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Penalties for Misbranding OxyContin Are Too Little

May 10, 2007

Penalties for Misbranding OxyContin Are Too Little

Statement of Sidney M. Wolfe, MD, Director, Health Research Group of Public Citizen

The $634 million in criminal and civil penalties – including guilty pleas by three current and former Purdue Frederick executives – for misbranding the potent narcotic OxyContin, send an important message to the drug industry that this kind of malicious, death-dealing behavior will not be tolerated.

However, the message could have been much stronger.

From 2000 through 2006 alone, according to data from Drug Topics, the news magazine for pharmacists, there have been $9.6 billion in retail U.S. sales of OxyContin. It was one of 25 top-selling drugs from 2000 to 2005 (it was the 11th largest selling prescription drug in 2003). Thus the government should have forced the company to disgorge far more of its ill-gotten profits in this case.

Hundreds of thousands of people are languishing in jail for relatively minor drug possession or distribution crimes involving illegal drugs or, in a smaller number of cases, prescription drugs such as OxyContin. Why have the three wealthy Purdue executives, who have pleaded guilty to orchestrating this dangerous promotional campaign, escaped jail time, and why are they paying merely $34.5 million in penalties?

The damage to the public from these white-collared drug pushers surely exceeds the collective damage done by traditional street drug pushers. Why do we have such a double standard of justice?

In a Jan. 17, 2003, warning letter from the Food and Drug Administration to the company concerning illegal advertising of OxyContin, a large number of similar charges were leveled at the company, including overstating the safety profile of the drug by not referring to the large number of fatalities it had caused and overselling the benefits. Because the FDA lacks the authority to impose civil monetary penalties for any prescription drug violation, the company did not have to pay a cent. The amendments to the law passed in the Senate yesterday concerning the FDA’s powers would grant such authority for false and misleading advertisements.