RT Journal
A1 Kesselheim AS, Mello MM, Avorn J
T1 FDa regulation of off-label drug promotion under attack
JF JAMA
JO JAMA
YR 2013
FD February 6
VO 309
IS 5
SP 445
OP 446
DO 10.1001/jama.2012.207972
UL http://dx.doi.org/10.1001/jama.2012.207972
AB 
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.