Author: Sean McCarthy
Last Sunday’s Philadelphia Inquirer reported on the indictments of four high-level medical device executives for off-label marketing practices. The indictments mark a next step in the enforcement of off-label marketing practices in the US.
We have heard and written about the many fines being leveled against pharmaceutical and medical device companies for these practices–we’ve even heard threats that executives might have charges brought against them. Now, federal prosecutors in Philadelphia have indicted two company presidents, a vice president and a director of clinical regulation at Synthes, an orthopedic medical device company based in Pennsylvania. The company has already been fined $23.7 million for the off-label promotion of its Bone Cement (classified as a medical device by the FDA) but prosecutors are also seeking jail time for those they believe responsible and accountable for the illegal behavior. They point to at least three incident-related patient deaths of which the company was aware.
“We are concerned that the providers that engage in health care fraud may consider civil penalties the cost of doing business. As long as the profit from fraud outweighs those costs, abusive corporate behavior is likely to continue,” said Lewis Morris of the HHS Office of Inspector general regarding the case. Translation: there needs to be a higher price to pay and that means taking away your freedom.
This particular case goes back nearly a decade, but it makes you wonder if the practice of using executives as a severe deterrent against “what not to do” will become the norm. And truly, if patients are dying out there, someone should be held accountable for those actions. Ask yourself three questions :
- Are there any rogues out there willing to break the rules to make numbers and boost profits?
- How can you make sure this does not happen in your company?
- Are your promotional practices and compliance department in line with field activity and training for your sales force and management?
I think everyone has taken for more notice recently, and many have cleaned up their acts as a result. What about you?
- Top Three Off-Label Marketing Strategies and Tactics (goodpromotionalpractices.com)
- 3 Tips to Keep Your Reps On-Message vs. Off-Label (goodpromotionalpractices.com)