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New York State Attorney General Eric Schneiderman became the latest attorney general to sue Insys Therapeutics Inc. for allegedly misrepresenting that a spray version of the opioid fentanyl is safe for non-cancer patients and appropriate for mild pain.
A.G. Schneiderman Sues Fentanyl Maker Insys Therapeutics, Inc. For Dangerous And Deceptive Promotion Of Prescription Opioid Subsys
Complaint Alleges that Insys Deceptively Promoted Subsys In New York For Unsafe Uses, Violated State Law By Downplaying Drug’s Addictive Risks
In Addition To Penalties, Suit Seeks To Disgorge Insys’ Illegally Earned Revenue—Up To $75 Million
Suit Marks Latest Action In AG Schneiderman’s Multi-Pronged Strategy To Tackle The Opioid Epidemic
NEW YORK – Attorney General Eric T. Schneiderman today announced that his office has filed a lawsuit against Insys Therapeutics, Inc., a company that sells a highly addictive fentanyl drug called Subsys. Although Subsys was approved by the Food and Drug Administration (FDA) to treat excruciating cancer-related breakthrough pain, the complaint alleges that Insys recklessly marketed the drug for much wider use, covering a much broader set of patients. Additionally, the company allegedly engaged in a pattern of deceptive and illegal conduct by downplaying the drug’s risks of addiction, bribing doctors to prescribe the drug, and lying to healthcare providers to skirt their authorization process. As a result, the Attorney General’s office is seeking penalties and disgorgement of all revenues accumulated during the period of misconduct—up to $75 million.
“At a time when the opioid epidemic was ravaging New York, Insys Therapeutics allegedly marketed a drug illegally by blatantly disregarding the grave risks of addiction and death that opioids pose,” said Attorney General Schneiderman. “As we allege, Insys showed a wanton disregard for the law and the lives of New Yorkers and we will hold them accountable. My office will continue to fight the opioid crisis at every level and hold corporations that prioritize profits above New Yorkers’ health and wellbeing to account.”
In late 2012, the FDA approved Subsys for the specific, limited treatment of breakthrough cancer pain in opioid-tolerant patients. Its purpose was to provide relief to cancer patients who were suffering from excruciating pain. Beginning in 2012, Insys allegedly ignored this limited approval and instead broadly targeted many types of providers and patients, and represented that the drug was appropriate for flares of mild pain. Insys also downplayed Subsys’ risk of addictiveness. The company further directed its sales representatives to urge providers to prescribe Subsys in high doses, which were more expensive than lower doses. A 30-unit prescription of the lowest strength medicine costs approximately $700, while a prescription for the highest strength costs over $3500.
Additionally, the complaint alleges that Insys sales representatives called on medical offices that employed providers who had been arrested for illegal opioid distribution.
In furtherance of their deceptive and illegal scheme, Insys allegedly formed a business unit devoted solely to securing prior authorization from health plans for as many patients as possible. Insys trained its prior authorization staff to imply that patients had cancer pain, even when they did not. Additionally, Insys allegedly bribed prescribers to write prescriptions for Subsys. The company paid certain providers between $3000 and $5000 to act as “speakers,” at sham promotional events and implored its sales staff to obtain a “return on investment” on those payments by increasing prescription numbers.
The lawsuit announced today is the most recent action the Attorney General’s office has taken to combat the opioid crisis. Attorney General Schneiderman’s multi-levered strategy to tackle New York’s evolving opioid epidemic includes:
- Obtaining settlements with major national and global health insurers including Cigna and Anthem, which insure over 4 million New Yorkers, to remove barriers to life-saving treatment for opioid use disorder. The agreements put an end to the insurers’ policy of requiring prior authorization for medication-assisted treatment (“MAT”), which can lead to significant delays for patients seeking relief from addiction.
- Creating the Internet System for Tracking Over-Prescribing Act (“I-STOP),a series of enhancements to New York’s prescription drug monitoring program that provide doctors with patient’s up-to-date controlled substance prescription history and established a safe disposal program providing a place for New Yorkers to get rid of expired and unneeded drugs—thus reducing the likelihood of stolen and forged prescriptions being used to obtain controlled substances from pharmacies. I-STOP reduced “doctor shopping,” a practice in which an individual attempts to obtain the same or similar prescriptions from multiple physicians, by 90% since 2014.
- Launching the Community Overdose Prevention (“COP”) program, a life-saving initiative that enabled state and local law-enforcement officers in the state of New York to carry naloxone, the extremely effective heroin antidote that can immediately reverse the effects of an opioid overdose. Since the program’s implementation in April 2014, more than 100 overdoses were reversed using kits provided by the COP program, which distributed over 27,000 kits across the state.
- Obtaining an agreement with Amphastar Pharmaceuticals, Inc. to cut and cap the price of naloxone for all agencies in New York State, reducing the price of naloxone by nearly 20 percent.
- Enforcing Mental Health Parity Laws to reach agreements with six health insurance companies, requiring them to implement sweeping reforms in their administration of behavioral health benefits, in particular relating to medical management practices, coverage of residential treatment for substance abuse, and co-pays for outpatient treatment, and to submit regular compliance reports. The agreements ultimately provided millions of dollars in penalties and over $2 million in restitution for members whose claims for were improperly denied.
- Successfully prosecuting more than ten licensed prescribers including operators of “pill mills” and other unlawful practices for crimes related to improper opioid prescriptions.
- Cracking down on drug trafficking networks that traffic opioids into communities around the state. The Attorney General’s Organized Crime Task Force (OCTF) has now taken down 25 large drug trafficking gangs, made more than 580 felony narcotics arrests, and seized more than $1.5 million and more than 2,000 pounds of illegal drugs since 2011. In the past several months alone, Attorney General Schneiderman’s SURGE (Suburban and Upstate Response to the Growing Epidemic) Initiative has resulted in 260 alleged traffickers and dealers taken off the streets.
- Urging health insurance companiesto review their coverage and payment policies that contribute to the opioid epidemic, as well as sending letters to the country’s three largest pharmacy benefit managers requesting documents, data, and other information regarding how they are addressing the opioid crisis.
The matter is being handled by Assistant Attorney General Carol Hunt and former Assistant Attorney General Michael Reisman, under the supervision of Senior Enforcement Counsel Kathleen Konopka, of the Social Justice Division and Attorney General’s Health Care Bureau Chief Lisa Landau. Data Scientist Katie Rosman and Researcher Anushua Choudhury from the Department of Research & Analytics assisted with the case. The Health Care Bureau is a part of the Social Justice Division, led by Executive Deputy Attorney General for Social Justice Matthew Colangelo and Chief Deputy Attorney General Alvin Bragg.”
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