Orphan Medical, a subsidiary of California, USA-based drugmaker Jazz Pharmaceuticals, has pleaded guilty in the US District Court in Brooklyn, New York, to a charge of felony misbranding relating to the off-label promotion of Xyrem (sodium oxybate).
In July 2002, the Food and Drug Administration cleared Xyrem for the treatment of the muscular condition cataplexy, subsequently approving it as a therapy for excessive daytime sleepiness. However, it was also classified by the Department of Health and Human Services as a potential "date rape" drug due to its active ingredient gamma-hydroxybutyrate. Orphan admitted that it had promoted the drug to physicians for off-label uses, including in the treatment of fatigue, chronic pain, weight loss depression, bipolar disorders and Parkinson's disease.
In addition, the firm said that it had paid a psychiatrist thousands of dollars in fees to promote Xyrem in speeches across the USA. The court was told that, at one such lecture in Great Neck in New York, the psychiatrist in question advocated use of the product for off-label indications, and had disputed claims that it was a "date rape" drug, according to a Bloomberg report.
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