New York Attorney General Eric T. Schneiderman announced an agreement with Endo Health Solutions, Inc. and Endo Pharmaceuticals, Inc. (collectively, “Endo”), which make and sell Opana ER, a long-acting opioid.
Opana, one of Endo’s prescription drugs, was long abused in New York State. In May 2011, for example, after a spike in opioid prescribing and abuse, Nassau County issued a Public Health Alert on the increasing use and abuse of Opana ER, warning both the public and law enforcement of the dangers associated with the prescription drug. In July 2012, USA Today reported that Opana ER was actually 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 both Opana ER’s role in the larger opioid abuse epidemic and Endo’s marketing practices, the Office of the Attorney General opened an investigation into 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 actually showed that the pill could be crushed and ground up. While this may have bolstered Opana ER sales, it also may have provided a false sense of security to healthcare 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.
Endo also claimed that Opana ER was distinguishable from its main competitor, OxyContin, because patients who take Opana ER need less rescue medication than those who take OxyContin. This claim, made by sales representatives in sales calls, was not supported by any clinical evidence or study.
The Attorney General’s investigation found that Endo had no meaningful program in place to ensure that its sales representatives were not encouraging healthcare providers who are engaged in abuse and diversion to write more prescriptions for Opana ER. This was of particular concern because multiple New York healthcare providers who were heavily “detailed” by Endo were subsequently convicted of illegally prescribing prescription opioids (see p. 10-12 of Settlement).
According to Attorney General Schneiderman, “The public health crisis created by improper opioid prescribing in New York remains pervasive and extremely dangerous. 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 Office of the Attorney General has compelled Endo to change its practices in light of their “deceptive and unlawful conduct.”
Endo must implement the following corrective measures:
- Provide truthful and complete information regarding addiction risks associated with Opana ER;
- Stop improperly marketing Opana ER as crush resistant;
- Create an Abuse and Diversion Detection Program that requires Endo’s sales representatives to report to the company any healthcare providers they suspect of engaging in abuse and illegal diversion of opioids;
- Post results of clinical studies on Endo’s website; and
- Provide healthcare providers with information about addiction treatment resources for their patients.
- Inform NY providers both in writing and orally to participate in the FDA ER-LA REMS Prescriber Education each year
Attorney General Schneiderman also imposed a $200,000 penalty on Endo for its unlawful conduct.
Settlement Specifics
In addition to the aforementioned items, the Settlement went through the findings that Attorney General Schneiderman found, including that in addition to an annual salary, Endo’s sales representatives were eligible for a bonus based partly on the number of Opana ER prescriptions written by healthcare providers they were permitted to call upon. Attorney General Schneiderman felt as though such a bonus scheme may create an incentive to encourage more Opana ER prescribing.
The Settlement also mentions that Endo neither admitted nor denied Attorney General Schneiderman’s findings in the Settlement and that Endo did cooperate with the Attorney General investigation.
The Settlement also laid out specific plans and requirements for the aforementioned Abuse and Diversion Detection Program, including the filing of a written report with Endo’s Legal Department when sales representatives or medical liaisons observe or learn of situations that may suggest that a healthcare provider whom they contact for the purpose of promoting Opioid Medications may be involved in the abuse or diversion of opioids.
This settlement is not the light at the end of the tunnel for Endo. Earlier this month, they said they are still facing other regulatory probes and lawsuits related to its opioid sales and marketing practices.