Author: Sean McCarthy
WOW, that one got my attention!!
One of my colleagues here at Good Promotional Practices wrote in last week’s blog of the banning of an executive from doing business with the federal government. So let’s do a quick recap of all the different ways that regulations are changing in the world of Medical Device Sales:
- The aforementioned executive is banned from doing business & resigns in the first salvo from HHS.
- Park Doctrine– FDA threatens to enact tighter regulation on Med device & Pharma.
- State AG’s aggressively pursuing physicians & hospitals over “off-label” marketing or referral strategies.
- Whistleblower lawsuits relating to Marketing practices from former employees.
- Multiple settlements associated with marketing/sales strategies through DOJ and many more still in process.
So, what are we to do? Well we need to start by asking ourselves a few questions because there is a lot at stake here including jail time, fines, shutdowns and now loss of careers.
- Is your Medical Device used “off-label” in any way? Are you sure? What about that exciting new use the reps were talking about at the last sale’s meeting?
- If so, are your Field Sales/Marketing departments promoting the product line for this use?
- Are you sure they are not promoting it for off-label use? Are they aware of the implications?
- Do you have a Promotional Review Committee (PRC) or similar in your company?
- Even if you don’t have a device used off-label are you sure your sales force knows the implications associated with their field activities? Either way you need to have a program in place…
The landscape is changing every day, and I fear that my colleagues out there in the field are not aware of the scrutiny our industry is under and just how much it has changed. Bottom line, we need to do things the right way, and if you don’t have someone teaching your field sales personnel what has changed in the field, can you be certain they even know if they cross the line?? I can assure you I’ve had conversations recently with seasoned professionals that were not aware of some of these changes, and the scrutiny that the industry is under.