Risk & Compliance

Insys to Pay $225M to Settle Painkiller Probes

The maker of the fentanyl spray Subsys "is being held responsible for its role in fueling the opioid epidemic," a prosecutor says.
Matthew HellerJune 10, 2019

Opioid maker Insys Therapeutics has agreed to pay $225 million to settle allegations that it paid kickbacks to doctors and nurse practitiioners to induce them to prescribe its flagship fentanyl painkiller.

As part of the deal, Insys will plead guilty to five criminal counts of mail fraud and pay a $2 million fine and $28 million in forfeiture. It will also pay $195 million to settle several whisteblower lawsuits accusing it of violating the False Claims Act.

The settlements came a month after a jury found Insys founder John Kapoor and four other former executives and managers guilty of bribing doctors and misleading insurance companies.

“For years, Insys engaged in prolonged, illegal conduct that prioritized its profits over the health of thousands of patients who relied on it,” Andrew E. Lelling, the U.S. attorney for the District of Massachusetts, said in a news release. “Today, the company is being held responsible for that and for its role in fueling the opioid epidemic.”

The federal government and a large number of states have been seeking to hold drug makers accountable for the nation’s opioid epidemic, which has led to more than 200,000 overdoses in the past two decades.

The Insys case is one of the few criminal prosecutions to date in which a corporation has been accused of opioid-related wrongdoing.

The company’s fentanyl product, Subsys, is an under-the-tongue spray that the Food and Drug Administration approved in 2012 only for treating pain in cancer patients. But according to the government, it quickly began marketing the drug to a broader range of patients, using lavish dinners and other events to entice doctors to prescribe more of it.

Prosecutors said Insys used sham “speaker programs” as a vehicle to pay bribes and kickbacks to practitioners in exchange for prescribing Subsys and increasing the dosage of prescriptions.

One physician’s assistant who joined the propgram allegedly wrote approximately 672 Subsys prescriptions for his patients — many of which were medically unnecessary — and in turn, received $44,000 in kickbacks from Insys.

In May, Insys disclosed that its legal costs might force it into bankruptcy.

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