Hampshire, New Jersey, New York, Oregon, Pennsylvania and Washington, in having issuing subpoenas to the company in regards to its sales and marketing campaigns for SubSys. InSys is headquartered in Chandler, Arizona.

The company has also indicated that a number of physicians who subscribed SubSys to patients have received subpoenas as well, amid allegations that InSys illegally bribed doctors to prescribe medication off-label.

The pharmaceutical company’s marketing practices have been under investigation since December 2013.

The Department of Health and Human Services Office of Inspector General (DHHS-OIG) began investigating Insys, the manufacturer of Subsys, for possible illegal off-label marketing of the drug, after it catapulted past the $100 million sales mark despite being introduced with limited approval for cancer patients suffering from severe pain.

Earlier this month, one former company manager, Elizabeth Gurrieri, pled guilty to wire fraud conspiracy in connection with the investigation. She is the second company employee to plead guilty to charges related to Subsys sales.

Since the beginning of the year, a number of Subsys lawsuits have been filed in a number of state courts, claiming that the company mislead patients and bribed doctors to increase sales of the drug.

Subsys is a spray form of fentanyl, which is a painkiller that is considered 100 times more powerful than heroin. If an individual overdoses on fentanyl, it can result in severe and life-threatening injuries.

The broad sales of Subsys raised suspicions, because the FDA approved the new drug in 2012, with recommendations that only oncologists and pain specialists prescribe the drug. Those doctors also had to undergo special training before being allowed to prescribe the drug, and patients have to sign an agreement that they understand the risks involved as part of a Subsys Risk Evaluation and Mitigation Strategy (REMS).

Following a 270% increase in sales over just a year, it appeared that only 1% Subsys sales are by oncologists, about half are from pain specialists, and the rest of the prescriptions are issued by doctors, dentists and even podiatrists who appear to be using the drug off-label.

While doctors are permitted to prescribe any approved medication for whatever purposes they see fit, it is illegal for pharmaceutical companies to promote their drugs for applications that have not been approved by the FDA after establishing that it is safe and effective for that use.

Claims against the company include personal injury and wrongful death lawsuits indicating that sales reps were specifically told to push doctors to sell the powerful painkiller to patients who were not fighting cancer because those patients could live longer and they could increase their dosage.

Insys has insisted that the actions are in the company’s past and that it is trying to improve its corporate culture, focus on patient safety, and that it has purged employees linked to questionable activities. However, it is expected that the number of Subsys lawsuits will continue to grow as more patients step forward and the state and FBI investigations continue.