Monday, May 28, 2012

Topic1: Introduction- Proactivity vs. Risk in HCP Interactions

Each week or so on Medical Affairs Focus we identify a topic of interest to MA leaders and share a series of short posts on the topic. 

This week’s topic is Proactivity versus Risk in HCP Interactions.  For the purpose of this discussion, we will use the US regulatory regime.  This is a topic that has increasingly been important to my clients as they attempt to chart a course for their field outreach teams. The degree of acceptable proactivity is directly tied to the value that the field team brings to the organization (which will be a topic for another week).  As organizations grow more risk averse, they are increasingly ratcheting back the proactivity of their field outreach.  We’ll discuss the following:

As always, please add your experience and questions in the comments.

Legal Note:  All information and interpretations presented are only the opinion of the author(s) who are not lawyers. And, even if we were lawyers, given the wide range of interpretations of the current regulations you would still need to get the input from your own compliance organization.  Simply put – your mileage may vary.


  1. [...] Where things start getting “trickier” is around product-specific education.  Some organizations allow it and some do not.  For more in depth discussion on this topic, see this post. [...]

  2. [...] this is certainly the only way to discuss topics that are not suitable for proactive engagements (see this for further discussion on proactivity), for those topics that are suitable for proactive discussion it places an undue burden on the KOL [...]

  3. [...] MA is allowed to discuss off label topics only under very specific circumstances – when they receive an unsolicited request.  MA is allowed to have some proactive discussions which are educational and non-promotional about related non-label topics depending on the rules of each organization.  See a detailed discussion of this here. [...]

  4. [...] is on all the current focus we place on “proactivity”.  I have discussed this topic in detail here, here, and here.  I bemoaned the unclear state of the current regs here. Now we are imagining a [...]

  5. [...] take the time to look over some of our archives.  We have discussed a range of topics including MSL proactivity, KOL identification, MedComm/SciComm groups, MA at Product Launch, Global MA and MA’s [...]

  6. [...] take the time to look over some of our archives.  We have discussed a range of topics including MSL proactivity, KOL identification, MedComm/SciComm groups, MA at Product Launch, Global MA and MA’s [...]


Please leave your thoughts as well as suggestions for other topics.