RICO Suits Challenge Off-Label Drug Marketing

Law360, New York (August 3, 2015, 10:07 AM EDT) -- Physicians often prescribe drugs for uses not approved by the U.S. Food and Drug Administration. Although this so-called "off-label" use is generally lawful and may be medically sound, the cost of expanding uses may pose challenges for insurers, who must carefully manage coverage decisions. Moreover, pharmaceutical companies that promote drugs for off-label uses may be subject to criminal and civil liability. Because drug reimbursement often involves government payors, such as Medicare and Medicaid, both the government and private relators have for years pursued False Claims Act cases alleging that off-label promotion resulted in inappropriate reimbursements. In 2014, the government recovered more than $235 million from pharmaceutical companies in FCA settlements relating to off-label promotion, but similar settlements in recent years have ranged into the billions....

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