Tim Mackey and Bryan Liang: 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

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.

"On August 7, 2015, the US District Court in Amarin v FDA handed down a ruling that the US Food and Drug Administration (FDA) lacked the authority to prohibit nonmisleading forms of off-label speech.1 When a drug is approved by the FDA for a specific indication, licensed clinicians are nevertheless free to prescribe it for any clinical use they see fit. In fact, off-label drug use (ie, prescribing medications for a different disease or medical condition, different route of administration, and/or different dosage than that approved by the FDA) is relatively common, with a 2006 study estimating that 21% of commonly used drugs are prescribed off-label.2 Despite regular off-label use of prescription drugs (including high rates in certain patient populations and conditions such as pediatrics, cancer, and psychotic disorders), manufacturers are only allowed to engage in product promotion for the indication approved on the label.3 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."