Endo Pharmaceuticals has agreed to pay a $200,000 fine and revamp marketing of its Opana ER tablet as part of a settlement announced today with the New York attorney general who accused the drug maker of improperly downplaying the risk of addiction associated with its opioid medicine.
Specifically, Endo must “cease all misrepresentations” about the drug, accurately describe the risk of developing an addiction, summarize clinical studies on its web site, and create a compliance program that will prevent its sales reps from promoting Opana ER to doctors who may be involved in illegal diversion.
In a statement, New York Attorney General Eric Schneiderman said his office found that Endo “improperly” marketed Opana ER as crush-resistant although the company’s own studies showed the pill could be crushed and ground, making it easier to abuse. And he said that Endo sales reps were instructed to “diminish and distort risks,” including the possibility of addiction.
We asked Endo for comment and will update you accordingly. [UPDATE: In a statement later sent us, Matthew Maletta, Endo’s executive vice president and chief legal officer, said “we… welcome the support and input from the New York Attorney General and other stakeholders as we continually evolve and improve our anti-abuse programs.”]
After Endo reformulated Opana ER in 2011 into a crush-resistant form, prescriptions fell precipitously from more than 1.2 million that year to approximately 660,000 in 2014, the most recent year for which data was available, according to research firm IMS Health.
The drop indicated that the street value fell, but some people were still snorting, chewing, or injecting the drug, according to Dr. Andrew Kolodny, chief medical officer at Phoenix House, a nonprofit that runs alcohol and drug abuse treatment and prevention programs, and the head of Physicians for Responsible Opioid Prescribing, an education and advocacy group.
“I think Endo got off very easily,” he said. “A $200,000 fine is inappropriate when the company falsely promoted its drug as safe and effective for chronic pain. Many people have been harmed. They became addicted or died of overdoses. I’m very disappointed with this outcome.”
The settlement comes amid intensifying efforts across the country to rein in opioid abuse. The prescription painkillers have increasingly been blamed for fueling addiction and crime, and for serving as a bridge to a growing heroin trade. Every day, 52 Americans die from overdoses of opioid painkillers, according to the US Centers for Disease Control and Prevention.
To cope, federal and state authorities are pursuing a number of efforts. The CDC, for instance, plans to issue new prescribing guidelines for primary care physicians. And the Food and Drug Administration recently vowed to overhaul its approach toward product labeling, convene more advisory committee meetings to review medicines, and bolster requirements for postmarketing studies.
One tactic has been to pursue drug makers in court.
Two years ago, the city of Chicago and two California counties alleged that several companies, including Endo, used a variety of tactics to persuade doctors to prescribe their painkillers, while also minimizing risks. These included editorial control over medical journal articles, paying influential doctors as speakers, and funding patient advocacy groups, among other things. Chicago officials recently revised their lawsuit, while the lawsuits in California have been delayed indefinitely.
Last December, Johnson & Johnson and Purdue Pharma agreed to pay a total of nearly $40 million to settle separate lawsuits filed by the Kentucky Attorney General who charged the companies with misleading consumers about the risks of their widely prescribed opioid painkillers. The companies were also named in the lawsuits filed by Chicago and the California counties.
And in a related development, a former Insys Therapeutics sales rep pleaded guilty to violating federal kickback laws in connection with an alleged scheme to boost sales of an opioid painkiller. The company is being probed by various federal and state agencies that doctors were encouraged to prescribe the drug for unapproved uses.