While Word on Health has repeatedly written about the fines being levied against pharmaceutical companies, we were somewhat surprised to learn from the Philadelphia Inquirer of the indictments of four high-level medical device executives for off-label marketing practices.
Although, we’d heard threats that industry executives might have charges brought against them, many people thought these were nothing more than empty words.
These indictments therefore mark a bold step in the enforcement of off-label marketing practices in the US and will undoubtedly serve as a warning to others.
In these landmark cases, Federal prosecutors in Philadelphia indicted two company Presidents, a Vice President and a Director of Clinical Regulation at Synthes, a Pennsylvania-based orthopedic medical device company.
The company has already been fined $23.7 million for the off-label promotion of its Bone Cement 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 resulting from off-label promotion and use of the product.
“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 (OIG) regarding the case.
While we all wonder if using pharma executives as a deterrent against “what not to do” will become the norm or whether this was simply a “one off”, it’s clear that there are now very real and very personal consequences to off-label promotion.
For people in the pharmaceutical industry maybe this news should serve as a “heads up” that it’s not enough to just talk about compliance, you really have to practice it at every level of the organization.
What’s your reaction to this development? Let us know.