FDA Regulation of Off-label Drug Promotion Under Attack

In 2005, Alfred Caronia worked as a sales representative for the drugmaker Orphan Medical promoting the central nervous system depressant sodium oxybate (Xyrem),¹ which had been approved by the US Food and Drug Administration (FDA) to treat narcolepsy. With the company's knowledge and approval,² Caronia promoted the drug to physicians for numerous unapproved (“off-label”) indications—including insomnia and fibromyalgia—and claimed the drug was safe in elderly and pediatric patients, despite warnings on the label that safety was not established in those populations.