OxyContin Maker Swallows Fines Over Dosing

[baudmax]

OxyContin Maker Swallows Fines Over Dosing
Purdue Pharma Denies Charges, But Settles

http://www.local6.com/health/13287566/detail.html

POSTED: 3:23 pm EDT May 9, 2007
HARTFORD, Conn. -- Drug maker Purdue Pharma L.P. has agreed to pay $19.5 million to 26 states and the District of Columbia to settle complaints that it encouraged physicians to overprescribe its powerful painkiller OxyContin.

State attorneys general complained that the company urged doctors to prescribe OxyContin every eight hours instead of the 12-hour dose approved by the U.S. Food and Drug Administration.

"We're raising the bar on off-label marketing and other promotion tactics that lead to abuse and diversion of prescription drugs," Connecticut Attorney General Richard Blumenthal said. "Our combined state legal campaign will stop this manufacturer from promoting a powerful drug for inappropriate uses."

Purdue denied Tuesday that it had been pushing inappropriate dosing.

"Purdue representatives promote the 12-hour dosing to physicians because it is the dosing interval utilized in the clinical studies the company submitted to the FDA," the Stamford-based company said in a statement.

Among other things, the settlement requires Purdue to abide by warnings on a packaging insert, stop marketing the drug for use in ways other than approved by the FDA, and improve internal controls.

"It has always been Purdue's written policy that promotion of its products must adhere to FDA-approved prescribing information for those products as well as applicable laws," the company said in a statement.

The company also agreed to stop basing bonuses for its sales staff solely on the volume of OxyContin prescribed.

OxyContin is a time-release painkiller that can be highly addictive. Designed to be swallowed whole and digested over 12 hours, the pills can produce a heroin-like high if crushed and then swallowed, snorted or injected.

The Bush administration's anti-drug plan singles out OxyContin as one of the nation's most-abused prescription drugs.

Tuesday's settlement also resolves allegations that Purdue Pharma failed to fully disclose the abuse risks of Oxycontin, Blumenthal said.

The other states taking part in the settlement are Arizona, Arkansas, California, Illinois, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Montana, Nebraska, Nevada, New Mexico, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Vermont, Virginia and Wisconsin.

"Some medicines can do more harm than good when used the wrong way," said North Carolina Attorney General Roy Cooper. "Drug makers need to give doctors and patients accurate information about their drugs or expect to face the consequences."

Connecticut will receive $719,500 in the settlement, and $100,000 will be used to create a state program to track prescription patterns, and help identify abuse, Blumenthal said.

[bcubed]

Further developments in today's Centre Dialy Times (www.centredaily.com)

OxyContin Maker, Execs Plead Guilty

Abingdon, VA: The company that makes the painkiller OxyContin and three of its current and former executives pleaded guilty Thursday in federal court to criminal charges that the firm had misled doctors and patients when it claimed that the drug was less likely to be abused than traditional narcotics.

The company, Purdue Pharma, agreed to pay $600 million in fines and other payments to resolve the criminal charge of "misbranding" the product, one of the largest amounts ever paid by a drug company in such a case. The three executives also pleaded guilty to misbranding the drug. Together, they agreed to pay $34.5 million in fines.

(Attributed to "wire reports")