Off-Label Marketing

As a pharma rep who has been through several sales product trainings, off-label marketing is a big no-no! It can cause a great deal of trouble for the company and employee, resulting in major lawsuits and expenses.   Although the pharmaceutical industry does self-govern via PhRMA, setting industry standards and guidelines to uphold, it does not mean everyone follows them.  Unfortunately, off-label marketing probably happens more often than I'd like to admit as a member of the industry.

Well in a recent case, U.S. v. Caronia, the court has called one pharma rep's off-label marketing a form of protected speech. Touche. This left legal experts and the FDA in search of SOME kind of response, but unfortunately they came up short.  The FDA did respond saying it "does not believe that the Caronia decision wil significantly affect the agency's enforcement of the drug misbranding provisions of the Food, Drug, and Cosmetic Act (FiercePharma)." This makes sense, as one trial in a specific region is probably not enough, drugs are marketed on a global level, through many different channels.

So one way to look at this is that another off-label-promotion-is-free-speech claim is making its way through the courts.  This isn't "new" news. There may not have been an FDA appeal this time, but I guarantee it is not the last we hear of it.

Read more: FDA won't appeal free-speech ruling on off-label marketing - FiercePharma