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Illinois Attorney General Sues Drugmaker For "Deceptive Marketing" of Fentanyl-Based Painkiller
Illinois Attorney General Lisa Madigan has sued drugmaker Insys Therapeutics Inc., charging the company with “deceptively marketing and selling” its fentanyl-based medication, Subsys, to doctors for off-label uses. Insys is under investigation for numerous infractions involving Subsys, the state announced.
Drug companies are not allowed to market their drugs for “off-label” uses – meaning any purpose other than what was approved by the Food and Drug Administration (FDA).
Although doctors can decide to use drugs off-label, drug companies can’t recommend any uses beyond the FDA approved use, and that means to anyone – doctors, patients or the public.
The fentanyl painkiller Subsys, which reached the marketplace in 2012, was approved by the FDA only for managing serious cancer pain. Fentanyl is a highly-addictive synthetic opioid that is 50 to 100 times more powerful than morphine. Subsys generated $329.5 million net revenue for Insys in 2015.
The Illinois suit claims that instead of marketing the drug only for treating cancer patients, the company illegally promoted it to doctors “who prescribed high volumes of opioid drugs.”
“This drug company’s desire for increased profits led it to disregard patients’ health and push addictive opioids for non-FDA approved purposes,” Madigan said in a statement.
Madigan explained that Insys “rewarded” doctors nationally for prescribing Subsys for off-label uses by offering payments for “sham speaking events and expensive restaurant dinners.”
News service Reuters reports that the Illinois case was brought after federal prosecutors in New York City had already charged two former Insys employees for “engaging in a scheme to pay doctors kickbacks including speaker fees to prescribe Subsys” for unapproved uses. The ex-employees, a former Insys district sales manager and a former sales rep, pleaded not guilty to the charges.
Insys only the latest in a long succession
Over the past 15 years, nearly two dozen drug companies have run afoul of off-label promotion and marketing restrictions and for various other infractions. They’ve been fined by federal and state agencies, some being the largest corporate fines in American history.
If Insys loses its case in Illinois and is fined, it will only be the latest in a long succession of drug companies so charged. Most were fined for off-label promotion and marketing and usually for also paying kickbacks to doctors. A few were fined for failing to disclose product safety information, and others for Medicare and Medicaid fraud. Several have been fined for a combination of these.
Fines have ranged from a low of $345 million up to more than a billion dollars, and the fines have been trending higher. In fact, in the past 6 or 7 years, there have been at least five companies found guilty of off-label promotion whose fines exceeded a billion: GlaxoSmithKline (GSK) for $3 billion, Pfizer for $2.3 billion, Johnson & Johnson for $2.2 billion, Abbott Labs for $1.5 billion and Eli Lilly for $1.4 billion. GSK’s fines included $1 billion for criminal charges, and $2 billion civil penalties. The others were also civil penalties.
Just a cost of doing business?
The watchdog group Public Citizen claims that such fines have become merely a “cost of doing business” at pharmaceutical companies. And over the last couple of years, the amounts of fines and penalties have sharply declined. The group recently released a report that analyzed 25 years of drug company settlements.
Sammy Almashat, one of the Public Citizen researchers, said he doesn’t believe that the recent decreases mean that pharmaceutical companies are in more compliance with regulations.
“Previous penalties never have been large enough to deter the most common types of pharmaceutical fraud,” he said. “So it would be surprising if the industry suddenly decided of its own accord to comply with laws it has routinely violated for decades.”
Until fines are significantly increased and jail terms are meted out for executives who order or condone such practices, official reprisals have little or no impact on corporate behavior.
Opioids – especially fentanyl – are today’s big problem
In today’s heated climate of opioid addiction and overdose deaths, the Insys case is attracting more official attention than usual. And because it concerns fentanyl, a synthetic opioid that is devastating the overdose landscape from coast to coast, Insys is really under the gun.
As well as imposing financial penalties on the company, Madigan’s office is raising the bar by seeking to ban the company from selling any of its products in the state of Illinois. The AG’s office is also investigating other opioid manufacturers for similar practices.
Losing an entire state from its market is a serious threat to any pharmaceutical company. And other states are eyeing the Illinois Insys case very carefully.
Fentanyl has been showing up as a deadly additive in heroin and fake opioid painkiller pills and potions. The results have been a violent spike in overdose deaths over the past 18 months, and it’s getting worse.
Any activity that would tend to increase fentanyl abuse – such as encouraging doctors to more widely prescribe fentanyl for conditions other than its FDA-approved cancer pain is looked on with extreme disapproval by law enforcement and the broader medical community.
Here at Novus we help patients with opioid dependence get drug-free and get their lives back. And we’re thankful for all official policies and programs that help reduce the opioid epidemic by any effective means.
If you or someone you care for has a problem with opioid painkillers or illicit opioids like heroin or street-level fentanyl, don’t hesitate to call Novus.
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