While other companies have been hit with heftier fines for falsely marketing their drugs, Purdue Pharma's $700.6 million agreement with the Department of Justice over OxyContin promotions has had a profound impact on the management of the company, with guilty pleas from two of the firm's top executives.

In announcing the guilty plea May 10, John Brownlee, U.S. Attorney of the Western District of Virginia, said Purdue's "misrepresentations and crimes sparked one of our nation's greatest prescription drug failures." He declared that OxyContin (oxycodone extended-release) was "the child of marketers and bottom line financial decision making."

The DoJ's investigation of Purdue was headed up by Brownlee and involved assistance from FDA's Office of Criminal Investigations. The government found that Purdue engaged in illegal schemes to increase sales of OxyContin by downplaying the addictive potential and abuse liability associated with the Schedule II controlled substance.

The Purdue settlement is among the largest for off-label promotion violations. The government's first major case was brought against TAP Pharmaceuticals in 2001, in which TAP paid $875 million to settle claims of fraudulent drug pricing and marketing of Lupron (leuprolide).

Among other cases, Serono paid $704 million over its promotion of the AIDS-wasting drug Serostim (somatropin) (¹ Also see "Serostim $704 Mil. Settlement Is Largest For Off-Label Marketing Case" - Pink Sheet, 24 October, 2005., p. 10). In its landmark settlement, Pfizer paid $430 million to resolve allegations over its nerve pain drug Neurontin (gabapentin) (² Also see "Warner-Lambert GMP Conviction Plays Role In Neurontin Case" - Pink Sheet, 17 May, 2004., p. 5).

However, it is unusual for company executives to be held personally accountable. Earlier this month, Serono officials were acquitted of offering kickbacks to doctors for writing Serostim prescriptions.

Purdue pled guilty in Abingdon, Va., district court to a felony count of misbranding a drug with intent to defraud and mislead. As part of the plea, Purdue will pay a $600 million settlement, including a criminal fine, restitution to government agencies and over $267 million in forfeiture. In a separate civil settlement, Purdue will pay $100.6 million to the U.S. government.

In addition, Purdue's Chief Executive Officer Michael Friedman, General Counsel Howard Udell and former Chief Medical Officer Paul Goldenheim, who left the company in 2004, pled guilty to a misdemeanor charge of misbranding OxyContin from 1996 through 2001.

The company has also agreed to a Corporate Integrity Agreement extending for five years and requiring the company to retain an independent monitor and staff to review Purdue's compliance with the agreement.

Despite media attention and warnings from health care professionals regarding the abuse potential of the drug, Brownlee said Purdue continued to push a fraudulent marketing campaign to promote OxyContin.

"In the process, scores died as a result of OxyContin abuse and an even greater number of people became addicted to OxyContin; a drug that Purdue led many to believe was safer, less abusable and less addictive than other pain medications on the market," Brownlee said in a statement. "With today's conviction of the maker of OxyContin, we have finally brought to justice the main component in this ring of abuse."

The number of oxycodone-related deaths increased 400 percent between 1996 and 2001, according to the Drug Enforcement Administration, while at the same time the number of annual prescriptions for OxyContin increased from 300,000 to nearly 6 million.

Among the allegations made by the U.S. Attorney's Office are that Purdue trained sales reps to falsely inform health care providers that it was more difficult to extract oxycodone from the OxyContin tablet and that it led to fewer chances of addiction compared to immediate-release opioids. The government also said Purdue trained sales reps to inform health care providers that patients could stop therapy without experiencing withdrawal and that OxyContin did not cause euphoria.

For its part, Purdue issued a statement the same day acknowledging that employees at the company did make statements inconsistent with the FDA-approved prescribing information for OxyContin, but said those statements were made prior to July 2001 and violated written company policies.

"We accept responsibility for those past misstatements and regret that they were made," Purdue said.

"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 2001, FDA sent Purdue a warning letter saying the company's ads omitted potentially fatal safety risks about the drug (³ Also see "OxyContin Ads Will Highlight Boxed Warning In Response To FDA Objection" - Pink Sheet, 27 January, 2003., p. 11). In response, Purdue updated labeling for OxyContin to include a "black box" warning highlighting the abuse potential for oxycodone and reminding prescribers of the appropriate patient population for the drug. That warning noted that OxyContin has an abuse liability similar to morphine.

At the time, Purdue Pharma also undertook a campaign to educate physicians about the risks of OxyContin, including a series of professional advertisements showcasing the abuse potential of drugs from thought leaders in medical and law enforcement.

The Government Accountability Office issued a report to Congress in 2004 on the abuse potential of OxyContin and recommended that NDAs for opioids include risk management plans.

OxyContin is indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time.

Sidney Wolfe, director of Public Citizen's Health Research Group, said the OxyContin case is unlike other off-label promotion investigations, which usually involve encouraging doctors to prescribe products for indications that have not been approved by FDA. "The gist of this one is danger," he maintained, since the violative marketing involved downplaying safety information, and hundreds of people died from taking OxyContin. "It falls into a different category of violation."

Wolfe decried the penalty, saying the company should have paid a larger portion of the profits it reaped from illegal marketing of OxyContin, "closer to billions of dollars," and that Purdue execs should have been given jail sentences. Other people are imprisoned for much smaller illicit drug offenses, he said. The fact the perpetuators here face no jail time shows "if you have money there is a different standard of justice."

- Jessica Merrill (j.merrill@elsevier.com) & Brenda Sandburg (b.sandburg@elsevier.com)

Purdue Execs Plead Guilty To Misbranding OxyContin; Company Pays $700 Mil.

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