Author: Mary Holloway
Although the news of pharmaceutical and medical device settlements in 2010 would lead you to believe otherwise, the rate of new qui tam filings has slowed and the accusations are focused more on subtle versus blatant violations according to an article in the Rx Compliance Report. This is a good sign for an industry that has been working hard trying to revise its marketing practices and eliminate off-label promotion.
Unfortunately, the case backlog from past conduct and their resulting settlements give the impression that blatant off-label promotion is still very present today. In reality, much of the egregious behavior occurred well in the past. The illegal conduct alleged in new qui tam cases is more subtle. Attorney Robert M. Thomas, Jr. comments in Rx Compliance Report:
“We are seeing people driving 67 in the middle lane as opposed to 92 in the fast lane.”1
Sara Bloom, Assistant U.S. Attorney in the U.S. Attorney’s Office in Boston reinforced this focus and points to the future of off-label prosecutorial focus stating that comparative claims along with:
“..considerations such as dosages and promoting for the side effects of a product rather than its approved use are now considered legitimate areas of investigation.” 1
While the flood of qui tam suits may have slowed due to tightened compliance, compliance teams and sales training colleagues need to ensure that they understand how subtle off-label behavior looks and sounds. More importantly, they need to communicate this in a clear and memorable way to their sales force. You do not want representatives guessing whether their selling statements are on or off-label.
If you need a few reasons to shore up your training, below is a look at the top 2010 pharmaceutical and medical device settlements relating to off-label marketing.
|Company||Settlement Amount||2010 Settlement Date||Product|
- 1Rx Compliance Report, “Federal prosecutors report slowdown in the filing of new fraud claims, say less egregious violations cited”, Vol. IX, Issue 9/July 21, 2010
- Big Pharma behaving badly: A timeline of settlements (FiercePharma)