When I spoke of regulatory perils that MSLs face when engaging with key opinion leaders, members of our MSL community said:
“The legal & compliance barriers/rules that are so pervasive within today’s Med Affairs Departments are out of control. Lawyers and regulators understand little of what really happens in a call; instead the perception has been developed that MSLs are out there pushing off-label uses.”
I frequently hear statements like above. The medical science liaison role may no longer be novel – but it is clearly still not well understood by the companies’ own legal and regulatory internal stakeholders.
These internal stakeholders then write the rules that govern how MSLs “should” work, based on their own perception of what MSLs are out there doing.
“Hi Jane , we are tackling this very issue right now.”
If you find yourself struggling with the same challenges of balancing “proactiveness” and “responsiveness”, you’re not alone. There are companies that have tried to formulate a compliant path to clinical communication through their MSLs, but at the end of the day, it is difficult for any MSL director or MSL manager to know exactly what each medical science liaison is saying out there, and whether any of their liaisons may be engaged in otherwise “risky communication”.
“I quite commonly hear people in R&D and Medical stating that since they are not with the sales and marketing department they can talk about anything… They usually defend themselves with the statement, ‘I’m not within sales, and I don’t intend to sell by my information.'”
This is true: medical affairs personnel aren’t alone in deeming themselves “different” by virtue of separation from overt sales and marketing objectives.
Notice I said “overt”. Just because you’re not in sales and marketing, doesn’t mean you don’t run the same risk that you’ll automatically face by being an employee of a commercial entity; a commercial entity made to adhere to strict government rules about “how” certain information should be communicated, and what proof must be supplied.
In fact, KOLs themselves may struggle with the idea that when they speak on companies’ behalf: they have to adhere to a different set of standards – one that pharma companies must abide in the eyes of regulators. These KOLs who are speakers and presenters on companies’ behalf are no longer free to speak “freely” as if they are clinicians talking among themselves. At least… they shouldn’t be.
“I believe the industry must have a set of boundaries to protect itself from the kind of fiasco Pfizer experienced with a liaison and Neurontin. On the other hand industry must make a decision if they want to develop a long term peer to peer relationship with KOLs or just answer therapeutic questions. The later can be done from an office and a phone.”
At the heart of MSLs’ effectiveness is the art of engaging in a scientific exchange that allows the companies to form the type of collaborative relationships with thought leaders that can make a difference in the way patients are treated and their lives saved. This is not a trivial undertaking. Regulators understandably want to control how pharmaceutical, device, and diagnostic manufacturers should communicate with healthcare providers who then make patient care decisions.
Some companies believe that requiring their MSLs to communicate on certain “scientific message platforms” would empower their MSLs to focus on what conversations would be appropriate an important. Others believe that communication should be organic, and let the KOLs take the lead.
But as MSLs, would you want your company to tell you “how” you should start a scientific exchange with your KOLs and what you should talk about? Or would you rather your KOLs “take the lead?”
Email me and tell me what you think!