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Post date: March 3 2016

A.G. Schneiderman Announces Settlement With Endo Health Solutions Inc. & Endo Pharmaceuticals Inc. Over Marketing Of Prescription Opioid Drugs

Endo Will Cease Making False And Misleading Claims About The Narcotic Painkiller Opana ER

Endo Will Create A Program To Prevent Marketing Opioids To Health Care Providers Engaged In Abuse And Diversion

Schneiderman: My Office Is Committed To Preventing Opioid Abuse, Holding Drug Companies Accountable

NEW YORK - Attorney General Eric T. Schneiderman today announced an agreement with Endo Health Solutions Inc. and Endo Pharmaceuticals Inc. (“Endo”), which make and sell the long-acting opioid, Opana ER. The agreement requires Endo to cease all misrepresentations regarding the properties of Opana ER, to describe accurately the risk of addiction to Opana ER, and to summarize studies regarding Opana ER on its website. Endo must also create a program that will prevent its sales staff from promoting this powerful narcotic painkiller to health care providers who may be involved in the abuse and illegal diversion of opioids.

“The public health crisis created by improper opioid prescribing in New York remains pervasive and extremely dangerous,” said Attorney General Schneiderman. “My office is committed to ensuring that prescription drugs are marketed and prescribed responsibly – and that consumers get the information they need about the serious risks associated with painkillers, such as addiction.”

The use of prescription opioids to manage chronic non-cancer pain has increased ten-fold over the past 20 years in the United States, with a concomitant increase in opioid-related health problems. According to the New York City Department of Health and Mental Hygiene, between 2008 and 2011, the number of opioid painkiller prescriptions filled by New York City residents increased by 31%, from approximately 1.6 million to approximately 2.2 million. The resulting increase in the prescribing of opioids is associated with a sharp increase in the prevalence of opioid addiction, which in turn has been associated with a rise in overdose deaths and heroin use. According to the federal Centers for Disease Control and Prevention, in New York State, from 2003 to 2012, deaths involving opioid analgesics increased five-fold, from 179 in 2003 to 883 in 2012.

Endo, an Irish company with U.S. headquarters in Pennsylvania, makes a variety of prescription drugs. Endo’s opioid drug Opana ER has been widely abused in New York State. In May 2011, after a spike in opioid prescribing and abuse, Nassau County issued a Public Health Alert on the increasing abuse of Opana ER, warning the public and law enforcement of the dangers of associated with the drug. In July 2012, USA Today reported that Opana ER had become the drug of choice for people seeking narcotics, and that in Nassau County, hundreds of people each month were seeking treatment for addiction to Opana ER.

As a result of concerns regarding the role of Opana ER in the larger opioid abuse epidemic and Endo’s marketing practices, the Office of the Attorney General launched an investigation of Endo, focusing on Opana ER. The Attorney General found that Endo improperly marketed Opana ER as designed to be crush resistant, when Endo’s own studies showed that the pill could be crushed and ground. This may have bolstered Opana ER sales, but provided a false sense of security to health care providers and their patients. The Attorney General also found that Endo improperly instructed its sales representatives to diminish and distort risks associated with Opana ER, including serious dangers involving addiction.

The Attorney General’s investigation also revealed that Endo had no meaningful program in place to ensure that its sales representatives were not encouraging health care providers engaged in abuse and diversion to write more prescriptions for Opana ER. Numerous New York health care providers who were heavily “detailed” by Endo were subsequently convicted of illegal prescribing of prescription opioids. The Attorney General also found that Endo made unsupported claims comparing Opana ER to other opioids, and failed to disclose accurate information regarding studies addressing the effects of Opana ER.

In light of Endo’s deceptive and unlawful conduct, the Office of the Attorney General compelled Endo to change its practices. Endo has agreed to the following measures:

  • Provide truthful and complete information regarding addiction risks associated with Opana ER.
  • Stop improperly marketing Opana ER as being crush resistant.
  • Create an Abuse and Diversion Detection Program that requires Endo’s sales representatives to report to the company health care providers it suspects of engaging in abuse and illegal diversion of opioids, and for Endo to cease marketing opioids to problem prescribers.
  • Post results of clinical studies on Endo’s website.
  • Encourage health care providers to seek training on appropriate opioid prescribing practices.
  • Provide health care providers with information about addiction treatment resources for their patients.

Furthermore, the Attorney General has also imposed a $200,000 penalty on Endo for its unlawful conduct.

The Attorney General’s Office has taken a multi-pronged approach to combatting New York’s prescription drug abuse epidemic. Attorney General Schneiderman’s ground-breaking law, “Internet System for Tracking Over-Prescribing Act,” or “I-STOP,” which became effective in August 2013, has reduced “doctor-shopping” by 75%. The Attorney General’s Office has prosecuted many health care providers who illegally prescribed and diverted opioids. The Attorney General’s Office has also aggressively enforced laws that require parity in health plan coverage of mental health and addiction treatment. The Attorney General’s Community Overdose Prevention (“COP”) Program, which equips New York law enforcement agencies with a life-saving heroin overdose antidote, has saved more than 100 lives.

The investigation of this matter was conducted by Assistant Attorneys General Michael D. Reisman and Carol Hunt, of the Attorney General’s Health Care Bureau, which is led by Bureau Chief Lisa Landau. The Health Care Bureau is a part of the Social Justice Division, led by Executive Deputy Attorney General for Social Justice Alvin Bragg.

A copy of the settlement can be read here.

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