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Indiana will receive $4.5M in off-label marketing settlement

August 30, 2012

Indiana Attorney General Greg Zoeller announced Thursday that the state will get nearly $4.5 million from Janssen Pharmaceuticals Inc. to settle claims that the company illegally marketed its drug, Risperdal.

The overall settlement is a record $181 million, which will be distributed to 36 states, including Indiana, and the District of Columbia. Zoeller says it is the largest consumer protection-based pharmaceutical settlement ever reached.

The complaint was filed in New York, which alleged that from 1998 through at least 2004, Janssen Pharmaceuticals engaged in deceptive and misleading practices in marketing anti-psychotic drugs Risperdal, Risperdal Consta, Risperdal M-Tab and Invega for off-label uses.

Johnson & Johnson, the parent company of Janssen, agreed to change its marketing of the drugs and end promoting “off-label” uses of the drugs not approved by the U.S. Food and Drug Administration. The settlement also outlines how Janssen must report clinical research, among other things.

“As part of being the watchdog for consumers, it is the Attorney General’s responsibility to ensure pharmaceutical companies are not marketing drugs for unapproved uses to boost sales,” Zoeller said. “Today’s multistate agreement should send a strong message that off-label marketing is illegal and will not be tolerated.”

Federal law prohibits pharmaceutical manufacturers from promoting their products for off-label uses, but physicians may prescribe drugs for those uses.  

 

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