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Attorney General sues opioid manufacturer, alleges fraud and kickbacks

N.C. Attorney General Josh Stein at a September press conference on the opioid epidemic.

Attorney General Josh Stein announced Thursday [1] his office is filing suit against Insys Therapeutics, Inc., manufacturer of Subsys, a synthetic opioid spray.

The drug is about 50 times more powerful than heroin and 100 times more than morphine. The lawsuit alleges the company used kickbacks, fraud and deceptive marketing to push doctors to prescribe the highly addictive drug to patients for which it wasn’t approved.

The drug, approved for cancer patients experiencing pain that other drugs can’t address, has been much more widely prescribed. Over-prescription of such drugs has greatly contributed to the ongoing opioid epidemic.

“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,” Stein said in a statement Thursday. “This is unconscionable, it’s unacceptable and it’s illegal. Today, I am acting to hold them accountable.”

From the statement:

The lawsuit alleges that Insys gave illegal kickbacks to doctors for promoting and prescribing Subsys for non-cancer patients, including through a multi-million dollar speaker program that rewarded physicians who wrote prescriptions for the drug. 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.]” This speaker program included an Insys-sponsored presentation at a headache clinic in Chapel Hill, during which a speaker pushed Subsys to headache specialists.

Insys employees also pushed doctors to switch patients who were being prescribed non-equivalent fentanyl prescriptions to Subsys, and often at a starting dose of up to twelve or sixteen times larger than the label directed.

Finally, the suit alleges that Insys deceived health insurers into covering Subsys prescriptions. Insys employees often posed as prescribers or their staff and invented medical histories for patients to ensure the drug would be covered. Only about 10 percent of prescriptions for which Insys sought prior authorization from insurers were for patients with breakthrough cancer pain, the only use the FDA had approved.

Approximately 1,600 North Carolinians – nearly four a day – died of drug overdoses last year.  It is the number one cause of accidental death in the state. According to the latest data, one in 100 newborns in the state begin life with opioid dependency.

Back in September, Stein announced an expanded investigation [2] into the ongoing epidemic and called for more funding to battle it.

When lawmakers approved the final state budget [3] in June, many expected the bipartisan concern would lead to significant funding to combat the opiate problem.

But while the budget did improve funding for the state’s Controlled Substances Reporting System [4] and funneled $10 million in federal grants to treatment services, it was well under what Gov. Roy Cooper called for in his suggested budget  [5]and only about half of what was called for in the bipartisan Strengthen Opioid Misuse Prevention (STOP) Act [6].

State health experts have repeatedly said expanding Medicaid under the Affordable Care Act would go a long way toward that goal, Cohen said – but that’s something the GOP majority in the legislature have also refused to do [7].