Purdue fined USD 635m over misleading OxyContin marketing

US pharmaceutical company, Purdue Pharma, has been fined USD 635m in criminal penalties for its "aggressive and fraudulent" marketing campaign for its cancer pain drug, OxyContin (oxycodone controlled-release), which has been linked to crime, addiction and death from overdose.

The fine of USD 634.5m has been quoted as the third largest ever against a pharmaceutical company. A six-year investigation ended on 10 May in a federal courtroom in south-west Virginia, an area of the state infamous for its abuse of the so-called "hillbilly heroin".

Purdue started marketing the opiate in 1995 in a time-release formula which the company claimed in its marketing materials that the controlled-release technology in the pill made it safe for pain management by avoiding potential misuse. However, abusers of the drug simply crushed the tablets and either inhaled or injected the powder, rendering the time-release technology useless.

The total fine, although large, was still less than half the yearly peak sales of OxyContin, which were over USD 1bn. According to documents read out in court, Purdue made a gross total of USD 10.2bn in sales of OxyContin from 1995 to 2006, seeing total profits to 2004 of around USD 2.8bn.

Prosecutors at the US District Court in Abingdon described how OxyContin was "misbranded":

• Purdue sales reps told doctors that OxyContin produced no appreciable euphoria, compared with other painkillers and so was less prone to abuse

• In its marketing statements, Purdue quoted a study which claimed that patients taking less than 60mg of OxyContin a day could quit with no withdrawal symptoms, despite clinical data showing that a number of patients had experienced ìcold turkeyî. Purdue suppressed the results out of a concern that it would impact sales

• Reps also told doctors that the drug was less likely to be abused than other painkillers and could be used to screen for recreational drug users

Purdueís President and CEO, Michael Friedman; chief legal officer, Howard Udell; and former vice-president of medical affairs, Paul Goldenheim, pleaded guilty at the court on 10 May in a plea bargain to avoid jail sentences. All three were fined a total of USD 24.5m to be given to the state of Virginia's Medicaid fraud unit. Terms of the plea agreement called for an independent monitor to monitor the company's compliance with FDA guidelines and federal laws.

Purdue expressed regret for any misleading statements it made about OxyContin prior to 2001: "During the past six years, we have implemented changes to our internal training, compliance and monitoring systems that seek to assure that similar events do not occur again."

In response, the FDA has informed healthcare professionals of criminal charges and civil liabilities brought against Purdue. Read the 2007 safety summary, including a link to the FDA press release at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#OxyContin