As a current and former speaker for a number of companies on a variety of products, I recognize the challenges that pharmaceutical marketers have in effectively communicating important information to physicians and other prescribers under the confines of today’s strict regulatory environment. I have been told of heated internal battles between marketing and compliance in generating promotional material.

As a physician, I always appreciate the opportunity to criticize lawyers, but in this case their conservative approach is understandable given previous exorbitant settlements for off-label promotion.

However, the result of this ultra-conservative approach taken by the compliance offices of almost every pharma company is that most promotional material meant for physicians is simply a re-statement of the package insert (PI). This is not only true for advertisements and detail aids, but also for speaker programs and online promotional presentations—the latter of which seem to be increasing as representative access to physicians steadily decline.

The Limits of Drug Information

The problem is that the information in the PI is extremely limited and therefore not incredibly useful to the practicing physician. With ubiquitous online access and mobile applications like Epocrates, if a physician needs to know the dose, indication or interactions of a specific medicine she simply looks it up. Thus, the pharmaceutical company is providing very limited to no value if the only information they can communicate with physicians is strictly limited to the PI.

To be clear, I am not asking for the industry to promote a product outside its label. I think it is very reasonable that current law limits sales representatives from promoting off-label indications. However, just because accepted published scientific information is not in the PI, does not (at least from my perspective), mean that it is off-label. I am specifically referring to disease state information. In addition to epidemiology and pathophysiology, where a particular pharmaceutical product fits within the spectrum of treatment in a given disease state is critical information for providers of care.

This is particularly important when it comes to a new therapeutic class, as practicing physicians likely did not learn about these things during their medical training. It is for this reason that many physicians value information from pharmaceutical companies, and why disease state information used to be a key and critical component of most promotional campaigns. However, today discussing disease state is relatively rare—and when present—extremely limited.

As previous large settlements did not stem from companies talking about disease state information, and strict policies to prevent off-label promotion are now in place in every company, pharmaceutical companies need to start liberalizing their policies when it comes to using disease state information with their promotional marketing to physicians. Three areas to focus on should include epidemiology, basic pathophysiology and practice guidelines. A multitude of guidelines are always changing, making it virtually impossible for the practicing clinician to keep up. Communicating guidelines—and how a particular product fits into those guidelines—was once a staple of pharmaceutical promotion, but is now almost non-existent.  To increase the value that pharmaceutical marketers can bring to physicians, it’s time to go beyond the PI.

  • Matthew Mintz, M.D.

    Matthew Mintz, MD, FACP, is Associate Professor of Medicine and Director, Premier Access and Executive Services at The George Washington University School of Medicine in Washington, DC. Visit his blog at


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