FDA fines US drug firm $634m over painkiller misleads

Mumbai: The US Food and Drug Administration (FDA) has imposed a $634 million fine on a pharmaceutical company and three of its top executives for misleading the public about the risks of addiction associated with a powerful painkiller.

FDA refused to approve the claims of Stamford, Connecticut-based Purdue Pharma that its drug, an opioid called Oxy-Contin, was less harmful to health than rival medicines, attorney John Brownlee said.

The three officials - its president, chief lawyer and former medical officer - pleaded guilty to false claims.

"Purdue unleashed a highly abusable, addictive and potentially dangerous drug on an unsuspecting public," Brownlee said, adding, "For these misrepresentations and crimes, Purdue and its executives have been brought to justice."

Of the $634 million fine, about half will go to the US government, $160 million to other federal and state agencies and $130 million to pay off private civil claims against Purdue.

Privately held Prude had earlier agreed to pay out nearly $20 million to settle complaints that it had encouraged doctors to overprescribe the drug.

The company had known as far back as 1995 that doctors were concerned about the drug''s potential for abuse. Yet, it went on to supply false information to its sales representatives that the drug had less potential for addiction and abuse than other painkillers.

The drug had led to 146 deaths in 2002 and contributed to a further 318, according to information available with the US drug authorities.