After Amarin v FDA: What Will the Future Hold for Off-label Promotion Regulation?

1: 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: tmackey@ucsd.edu.
2: 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."

TimAllenMDJD