May 30, 2018 07:16 PM
Minnesota's attorney general Wednesday announced a lawsuit against an Arizona-based opioid manufacturer for illegally marketing a fentanyl painkiller for unapproved conditions and at higher doses than approved by the FDA.
According to a release from Attorney General Lori Swanson's office, the lawsuit alleges Insys Therapeutics marketed Subsys, a rapidly-absorbed fentanyl spray, to patients who did not have cancer. The FDA in 2012 approved Insys to market the painkiller "only for the management of breakthrough pain in cancer patients whose existing long-acting opioids did not adequately control their pain."
The FDA also said Subsys "was only to be used by oncologists and pain specialists skilled in cancer pain treatment," according to the release.
"To enrich its balance sheet, the company encouraged physicians to prescribe this highly-potent fentanyl product to patients who didn't have cancer, even though it was only approved for severe breakthrough pain in cancer patients," Swanson said.
The lawsuit alleges Insys established quotas for its sales force of one or more new Subsys prescriptions per day. To increase sales, Insys allegedly promoted Subsys for off-label uses and at higher doses and sought out doctors who would be willing to susbcribe the drug to non-cancer patients.
The FDA-approved label for Subsys stated all patients must start at the lowest dose of 100 micrograms. Swanson's lawsuit alleges the company had incentives for sales agents to get physicians to increase prescribed doses.
Materials Subsys provided to physicians said "75% of patients found an effective SUBSYS does between 600 and 1600 [micrograms]," and "only 4% of patients reported 100 [micrograms] as an effective dose," according to the release. The sales force at Insys was paid $340 per quarter for each 100 microgram prescription, but $2,532 per quarter for 1,200 microgram prescriptions, the lawsuit states.
According to the lawsuit, a sales manager told Insys' vice president a Minnesota doctor was "scared to prescribe" the painkiller and did "not want a reason for the DEA to come after him."
The vice president responded, "Stop with the excuses and start with solutions," the lawsuit alleges.
According to the release, Insys paid two Minnesota physicians more than $43,000 for speaking events and these physicians later became the company's top subscribers in Minnesota. The lawsuit alleges some of these events were fronts, attended only by a sales agent or the physician's office staff, and that the payments were used to incentivize physicians to prescribe Subsys.
Several Insys executives, including the former vice president of sales and former CEO, were indicted by the U.S. attorney in Masachusetts for the role in marketing Subsys, according to the release.
The release also states the Minnesota Board of Medical Practice entered a stipulation with a physician assistant for prescribing excessive doses of Subsys. Insys sales agents visited that assistant 16 times, during which she wrote 52 Subsys prescriptions, according to the release.
"By promoting the off-label use of a powerful opioid and by making inappropriate payments to prescribers, Insys has broken the law and jeopardized the public health. It is imperative that medications are prescribed appropriately," Minnesota Board of Pharmacy Executive Director Cody Wiberg said. "Consequently, it is important to make sure that Insys is held accountable for its actions."
Fentanyl is a synthetic opioid 50 times more powerful than heroin. In 2017, fentanyl was a contributing factor in the deaths of 156 people in Minnesota.
Updated: May 30, 2018 07:16 PM
Created: May 30, 2018 11:43 AM
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