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April 16, 2015 Healthcare Fraud

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 evaluate cost-effectiveness of current medical treatments, making it more difficult to envision solutions for the global health crisis.

In considering the financial burden of healthcare that many nations are facing, the WHO has encouraged drug companies to be more transparent with their price schemes. Moreover, it discussed the role of off-label marketing in the overall reduction of healthcare costs for nations facing difficulties.

“Off-label marketing” refers to a drug company’s promotion of a medication for the treatment of a medical condition for which the efficacy of that drug was not actually tested by a nation’s drug evaluation agency. In many instances, a drug may have multiple productive uses, but is only approved for use in patients with a specific affliction, while scores of other patients could benefit from the drug, as well.

In Europe, off-label use of drugs is generally not allowed. In the United States a doctor may, in some instances, prescribe a drug for an off-label use – the manufacturer, however, cannot promote it for the off-label use. In discussing the potential benefits of off-label marketing, the WHO report detailed a recent off-label marketing controversy surrounding the macular degeneration drug known as bevacizumab. According to the report, bevacizumab is not approved for use in patients suffering from age-related macular degeneration. However, it has proven to be wildly successful when used for this off-label purpose. The approved treatment for the same condition costs approximately 40 times more than bevacizumab, and patients who are unable to afford the treatment eventually experience total blindness.

Off-Label Marketing in the United States & The False Claims Act

Off-label marketing is quite prevalent in the U.S. and physicians are generally permitted to prescribe medications as necessary to treat the symptoms and effects of various illnesses and conditions. However, the federal False Claims Act has become a major factor in preventing off-label marketing as pertaining to enrollees in government healthcare benefits programs.

As we have covered in several past posts, pharmaceutical companies face False Claims Act liability when engaging in off-label marketing. In one ongoing case, Pfizer is facing False Claims Act scrutiny for allegedly marketing its antipsychotic drug Geodon – which is approved for the treatment of schizophrenia symptoms – for the treatment of bipolar children and the elderly. In another case, Teva Pharmaceuticals agreed to pay tens of millions of dollars to settle with both the federal government and several states over allegations of off-label marketing of the drug clozapine. Alarmingly, this drug is considered by psychiatrists to be a drug of “last resort” for the treatment of schizophrenia; however, Teva is alleged to have touted its use for the treatment of agitation in elderly dementia patients.

Off-Label Marketing: Pros and Cons

As described in the WHO report, there may be benefits to engaging in off-label marketing and use of drugs; however, the practice is not without its dangers. Pharmaceutical companies choosing to maximize profits over patient safety is a major concern and the pharmaceutical company is not barred from bringing the drug to the FDA for approval for the treatment of another condition. In this way, the FDA regulations and the False Claims Act strike a balance that protects patient health above pharma profits.

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