Author: Sean McCarthy
It was reported last week in various media outlets that a little known doctrine could be used by FDA to come after company CEOs who have no knowledge or intent of illegal behavior. The Park Doctrine would potentially allow FDA to hold company CEOs responsible for the actions of their underlings, such as promoting their products for off-label use. So imagine a sales rep doing something they may not even realize is wrong because compliance isn’t sufficiently strong, or they just don’t know exactly how to convey the proper information to their customer. Who is at fault? If FDA pursues this line it could be your CEO…and also every management person in between the sales rep and the CEO.
Commenting on this announcement at a conference in Washington was FDA’s deputy litigation chief Eric Blumberg:
“It’s clear we’re not getting the job done with large, monetary settlements,” Blumberg said. “Unless the government shows more resolve to criminally charge individuals at all levels in the company, we cannot expect to make progress in deterring off-label promotion.”
This is certainly turning up the heat on the off-label marketing discussion. FDA is pulling out all the stops to regulate the marketing of products in the Device & Pharma arena. How is your company going to ensure that everyone in the organization is compliant?
Coming next blog – FDA doesn’t regulate the physician & hospitals right? Strap in, they may have found a way.