Off-label use: How do you deal with competitors who are taking business through compliance violations?

Last week, three executives for a major orthopedic trauma company received jail sentences for their roles in the company’s promotion of unauthorized use of a product.  Nobody thought that the punishment would extend beyond fines but it’s clear that DOJ wants to send a message to the industry.

Sales representatives know the approved indications for the products they sell like they know the names of their children, or at least they should.  Doctors I’ve spoken to often learn about off-label uses from sales reps, not in a blatant violating-the-law-way, but with a subtle wink and a nod along with a disclaimer that they can only promote the approved indications.  I’ve heard statements such as, “I can only tell you the approved indications.  However, Doctor, you may decide to use this or any product as you determine is best for your patient.”  With all of the companies I have worked with, if there was a compliance officer who got wind of this, that sales rep would be toast!  But of course, word never gets back to the company…until there is a problem.

In the case I mentioned at the beginning of this post, three patients died as a result of the non-approved use of a product.  No one is going to assume all of the blame in such a dire situation when there is room to pass it or share it with a related party.

If you’re a sales rep, a sales manager, or apparently even the CEO of the company, when the shit hits the fan, you’re dispensable.  When a patient is harmed and your name is associated with off-label use, you can at best kiss your job good-bye and at worst you’ll be paying a fine and allowing the federal prison system to cook your meals and provide your clothing.

Some sales reps argue that their competitors hint at off-label use all the time with their customers, and without off-label use they can’t compete.  Seems like you have some choices:

  1. Ignore what your competitors are doing and sell your product’s approved indications only.
  2. Report your competitors to try and level the playing field and make them play “fair.”
  3. Risk your career and jail time because nothing matters more than getting the sale.

Will the jail sentences that were handed down last week  make you more aware of how you promote your products?


What do you think are the best ways to handle competitors who are taking business from you with off-label product use by your mutual customers?


Should you remind your customers that any sales representative who promotes or suggests the use of a product off-label is breaking the law?

Please comment and feel free to do so anonymously.