Connecticut Attorney General Demands Federal Action On OxyContin

July 31, 2007 -- Connecticut Attorney General Richard Blumenthal today, in congressional testimony, demanded federal action on his three-year-old petition to require stronger label warnings on OxyContin and urged stronger criminal sanctions to prevent future tragedy.

More than 300 people have died from OxyContin overdoses, while Purdue Pharma has made hundreds of millions of dollars in profits, Blumenthal said.

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Blumenthal said the FDA cannot justify further inaction in light of recent convictions of Purdue Pharma L P, the OxyContin maker, and former executives for misleading OxyContin prescribers about the drug’s dangers.

In a letter to the FDA this week and today’s testimony, Blumenthal said the FDA has failed to act for three years on his petition – submitted January 23, 2004 – to require Purdue to revise its OxyContin labeling, expressly warning prescribers of the increased occurrence of side effects or potentially serious adverse reactions resulting from off-label prescribing at more frequent dosing intervals.

In testimony submitted today to the Senate Committee on the Judiciary, Blumenthal urged Congressional action to:

* require the FDA to mandate stronger label warnings, as sought by his outstanding petition

* classify as a federal felony any knowing distribution of a product that causes serious injury or death

* require mandatory prison terms for any individual convicted of such felony

“Corporate officials who knowingly and willfully market a product in a manner that directly causes death or serious injury should be held to the same standard as an individual who kills or injures another person,” Blumenthal said. “OxyContin is the latest grim example of corporate greed and arrogance causing death and serious injury. More than 100 years ago, a similar corporate mindset led to many federal and state consumer protection and employee rights laws. The question we must ask is whether these laws offer sufficient deterrence – and the answer clearly is no.

“Purdue Pharma conducted focus groups and determined that physicians would be reluctant to prescribe OxyContin because its main ingredient, oxycodone, is so addictive. Purdue Pharma also determined that physicians were looking for effective pain medication with low risk of addiction. Although Purdue Pharma knew that OxyContin was highly addictive, it instituted a comprehensive marketing campaign that continuously marketed OxyContin to health care providers as a pain management drug with low risk for addiction.”

Blumenthal said strengthening federal deterrence is vital, but Congress should also ensure more effective oversight by federal agencies to prevent such tragedies. Blumenthal’s office, after a year-long investigation of Purdue Pharma and after uncovering alarming evidence that the company knew the drug was being mis-prescribed by physicians but not taking appropriate action to warn them, filed a detailed Citizens Petition with the FDA in January 2004.

“More than three years have passed and the FDA has yet to rule on – or even substantively answer – the petition. Early and aggressive FDA action on this petition may have saved lives. The FDA’s glaring and galling failure to act demonstrates the need for wide-ranging reform of the agency.

“The FDA turned its back on its serious responsibility with regard to OxyContin. Despite all the evidence available to the FDA – through public media reports and private government channels – the FDA never even required Purdue Pharma to add a black box warning or implement a Risk Management Plan until 2001, five years after the drug was launched.

“In the face of criminal convictions and a nationwide civil settlement – not to mention death and drug addiction – further FDA inaction is incomprehensible and inexcusable.”

To avoid similarly damaging delays in the future, Blumenthal also urged Congress to require the FDA to rule on future citizen’s petitions within six months of filing (unless the petitioner agrees to an extension).

Blumenthal also requested additional information from the FDA, including:

* the status of the FDA’s review and when we might expect a ruling

* whether any preliminary decisions or conclusions have been reached regarding the petition; and

* whether any additional information could be provided by Blumenthal’s office to the FDA to assist it in coming to a resolution on this issue.

Source: Connecticut Attorney General