From Brian Liang and Tim Mackey: After Amarin v FDA: What Will the Future Hold for Off-label Promotion Regulation?

Mayo Clin Proc. 2016 Jun;91(6):701-6. doi: 10.1016/j.mayocp.2016.02.024. Epub 2016 Apr 12.

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

Mackey TK1, Liang BA2.

Author information

• 1Department 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.
• 2Global Health Policy Institute, La Jolla, CA.

"Although the Food, Drug, and Cosmetic Act (FDCA) does not specifically delineate FDA powers to prohibit off-label promotion, the FDA has maintained that by marketing offlabel, a manufacturer violates the FDCA by introducing a 'misbranded' drug into interstate commerce."