Deleterious Duo: Off-Label Sales Communications and Product Liability
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Maureen Shaffer
Vice President, Life Sciences, Prolifiq
www.prolifiq.net/lifesciences
Executive Editor & Publisher, Good Promotional Practices www.goodpromotionalpractices.com
•In pharma, “we are seeing people driving 67 in the middle lane as opposed to 92 in the fast lane.” “That makes our job harder.”
•“You still see a fair amount of wild west behavior in some of these smaller companies, particularly in the biotech and medical device sectors, where you are not necessarily going to have a whole compliance team set up that is deeply immersed in these issues.”
Rx 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.
Educate–Your reps need to know what uses are approved/cleared and what is off-label. –Before your quarterly sales meetings, review current best practices and
emerging uses occurring in the field–Surgeons will often come back from a society meeting having talked to their
colleagues about new uses; be prepared for this.
Practice–Have your reps role-play these situations at sales meetings so people know how
best to address off-label marketing issues. –Practice how to handle an unsolicited request--or whatever company-approved
process exists for handling these off-label questions--and still provide the education needed for the physician and staff.
Participate–Make sure that you are spending time in the field with your reps, listening to
their presentations and continuously coaching them. –Encourage them to call you with any questions about safely and appropriately
When something is a habit, the PFC signals the STN at a very low rate
–Conserves cognitive resources–Make decisions more efficiently
When doing something different, as simple as looking at dots in a different order, your PFC signals your STN at a very high rate
–Doing something new or making a difficult decision requires motivation. Without significant motivation, we default to our habits.
Prefrontal cortex (PFC) , the “Decider”Controls decision making, including inhibition of reflexive responsesSubthalamic nucleus (STN), the “Doer” Controls motivation