Medical Affairs Focus

Thoughts on Global Medical Affairs

Topic1: Proactivity- Impact of Decreased Proactivity

Given the ambiguity of the regulations, most organizations are reducing the degree of proactivity to ensure that they remain within compliance.  Going to the left on the MA Spectrum of Proactivity.   However, decreasing the degree of proactivity carries risks of its own.

Failing to Meet Obligations as Partners in Science

The most pressing risk associated with limiting the proactivity of MA outreach is that information that would have been useful to the HCPs does not get into their hands.  While HCPs have the obligation to maintain their own knowledge, the reality is that there is so much information available that many HCPs cannot possibly keep up with everything, especially physicians that treat a range of disease states.  They rely on many expert groups, including associations, practice standard setting bodies, journals and, yes, pharmaceutical companies to help point out information they may not have found on their own.  Pharma companies often employ some of the leading experts on the disease state where they focus their research and have a positive perspective to share with the community.

Confusion Among HCPs

Given that many HCPs have traditionally relied on pharma as one of their sources for alerting them to new scientific information, the sudden halting of this support would normally be disruptive.  But, even more challenging is the fact that this change will be unclear to the HCPs as different pharma companies set different policies.   A pharma company that recently reduced its degree of proactivity surveyed some HCPs it would have normally interacted, and found a strong sense of betrayal by those HCPs that the organization had discontinued this support and an equally strong sense of confusion about why this support would be discontinued.   Most HCPs surveyed said they would not replace proactive interaction with direct contact to the pharma companies because, to paraphrase one response, they don’t know what they don’t know to ask about.

Closing Thoughts

Every company needs to weigh risk and benefits with any decision it makes.  Unfortunately, when it comes to proactivity many organizations have lately been focused entirely on risk.  Even with the ambiguity noted in a previous post there appears to be room for some form of proactivity.  And, HCPs are expecting it.  For MA to achieve their goals, they need to work with their organizations to ensure that the benefit/risk is being considered in full before any changes are made.

What do you think?  Leave a comment below.

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.

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One response to “Topic1: Proactivity- Impact of Decreased Proactivity

  1. Pingback: Topic19: MA Impact of the Caronia Ruling « Medical Affairs Focus

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