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February 6, 2013

FDA Regulation of Off-label Drug Promotion Under Attack

Author Affiliations

Author Affiliations: Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School (Drs Kesselheim and Avorn); and Department of Health Policy and Management, Harvard School of Public Health (Dr Mello); Boston, Massachusetts.

JAMA. 2013;309(5):445-446. doi:10.1001/jama.2012.207972

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.