Wednesday, May 30, 2018
Attorney General Swanson and Pharmacy Board Sue Opioid Manufacturer Over Aggressive Marketing of Highly-Addictive Painkiller
Attorney General Lori Swanson and the Minnesota Board of Pharmacy today filed a lawsuit against Insys Therapeutics, Inc., based in Arizona, for illegally marketing a fentanyl painkiller—approved by the federal Food and Drug Administration only to treat breakthrough pain in cancer patients—for other unapproved conditions and at doses many times higher than approved by the FDA.
“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,” said Attorney General Swanson. She added: “The company paid non-oncologists money to incentivize them to prescribe this drug. It called the payments ‘speaker fees’ to skirt a Minnesota law that prohibits pharmaceutical companies from paying gifts to doctors, even though the company was unable to provide evidence that some of the supposed ‘speeches’ had any audience other than the sales agent or physician’s office staff.”
“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. Consequently, it is important to make sure that Insys is held accountable for its actions,” said Cody Wiberg, Executive Director of the Minnesota Board of Pharmacy.
Fentanyl is an opioid painkiller that is up to 100 times stronger than morphine. The FDA approved Insys to market Subsys (a rapidly-absorbed fentanyl spray) in 2012 only for the management of breakthrough pain in cancer patients whose existing long-acting opioids did not adequately control their pain. The FDA cautioned that Subsys was only to be used by oncologists and pain specialists skilled in cancer pain treatment. The label approved by FDA in 2012 further stated that all patients must be started at the lowest dose of 100 micrograms.
Quotas. Insys established quotas for its sales force of one or more new Subsys prescriptions per day. Company executives told a Minnesota sales manager to “make sure each of your reps has at least one doctor they can count on for a daily prescription.” (¶44.) The sales manager in turn admonished a Minnesota saleswoman that “[i]f you can not average 1.7 Rx’s per day you can not do this job.” (¶45.)
Unapproved Uses. While doctors may prescribe a drug for unapproved or “off-label” uses, manufacturers are prohibited by federal law from promoting the drug for such unapproved uses. The lawsuit alleges that Insys promoted Subsys for off-label uses and at doses contrary to FDA-approved limits. The lawsuit also alleges that the company sought to increase sales by expanding the use of its product beyond cancer patients by identifying family practice and internal medicine doctors and anesthesiologists to prescribe the product. For example, over 96% of Subsys prescriptions nationwide were written by non-oncologists during one quarter, according to company records. (¶59.)
When a Minnesota sales manager and agent explained to Insys’s vice president of sales that a Minnesota physician was “scared to prescribe” Subsys 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[.]” (¶53.)
Insys encouraged its sales agents to spend their time marketing to one or two high-volume physicians who would prescribe Subsys to non-cancer patients. The company’s former vice president of sales told sales managers that “The reps need to find 1 or 2 doctors to live with,” calling these doctors “the ‘golden gem’ physicians.” (¶66.) A regional sales manager for Minnesota told her sales team: “[f]ind your 1 to 2 docs and move in.” (¶70.) It called signing up a patient on Subsys “an annuity that keeps paying.” (¶88.)
Insys prepared materials to describe Subsys to physicians. These materials said that Subsys could be used for “mild” breakthrough cancer pain, even though the article it cited for this defined breakthrough cancer pain as “severe or excruciating”. (¶72-73.)
Unapproved doses. The company incentivized its sales agents to get physicians to increase the doses prescribed to patients. The FDA states that prescribers should always start patients at 100 micrograms and use the lowest possible effective dose. (¶78, 80.) The company distributed materials to Minnesota physicians stating that “75% of patients found an effective SUBSYS dose between 600 and 1600 mcg” and that “[o]nly 4% of patients reported 100 mcg as an effective dose.” Insys offered its sales force extra bonuses for higher doses, paying them $340 per quarter for 100 microgram prescriptions but $2,352 per quarter for 1,200 microgram prescriptions. (¶88.)
Over 80 percent of initial prescriptions by Minnesota physicians were above the FDA-approved 100 mcg initial dose. (¶95.)
The company also gave cash incentives of up to $3,000 for sales agents who got the most prescriptions from doctors who previously prescribed a competitor’s product, calling such doctors “low hanging fruit ready for the picking.” (¶103-104.)
Speaker Fees. Minnesota law prohibits pharmaceutical manufacturers from paying gifts to health care practitioners of more than $50 per year. There is an exemption for reasonable honoraria and expense of a “practitioner who serves on the faculty at a professional or educational conference or meeting.” (¶171.) Insys ran a “Speaker Program” that paid over $43,000 to two Minnesota physicians for 36 Speaker Program events. These physicians became the company’s top prescribers in Minnesota.
The lawsuit alleges that these payments violated Minnesota’s gift ban statute because they were not “reasonable honoraria” for bona-fide faculty members and instead were payments to incentivize the physicians to prescribe Subsys. Insys was unable to provide evidence that some of the supposed “speeches” had any audience other than the sales agent or physician’s office staff. (¶141.)
At the time Insys included the two Minnesota physicians in its Speaker Program, neither had written a prescription for Subsys, but both consistently began writing Subsys prescriptions within weeks of joining the Speaker Program. (¶148.) After one such Speaker Program event, a Minnesota sales manager admonished a sales agent that: “After today’s [Speaker Program], you will sit in [Physician’s] office and OPT IN FIVE PATIENTS….[Physician] MUST prescribe for FIVE patients TODAY.” (¶ 160.) Insys sales agents visited the two physicians hundreds of times. The same sales manager wrote to its Minnesota sales agent, “happy to hear that you’ve moved in with [physician.] Awesome!” (¶130.) Insys’s sales manager told a sales agent that she needed to “make a point to be present in [these physicians’] offices every day.” (¶ 159.)
In 2012, Subsys was the sixth trans-mucosal immediate-release fentanyl product approved by the FDA for breakthrough pain in cancer patients already taking opioids. (¶25.) By 2016, Subsys had 42 percent of this market, making it the most prescribed product in its class. (¶64.)
Several company executives, including its former vice president of sales and former CEO, were indicted by the United States Attorney in Massachusetts for their role in marketing Subsys. (¶50.) Last year, the Minnesota Board of Medical Practice entered a stipulation with a physician assistant for prescribing Subsys at doses that exceeded the recommended initial dose without medical justification. (¶49.) Insys sales agents visited her 16 times, during which she wrote 52 Subsys prescriptions.
The lawsuit was filed in Hennepin County District Court and seeks injunctive relief. It alleges violations of the state consumer fraud and deceptive trade practices laws and the pharmaceutical gift ban statute. An action was also brought by the Minnesota Board of Pharmacy before the Office of Administrative Hearings seeking civil penalties and other appropriate relief against Insys, which is licensed as a manufacturer and wholesale distributor under Minnesota state law.