Off-Label Marketing Becomes Global Issue as World Health Organization Encourages Cost-Effectiveness
Amid global shortages of life-saving medical resources, the United Nations’ World Health Organization has released a report focusing on various cost-saving tactics for member nations to consider while strategizing medical policy. At the heart of the matter, the WHO found that most nations do not have procedures in place to […]
The ongoing off-label marketing debate has given rise to several False Claims Act lawsuits commenced by a single whistleblower. In a qui tam cause of action filed in November, 2009, whistleblower Frank Solis has alleged that Millennium Pharmaceuticals and Merck, Inc. engaged in the controversial sales technique known as off-label […]
Shire Pharmaceuticals to Pay $56 Million to Settle False Claims Act Allegations
According to a recent announcement by the Department of Justice, Shire Pharmaceuticals has agreed to pay $56 million to settle claims it fraudulently marketed the popular attention-deficit drug Adderall and thereafter submitted claims to U.S. government healthcare programs for reimbursement. The allegations differ from the oft-cited problem of “off-label marketing,” […]
Vascular Solutions to Pay $520,000 to Settle False Claims Act Allegations
In a recent False Claims Act settlement, Minneapolis-based Vascular Solutions, Inc. (“VSI”) has agreed to pay $520,000 to the federal government in order to settle claims it unlawfully marketed its products for the treatment of varicose veins. The company, which has admitted no liability or guilt in the matter, agreed […]
Off-Label Marketing Case Involving Calgene Survives Despite Defendants’ Motion to Dismiss
Earlier this month, a False Claims Act case against drug maker Calgene was unsealed, revealing allegations of off-label marketing with regard to its controversial cancer drug Thalomid. The case, in which the government opted not to intervene, has been subject to several months’ worth of procedural wrangling by both parties. […]
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