Dive Brief:
- North Carolina has joined the basket of states suing manufacturers over its practices and the impact on the opioid epidemic.
- North Carolina Attorney General Josh Stein filed a lawsuit against Insys Therapeutics, Inc., which includes allegations of kickbacks, deception and fraud over sales of Subsys, the company's sublingual fentanyl spray.
- According to Stein, Insys gave illegal kickbacks to physicians for prescribing the spray to non-cancer patients, pushed physicians to switch non-Subsys patients to their drug, often at much higher doses; and deceived health insurers. Insys had no comment.
Dive Insight:
Accusations against Insys in the North Carolina case have suggested falsifying claims to insurers, promoting off-label use, and deceptive marketing. The case cites a multi-million dollar speaker program that rewarded high prescribers. According to a statement from the North Carolina Department of Justice, in 2012, a Charlotte-based vice president of sales told one sales rep, “They do not need to be good speakers, they need to write a lot of [Subsys prescriptions.]”
Insys had no comment when contacted by BioPharma Dive.
Subsys is approved only for use in adult cancer patients with breakthrough pain and who are tolerant to opioids. North Carolina pain specialist Christopher Grubb noted its quick absorption into the system makes the drug highly addictive, speaking in a press conference on the matter Thursday, according to local reports.
"As millions of Americans were becoming addicted to and dying from prescription painkillers, it appears Insys and its sales representatives pushing its incredibly potent opioid on North Carolina patients just to make more money," said Attorney General Stein in a release. "This is unconscionable, it’s unacceptable and it’s illegal. Today, I am acting to hold them accountable."
It's just the latest challenge that Insys has faced this year. In early October, New Jersey filed charges against the company alleging at least one death linked with the sublingual fentanyl spray Subsys, and as much as $10.3 million paid out in reimbursement to cover off label use of Subsys. In August, Insys paid $4.45 million to the state of Illinois to settle charges from a 2016 lawsuit.
And at the end of October this year, Insys founder and majority owner John N. Kapoor stepped down after his arrest on charges alleging conspiracy to push prescriptions of fentanyl spray.