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Manufacturer to Pay $20 Million for Improperly Promoting a Sleep Disorder Drug

Leading US drug manufacturer, Jazz Pharmaceuticals, has agreed to pay $20 million to settle a federal investigation into claims that one of its subsidiaries illegally marketed a narcolepsy drug for other unapproved uses.

Narcolepsy is a sleep disorder marked by sudden, uncontrollable urges to sleep, causing an individual to fall asleep at inappropriate times.

The case is the latest of several federal drug-marketing probes involving Bay Area firms (in northern California) and is centered on the sales activities of Orphan Medical, a Minnesota company Jazz bought in 2005.

As part of the settlement - which Jazz will pay over the next five years - Orphan executives pleaded guilty to illegally promoting their drug Xyrem.

That medication has been approved by the U.S. Food and Drug Administration (FDA) for treating people suffering from narcolepsy only.

But the settlement agreement signed by Jazz and the U.S. Attorney's Office in New York said Orphan's sales representatives promoted Xyrem for so-called off-label purposes, meaning uses not approved by the FDA.

Among other things, Orphan's employees were accused of promoting the drug as a treatment for chronic pain, weight loss, depression, bipolar disorders and Parkinson's Disease.

The employees also were accused of paying a New York psychiatrist thousands of dollars to attend speaking engagements and tout Xyrem for unapproved uses.

Xyrem is the prescription version of the street drug, gamma hydroxybutyrate, a quick anesthetic with serious risks of overdose, including coma and death.

Xyrem's active ingredient is also federally classified as a date-rape drug because it can be easily slipped into a person's drink to render them unconscious.

Federal authorities said the illegal marketing occurred from January 2003 through March of this year. Jazz bought Orphan in June of 2005. '"/>




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