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Violation Tracker Individual Record

Company: Shire Pharmaceuticals LLC
Current Parent Company: Takeda Pharmaceutical
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Penalty: $56,500,000
Year: 2014
Date: September 24, 2014
Offense Group: healthcare-related offenses
Primary Offense: off-label or unapproved promotion of medical products
Secondary Offense: False Claims Act and related
Mega-Scandal: Improper Drug Marketing
Violation Description: Shire Pharmaceuticals LLC agreed to pay $56.5 million to resolve civil allegations that it violated the False Claims Act as a result of its marketing and promotion of several drugs for certain uses despite a lack of clinical data to support such claims and overstated the efficacy of the drugs.
Level of Government: federal
Action Type: agency action
Agency: Food and Drug Administration referral to the Justice Department
Civil or Criminal Case: civil
HQ Country of Current Parent: Japan
Ownership Structure of Current Parent: publicly traded
Major Industry of Current Parent: pharmaceuticals
Specific Industry of Current Parent: pharmaceuticals
Source of Data: (click here)
Source Notes: If an online information source is not working, check the Violation Tracker Data Sources page for an updated link.
Current parent company note: Parent-subsidiary relationship is current as of the most recent revision listed in the Update Log.