After four years of unrelenting pursuit by the Food and Drug Administration, the Purdue pharma of the US gave in, admitting it had made false claims about their popular painkiller Oxycontin.
They have agreed to pay up $634.5 millions for making false claims about the drug to boost sales and also pleaded guilty to charges of playing down Oxycontins addictive and euphoric properties.
Purdue pleaded guilty to a felony count of misbranding a drug with intent to defraud and mislead.
Under the agreement, it will pay a $600 million settlement, including a criminal fine, restitution to government agencies, and more than $276 million in forfeiture. In a separate civil settlement, Purdue will pay $100.6 million.
According to an investigation by the Food and Drug Administration (FDA)s Office of Criminal Investigations (OCI), the drug company trained its sales force to represent OxyContin as a drug that did not cause euphoria and was less addictive than immediate-release opiates; and allowed healthcare providers to have the mistaken notion that OxyContin was less addictive than morphine.
Over the last few years there have been instances of hundreds of overdose deaths linked to OxyContin's main ingredient oxycodone. The drug was marketed as a miracle pain reliever; less addictive and less subject to abuse than similar medications. However, it was later found that its contents could be highly addictive and even fatal.
Purdue Pharma also made false representations about the difficulty of extracting oxycodone, the active ingredient, from the OxyContin tablet, and labeled the drug as providing fewer peaks and valleys than with immediate-release oxycodone, the OCI said.
U.S. Attorney John Brownlee said, "With its OxyContin, Purdue unleashed a highly abusable, addictive, and potentially dangerous drug on an unsuspecting and unknowing public."
"For these misrepresentations and crimes, Purdue a
nd its executives have been brought to justice."
OxyContin is a trade name for oxycodone, and is a time-release painkiller that can be highly addictive. In that variety the ingredients are released over a period of time for sustained effect.
The drug is meant to be swallowed whole and digested over 12 hours. It was later found that the pills can produce a heroin-like high if crushed and then swallowed, snorted or injected.
According to the Drug Enforcement Agency (DEA), the number of deaths linked to the use of OxyContin jumped 400 percent between 1996 and 2001. Still, in 2001, Purdue executives testified they had just become aware that the drug was being abused.
In its statement, Purdue Pharma said it accepted responsibility for false statements made about the drug's risks of addiction, abuse, withdrawal and tolerance six years ago, but added, "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."
Generic firms, including Teva and Endo, had sold generic versions of Oxycontin, but have since stopped making the products and are not accused of any wrongdoing in connection with promoting their products, reports said.
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