Jazz Pharmaceuticals has agreed to pay $20 million over five years to settle a US Government probe into the off-label promotion by its subsidiary, Orphan Medical, of its sleep disorder product Xyrem, which contains the active ingredient better known as the ‘date-rape’ drug.

A US district court in New York approved the civil and criminal settlement related to the actions of Orphan Medical, a company Jazz acquired in 2005. As part of the settlement, Jazz pleaded guilty to one count of felony misbranding.

Xyrem (sodium oxybate) is approved for conditions including excessive daytime sleepiness in narcolepsy patients and cataplexy. Shelley Lauterbach, a sales representative for Orphan Medical, filed a suit on behalf of the government alleging sales representatives at the company were also told to promote off-label uses of the drug for weight loss, depression, bipolar disorder and Parkinson’s disease. According to the US Justice Department, an unidentified psychiatrist who received fees from Orphan Medical also promoted the drug in a lecture in Great Neck, New York, for unapproved uses.

“This case is especially troubling, not only because it involves a drug containing GHB [but because] Orphan teamed up with a medical professional and employed deceptive marketing tactics in order to advance its illicit marketing scheme,” said US Attorney Roslynn R Mauskopf.

Black-box warning

Xyrem, whose active ingredient is gamma hydroxybutyrate or GHB, the clear odourless liquid that will knock a victim out when slipped into a drink, carries an Food and Drug Administration black-box warning, and has clear prescribing information.

‘GHB is a chemical that has been abused and misused’, the prescribing information warns. ‘Abuse and misuse of Xyrem can lead to serious medical problems, including seizures, loss of consciousness, coma and death’.

Under the court settlement, Jazz must cooperate with the government in other investigations and prosecutions of illegal marketing. It must also hire a compliance officer, develop written standards, review its claims to federal healthcare programmes and submit reports to the US Health and Human Services Department’s Office of the Inspector General.