Drugs

Avanir Pharma Charged in Marketing Scheme

The government has charged Avanir Pharmaceuticals and four individuals with paying kickbacks to a physician to induce prescribing of its drug Nuedexta (dextromethorphan hydrobromide and quinidine sulfate), which is indicated for treating pseudobulbar affect (PBA), according to the U.S. Department of Justice. “Avanir has also agreed to pay over $95 million to resolve civil False Claims Act allegations of kickbacks as well as its false and misleading marketing of Nuedexta to providers in long term care facilities to induce them to prescribe it for behaviors commonly associated with dementia patients, which is not an approved use of the drug,” the government says.

The government contends that Avanir sought to capitalize on efforts by the Centers for Medicare and Medicaid Services to reduce the use of anti-psychotics on dementia patients in long-term care (LTC) facilities, based in part on CMS’s concern that anti-psychotics can be and have been used as a form of chemical restraint for residents. “Avanir did so by instructing its sales force to initiate discussions in LTCs regarding anti-psychotic use and how Nuedexta could be used to reduce a LTC facility’s reliance on anti-psychotics even though Avanir’s own studies demonstrated that the actual population of patients with PBA is limited,” it says. “In order to counter the objection by certain physicians that they had few, if any, patients that exhibited signs of PBA in their facilities, Avanir instructed sales representatives to provide false and misleading information that PBA patients could be exhibiting a wide variety of behaviors such as crying without tears, moaning, or making other inarticulate sounds, when, in fact, those symptoms are commonly observed in patients who have dementia but do not have a diagnosis of PBA.”

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome