Narcotic Maker Guilty of Deceit Over Marketing

The company that makes the painkiller OxyContin and three of its current and former executives pleaded guilty Thursday in federal court here to criminal charges that it had misled doctors and patients when it claimed 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, including its president and its top lawyer, also pleaded guilty to misdemeanor charges of misbranding the drug. Together, they agreed to pay $34.5 million in fines.

The guilty plea — by Purdue Frederick, an affiliate of Purdue Pharma — is the latest of a number of cases brought by the Justice Department against pharmaceutical makers that accuse them of misbranding, a broad statute that makes it a crime to put false or misleading information about a drug on its label or in ads, or to promote it for unapproved use.

Plea Agreement as to The Purdue Frederick Company (pdf)
Plea Agreement as to Howard R. Udell (pdf)
Plea Agreement as to Michael Friedman (pdf)
Plea Agreement as to Paul D. Goldenheim (pdf)

READ MORE @ New York Times
READ MORE @ Scientific American

Feds seek to punish drug companies for off-label marketing

U.S. District Court Judge Patti Saris had seen cases like this before, and she was fed up.

Another pharmaceutical company was in her court, waiting to be slapped with a multi-million-dollar fine for marketing its drugs for uses that had not been approved by the federal Food & Drug Administration.

“You can't thumb your nose at the FDA,” Saris said. She sentenced Schering Sales Corp. and its parent company, Schering-Plough Corp. earlier this year to pay $435 million to settle allegations it lied to the government about drug prices and illegally promoted the drugs Temodar and Intron A for the treatment of cancers for which they were not approved.

READ MORE @ Associated Press