A raft of lawsuits centered in New Jersey allege that Schering-Plough Corp. offered bribes, kickbacks and other incentives to doctors to get them to prescribe its hepatitis and cancer drugs for uses not approved by the FDA.
The drugs at the center of the litigation are Intron A and Temador. Intron A, approved to treat hepatitis, has been prescribed for such off-label uses as superficial bladder cancer. Temador, approved for certain brain tumors, has been widely used for other illnesses like metastic melanomas.
The plaintiffs are hoping to get a leg up as a result of the federal investigation into Schering's marketing practices that began in 2001 and culminated in the plea deal in Massachusetts on Aug. 29, 2006.
The deal called for Schering Sales to pay a criminal fine of $180 million and to plead guilty to one count of conspiracy to make false statements to the government in response to a July 2001 inquiry by the FDA about Schering's off-label marketing activities.
Schering Sales is also excluded permanently from participating in federal health care programs, and it admitted it was guilty of the broader criminal conduct charged in a related criminal information.
Prosecutors contended that between 1999 and 2003, the Schering companies got doctors to prescribe certain drugs for off-label uses by buying them off with money -- as much as hundreds of dollars per patient -- preceptorships, advisory boards and entertainment.
Other alleged means included placing "Schering-funded physician assistants in busy physician practices."
Much more at Law.com
The drugs at the center of the litigation are Intron A and Temador. Intron A, approved to treat hepatitis, has been prescribed for such off-label uses as superficial bladder cancer. Temador, approved for certain brain tumors, has been widely used for other illnesses like metastic melanomas.
The plaintiffs are hoping to get a leg up as a result of the federal investigation into Schering's marketing practices that began in 2001 and culminated in the plea deal in Massachusetts on Aug. 29, 2006.
The deal called for Schering Sales to pay a criminal fine of $180 million and to plead guilty to one count of conspiracy to make false statements to the government in response to a July 2001 inquiry by the FDA about Schering's off-label marketing activities.
Schering Sales is also excluded permanently from participating in federal health care programs, and it admitted it was guilty of the broader criminal conduct charged in a related criminal information.
Prosecutors contended that between 1999 and 2003, the Schering companies got doctors to prescribe certain drugs for off-label uses by buying them off with money -- as much as hundreds of dollars per patient -- preceptorships, advisory boards and entertainment.
Other alleged means included placing "Schering-funded physician assistants in busy physician practices."
Much more at Law.com
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