TY  - JOUR
T1  - FDa regulation of off-label drug promotion under attack
AU  - Kesselheim AS, Mello MM, Avorn J
Y1  - 2013/02/06
N1  - 10.1001/jama.2012.207972
JO  - JAMA
SP  - 445
EP  - 446
VL  - 309
IS  - 5
N2  - 
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.

SN  - 0098-7484
M3  - doi: 10.1001/jama.2012.207972
UR  - http://dx.doi.org/10.1001/jama.2012.207972
ER  -