WASHINGTON, D.C. - The federal Food and Drug Administration needs to put stronger warning labels on the controversial prescription painkiller OxyContin, Connecticut Attorney General Richard Blumenthal said Tuesday.
During his testimony before Congress, Blumenthal said the FDA can not continue to ignore his three-year-old petition that calls for drug manufacturer Purdue Pharma to revise its warning label.
The addiction capabilities of OxyContin have been the subject of much litigation, including a plea that led to $634 million in fines during the criminal case against Purdue Pharma that alleged the company misrepresented how addictive its drug could be.
More recently, several former executives were convicted of misleading the drug's customers. In civil courts, Purdue Pharma has settled with several state attorneys general, including West Virginia's Darrell McGraw. McGraw and the federal government are battling over who is entitled to much of the $10 million settlement.
During his testimony, Blumenthal also urged stronger criminal sanctions to prevent a repeat of the OxyContin controversy in the future. He would like to see any knowing distribution of a product that causes serious injury or death be made a federal felony that carries a mandatory prison term.
"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.
Blumenthal filed his petition in Jan. 2004 after he says he uncovered evidence that Purdue Pharma knew the drug was being wrongly prescribed by physicians.
"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," Blumenthal said.
"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."