The Forest – A Litmus Test for Every Medical Product Marketer

 Sometimes we look at individual regulatory actions and try and read the tea leaves.  What does it say? What does it mean?  What are the new parameters?

But it also pays to look at the big picture.  This may seem like a statement of the obvious, but it is my impression that we often get so caught up in the trees in our lives, we often forget about the forest (ok, I'm not claiming credit for that…:) ) And certainly in looking at the forest, one can see a convergence of effort on the part of an array of policy makers that is aimed squarely at the nature of pharmaceutical marketing.  

Here is what I'm talking about.  Last week, the Federal Register carried a notice that the Department of Veteran Affairs is proposing to amend its regulations regarding access to VA facilities to control the promotion and sales of medical products.  That is just one of a growing number of efforts that have increased in span and depth to limit the ways that medical products are marketed.  

As a first example, let's look to the most obvious – the FDA.  If you look at the actions of the agency (and warning letters and NOV letters from DDMAC are clearly on the rise) when it comes to marketing, the focus is on making sure that there is fair balance between the positive – the indication and what the medical product can do – and the negative – the risk information. There is also a concerted effort to make sure that one doesn't make unsubstantiated claims, or do anything that positions the product in a way that would influence the user's consideration of it in any way.  In other words, educate about the condition and the availability of a treatment on the basis of the science, but don't sway in other ways.

What about the FTC?  In late 2009, the FTC issued a guideline on endorsements and testimonials. Among other things, it made clear that there must be transparency in relationships between those communicating about products and those manufacturing those products.  And it made clear that with regard to testimonials, a person relating an outcome – that outcome must be supported by evidence.  It cannot represent an experience that some may have, but that most are not likely to have.  

Then let's look at what the states are up to.  States have been proposing and enacting several laws that are aimed at curbing pharmaceutical marketing practices.  The range is broad.  It may involve collecting data and making it available about physicians prescribing patterns, or gifts given to medical practitioners who write scripts or any activity that makes it seem as if – "I'll do this for you, but I hope you'll to that for me" type thing.

And there are members of Congress who have been active on monitoring the level of engagement between medical product manufacturers and medical societies that publish studies and legislation has been introduced to make those connections more transparent.  

There are many more examples.  What is the common thread among all of these (and other) activities?  It is this.  

Any activity that could be perceived by a reasonable person (an increasingly rare commodity) to possibly interfere with a purely clinical decision between doctor and patient by virtue of something other than clinical evidence that is designed to educate, is increasingly the target of regulatory and legal action.  

Clinical data are fine.  Evidence is fine.  Science is good.  But marketing practices that go outside of the statement of data are going to be increasingly scrutinized and possibly the subject of regulatory action.  And so that is the question when looking at any particular marketing activity.  Is this the presentation of objective information to support awareness and decision-making between the physician and patient, or could it be perceived to be an attempt to go beyond the clinical information?  If the former, no problem.  If the latter, you have to ask yourself why, and perhaps look to modify the activity to one that is more educational in nature given the momentum of policy making to limit the ways medical products are marketed.   

As I said in the beginning.  That isn't rocket science.  But clearly there is a concerted effort to shape the nature of medical product promotion to address acts of omission and commission that take the focus on the product away from the science, whether by virtue of a lack of risk information, or a business relationship that is not transparent.  And clearly, the high tide on this issue has not yet been reached.  For those involved in health care communications, a litmus test regarding planned activities can go a long way to regulatory compliance.