Posted by David Restainoon August 01, 2012
A recent decision by a federal court of appeals emphasizes the responsibility of managers to ensure that persons within their control do not market prescription drugs for off-label uses. Anyone involved in compliance should take note.
The case relates to three corporate officers of Purdue Frederick Company, which was alleged to have “misbranded” OxyContin by marketing it as less addictive, less subject to abuse & diversion, and less likely to cause tolerance and withdrawal. Such misbranding violates the federal Food, Drug and Cosmetic Act. Among other extreme financial punishments, the officers received a 12-year exclusion from participating in federal health care programs by the Department of Health and Human Services (HHS). They appealed and – although not successful in overturning the debarment – the officers were successful in having its length remanded back to the lower court for further proceedings.
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The case relates to three corporate officers of Purdue Frederick Company, which was alleged to have “misbranded” OxyContin by marketing it as less addictive, less subject to abuse & diversion, and less likely to cause tolerance and withdrawal. Such misbranding violates the federal Food, Drug and Cosmetic Act. Among other extreme financial punishments, the officers received a 12-year exclusion from participating in federal health care programs by the Department of Health and Human Services (HHS). They appealed and – although not successful in overturning the debarment – the officers were successful in having its length remanded back to the lower court for further proceedings.
To read rest of blog click here.