Drug Maker Can Market Off-Label Use, Court Rules

Pharmacists may receive questions from patients about prescription fish oil Vascepa after its manufacturer won a court case against the FDA that will allow the company to market an off-label use.

The preliminary ruling in US District Court on August 7, 2015, stated that prohibiting Amarin Corp. from sharing truthful information about its triglyceride-lowering product would be a violation of the manufacturer’s free speech rights.

“This is the first decision, I think, that clearly and unequivocally rebuffs the government’s view that off-label promotion can be prosecuted, even if truthful and nonmisleading,” Joel Kurtzberg, a lawyer who represented Amarin, told The New York Times.

Amarin will now be able to market the use of Vascepa for treating slightly lower levels of triglycerides—an indication that the FDA has not approved. This would apply to patients with triglyceride levels around 200 to 499.

The FDA did not approve this use because it wanted more information about whether lowering triglycerides actually helped patients avoid heart disease or myocardial infarction.

While off-label use is common, manufacturers have traditionally not been able to market unapproved uses of their products.

The American Society of Health-System Pharmacists has several recommendations for pharmacists concerning off-label use. The organization believes that pharmacists should fulfill the role of patient advocate and drug information specialist, and also develop policies and procedures for handling prescriptions for off-label uses. For example, pharmacists may want to document the medical necessity of using a drug for an unlabeled indication.

In a JAMA Internal Medicine editor’s correspondence, Michael T. Rupp, PhD, RPh, of the Midwestern University-Glendale College of Pharmacy, described how off-label prescribing puts a pharmacist in a unique and somewhat difficult position. He noted the drug utilization review aspects of the Omnibus Budget Reconciliation Act of 1990, which mandates that pharmacists consider whether a prescription is appropriate and medically necessary. Dr. Rupp suggested that it would make sense for prescribers to provide pharmacists with clinical evidence for the off-label use of a medication.

Some opponents of off-label use suggest that “truthful information” can be interpreted in different ways, and off-label marketing may remove incentives for companies to conduct studies that show the drug’s efficacy for additional indications.

In the case of Vascepa, lawyers for pharmaceutical companies told The New York Times that it is currently unclear how this ruling will affect other manufacturers’ off-label promotions, in part because the FDA is expected to appeal this ruling. It has approximately 2 months to do so.