AG Healey: Drug Manufacturer Illegally Marketed Fentanyl; Paid, Disguised Kickbacks

BOSTON – An opioid manufacturer will pay $500,000 to resolve allegations that it engaged in a widespread scheme to unlawfully market its fentanyl spray and paid kickbacks to providers to persuade them to prescribe the product, Attorney General Maura Healey announced today.

The consent judgment entered today in Suffolk Superior Court resolves allegations that Insys Therapeutics, Inc. misleadingly marketed Subsys, a narcotic fentanyl product that is sprayed under a patient’s tongue. Fentanyl, a synthetic opioid, is estimated to be 50 to 100 times more potent than morphine and 30 to 50 times more powerful than heroin.

“Fentanyl is a powerful and highly addictive drug with deadly consequences, yet this opioid maker aggressively marketed its product and made illegal payments to providers to boost sales,” said AG Healey. “Drug companies cannot endanger the health and safety of patients to increase their own profits.”

The AG’s Office began an investigation into Insys’ marketing of Subsys in 2014.

The investigation revealed that between 2012 and 2014, Insys marketed the product for use in treating pain in non-cancer patients, even though there is no evidence that Subsys is safe and effective for such use and the FDA had approved the product only for use in cancer patients. The company also made misleading statements that Subsys was appropriate to treat “mild” pain, including citing a study that specifically states that it is only appropriate for “moderate to severe” breakthrough pain in cancer patients.

Insys’ compensation system also incentivized its sales representatives to aggressively market Subsys for any and all potential uses regardless of the safety or efficacy of such use.

The AG’s investigation revealed that the company paid kickbacks to clinicians to induce them to prescribe Subsys and disguised the kickbacks as fees paid to speak to other health care providers about the product.

The settlement money will help fund the AG’s prevention, education and treatment efforts. In addition to the payment to the AG’s Office, the settlement requires Insys to ensure that its marketing and promotional practices do not unlawfully promote Subsys and that its employees do not pay kickbacks to physicians or other prescribers.

This matter was handled by Assistant Attorney General Eric Gold, Chief of AG Healey’s Health Care Division and Assistant Attorney General Michael Wong, also of the AG’s Health Care Division.