A.G. Schneiderman Announces Settlement With Purdue Pharma That Ensures Responsible And Transparent Marketing Of Prescription Opioid Drugs By The Manufacturer
Purdue Pharma Agrees to Important Business Practice Changes That Can Help Protect Public Against Dangers Associated With Overprescribing Of Painkillers, Opioid Addiction Epidemic
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 Purdue Pharma, L.P. (“Purdue”), a pharmaceutical manufacturer of the long-acting opioid, OxyContin. The agreement strengthens and makes permanent an internal Purdue program aimed at preventing its sales staff from promoting the powerful painkiller to health care providers who may be involved in abuse and illegal diversion of opioids. The agreement also requires Purdue to disclose financial relationships with any individuals, including doctors and other health care professionals, who appear on the company’s “unbranded” websites that endorse the benefits of pain treatment, including the website www.inthefaceofpain.com.
“Over the past two decades, New York has experienced a sharp increase in opioid addiction and that has coincided with the substantially increased sale of oxycodone,” Attorney General Scheiderman said. “The public health crisis created by opioid overprescribing in New York remains pervasive and extremely dangerous. My office will work to ensure that prescription drugs are marketed and prescribed responsibly – and that consumers get the information they need about the risks of addiction to painkillers.”
Between the 1990s and 2011, prescriptions of oxycodone more than doubled in the U.S. and sales of the product increased more than tenfold. Between 2008 and 2011, OxyContin, the company’s brand name for its long-acting oxycodone pills, accounted for approximately 10% of the total oxycodone prescriptions in New York State. During this time period, according to the New York City Department of Health and Mental Hygiene, 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, with oxycodone accounting for 53% of those prescriptions.
Between 1997 and 2011, there was also 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.
Purdue, like many drug companies, employs sales representatives who visit physicians’ offices to encourage them to prescribe the company’s products to their patients, with the representatives receiving a bonus based on the number of prescriptions written. Purdue’s Abuse and Diversion Detection Program (ADD), sometimes referred to as “Region Zero,” requires its sales representatives to report to the company any facts that suggest a health care provider to whom it markets opioids may be involved in the abuse or illegal diversion of opioid products. When a provider is reported under the program, Purdue conducts an internal inquiry regarding the provider to determine whether he or she should be placed on a “no-call” list. If a provider is placed on this list, Purdue sales representatives may no longer contact the provider to promote the company’s opioid products.
The Attorney General’s investigation, which began in December 2013, revealed that in certain instances, Purdue may have failed to take the necessary steps to ensure that their sales representatives: (a) properly flagged all professionals who were potentially involved in the abuse and diversion of opioids, and (b) stopped calling on providers on the company’s “no-call” list.
The Attorney General’s investigation further found that Purdue’s unbranded pain management website, www.inthefaceofpain.com suggests that its content is neutral and unbiased, but that many advocates appearing on the site were paid by Purdue. The site contains testimonials from several dozen “advocates,” many of whom are health care providers, advocating for more pain treatment. The website failed to disclose that over the course of six years, Purdue paid almost $231,000 to eleven of the advocates.
The agreement requires important disclosures on any unbranded websites maintained by Purdue, including www.inthefaceofpain.com. As a result of this agreement, consumers will be able to identify those providers and other individuals who appear on these websites promoting pain management and have a financial relationship with Purdue. The company will also provide on these sites information regarding the risks of opioids, including the risk of addiction.
Under the terms of the New York agreement, Purdue, headquartered in Stamford, Conn., will continue to implement the ADD program in New York for so long as it markets OxyContin in the state. The agreement strengthens this program by outlining additional measures Purdue must adopt to ensure it does not promote its opioid products to providers who may prescribe these drugs inappropriately or illegally. Such measures include adding new “red flags” that will trigger an internal investigation by Purdue, and requiring Purdue to proactively identify providers who should be reviewed for potential placement on their “no call list.” Sales representatives must now file reports about providers who may not be abiding by I-STOP, New York’s signature law requiring New York health care providers to consult a database of a patient’s prescription history before prescribing a controlled substance, including narcotic painkillers.
The agreement further ensures that sales representatives do not contact providers on the “no call” list by imposing such safeguards as: (a) requiring representatives to check the “no-call” list before contacting a provider, (b) subjecting representatives to potential disciplinary action for contacting such providers, and (c) not counting prescriptions of Purdue opioid products by such providers towards sales representatives’ bonuses.
Significantly, the agreement also requires Purdue’s sales representatives who market Purdue opioid products to health care providers to ask whether the provider has completed an FDA-approved training program regarding the appropriate prescribing of opioids, and to provide information about such training. Purdue will also provide, upon request, information regarding addiction treatment resources to providers to whom it markets its opioid products.
As part of the settlement, the company will pay $75,000 in penalties and costs.
The OAG 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 OAG has prosecuted many health care providers who illegally prescribed and diverted opioids. The OAG has also aggressively enforced laws that require parity in health plan coverage of mental health and addiction treatment. The OAG’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 Attorney General Michael D. Reisman, 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.