Monday, May 28, 2012

Topic1: Proactivity vs. Risk- The Spectrum of Proactivity

Note: This analysis is entirely based on the US regulatory regime.

The reason proactivity is such an interesting topic is the wide range of standards found in the industry today.  Similarly sized organizations often have very different interpretations of what is and is not acceptable in terms of proactive outreach with health care providers (HCPs).  As a result, it’s easiest to think of the degrees of proactivity as a spectrum. The spectrum looks something like this:

Many organizations have interpreted the regulations in different ways given different situations, so as a practical matter organizations tend to jump around a bit on the spectrum.  And this excludes a range of proactive discussion topics that are potentially acceptable but highly guided, examples include:

  • In support of company-sponsored clinical trials

  • In support of acquiring the services of an HCP as a consultant (for example to serve on an Advisory Board)

  • The providing of reprints following Good Reprint Practice

No Proactivity

Believe it or not, there is at least one major pharma company that currently employs this standard.  It calls into account the value of the MA field organization unless it is primarily focused on the exclusions above.  It also makes it critical to have a strong link between the phone- and internet- based information request systems and the MA field organization to make sure that they are responding effectively.

Disease State Proactivity

This is the degree of proactivity that most “conservative” interpretations of the regulations tend to find acceptable.  Many organizations limit their MA field organizations to this degree of proactivity.

The focus of this outreach is to educate HCPs on the current science behind a disease state without focusing on any particular treatment option.  This can be tremendously valuable to a pharma company as many practicing HCPs find it highly challenging to keep up with all the latest science and may not realize the strengths and challenges with the given treatment options.

Supportive of Label Proactivity

Our commercial colleagues proactivity discuss exactly what is on the label with HCPs.  Many organizations will allow their MA field organization to share additional information supportive of the label but it is less common than those that restrict proactivity to the disease state.

In this interpretation of the regulations, MA organizations share additional, supportive information that is not found directly within the label, such as additional studies included in the NDA filing or subsequent studies that are supportive of the label.  It is critical that the science remains within the “confines” of label and merely extends the information supporting that document.

Off-label Proactivity

Clearly this is an unacceptable risk for almost all organizations given the likelihood that it can be interpreted as off-label promotion.

Closing Thoughts

While I don’t think anyone can argue that avoiding proactive discussions about off-label use has been a positive development in terms of risk reduction, the further eroding of the range of acceptable proactivity is definitely more of a mixed bag.  While risk may be reduced, the ability to serve the medical community by educating them on critical information has also been reduced.

And, from an entirely practical point of view, this range of proactivity is confusing as heck for the HCPs we aim to support.  They don’t know that different organizations have different compliance interpretations and risk tolerances – all they know is that some MA staff are more helpful than others.

And, at least we have a range – this is the range of our commercial colleagues:

I would be interested to hear your thoughts – please leave a comment.

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 comment:

  1. [...] 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 world [...]


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