Department of Anesthesiology, Division of Global Public Health, Department of Medicine, University of California, San Diego School of Medicine, San Diego, CA; Joint Masters Program in Health Policy and Law, University of California, San Diego School of Medicine and California Western School of Law, San Diego, CA; Global Health Policy Institute, La Jolla, CA. Electronic address: email@example.com.
Global Health Policy Institute, La Jolla, CA.
"When manufacturers engage in
promotion for any indication, dosage, or
administration outside the FDA approval,
they engage in illegal off-label promotion.4
However, the lines between illegal and
permitted off-label promotion are now being
blurred in the wake of the Amarin decision,
which is likely to have a lasting impact on
future drug promotion practices, regulatory
and enforcement activities, and the role of
the physician in patient care."