Drug Maker Will Pay Fine for Promoting Off-Label Use - New York Times: "Drug Maker Will Pay Fine for Promoting Off-Label Use
In a story that has largely run under the radar screen, today's settlement has the capacity to change how the pharmaceutical industry markets its products now in the future. The following is an account from the Associated Press.
By THE ASSOCIATED PRESS
Published: August 30, 2006
BOSTON, Aug. 29 � The Schering-Plough Corporation agreed on Tuesday to pay $435 million and plead guilty to conspiracy to settle a federal investigation into marketing of its drugs for unapproved uses and overcharging Medicaid for certain drugs.
Schering-Plough said it would pay $255 million to resolve civil aspects of the previously disclosed investigation. A subsidiary, the Schering Sales Corporation, will pay a criminal fine of $180 million and plead guilty to one count of conspiracy to make false statements to the government. The agreement is subject to court approval.
Schering-Plough said the settlement resolved an investigation by the Justice Department and the United States attorney�s office in Boston that began before a new management team took over at the company in April 2003.
�With this agreement, we are putting issues from the past behind us,� said Brent Saunders, senior vice president for compliance and business practices.
Shares of Schering rose 53 cents, to $20.94, on Tuesday.
The agreement comes two years after Schering-Plough agreed to pay $346 million to settle charges that it paid a kickback to a health insurer to protect the market for its allergy drug Claritin.
The investigation that led to Tuesday�s settlement began in 2001.
Investigators found evidence that Schering-Plough marketed drugs for off-label uses. Off-label uses have not been approved by government regulators, although doctors can individually choose to prescribe drugs for those purposes.
One such drug was Temodar, which the Food and Drug Administration in 1999 approved to treat"
In a story that has largely run under the radar screen, today's settlement has the capacity to change how the pharmaceutical industry markets its products now in the future. The following is an account from the Associated Press.
By THE ASSOCIATED PRESS
Published: August 30, 2006
BOSTON, Aug. 29 � The Schering-Plough Corporation agreed on Tuesday to pay $435 million and plead guilty to conspiracy to settle a federal investigation into marketing of its drugs for unapproved uses and overcharging Medicaid for certain drugs.
Schering-Plough said it would pay $255 million to resolve civil aspects of the previously disclosed investigation. A subsidiary, the Schering Sales Corporation, will pay a criminal fine of $180 million and plead guilty to one count of conspiracy to make false statements to the government. The agreement is subject to court approval.
Schering-Plough said the settlement resolved an investigation by the Justice Department and the United States attorney�s office in Boston that began before a new management team took over at the company in April 2003.
�With this agreement, we are putting issues from the past behind us,� said Brent Saunders, senior vice president for compliance and business practices.
Shares of Schering rose 53 cents, to $20.94, on Tuesday.
The agreement comes two years after Schering-Plough agreed to pay $346 million to settle charges that it paid a kickback to a health insurer to protect the market for its allergy drug Claritin.
The investigation that led to Tuesday�s settlement began in 2001.
Investigators found evidence that Schering-Plough marketed drugs for off-label uses. Off-label uses have not been approved by government regulators, although doctors can individually choose to prescribe drugs for those purposes.
One such drug was Temodar, which the Food and Drug Administration in 1999 approved to treat"
posted by Chris Placitella | 2:21 PM
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