So what keeps representatives from having more engaging, more informative, and more credible discussions with physicians? One of the most frequent reasons, or excuses, I hear about is the regulatory constraints placed on representatives. Regulatory restrictions get in the way of being more effective as a sales representative when opportunities for product use exceed the label claims or where representatives could drive more sales by implying or even making comparative claims they can’t support with label claims or “substantial evidence.”
To ensure regulatory compliance, many companies, especially those with Department of Justice Corporate Integrity Agreements, now require representatives to stick to verbatim scripted presentations that mostly do not resonate well with physicians. This “regurgitation of the company message” is an immediate turnoff for physicians, lacks credibility, and makes for awkward representative – physician interactions.
Now, keep in mind the premise of our discussion here. You are a professional representative and your mindset and focus is on making sure patients in your territory are getting the best treatment possible. You are not just “driving sales” by doing and saying whatever it takes to get physicians to prescribe your product as much as possible. Professional representatives don’t need to be reminded of fair balance or to stick to label claims and approved literature, they just do. The challenge for them is whether or not they have the claims and sufficient regulatory compliant data and literature to meet the information needs of their customers.
Some sales representatives might suggest that they have all they need in terms of claims and published data and regulatory is just getting in the way. If that is the case, then why would there be a regulatory compliance issue? Why is regulatory review such a big deal? Why would companies and representatives feel a need to promote off-label to make their sales? Why would companies feel compelled to script boring marketing messages to ensure sales representative compliance? More importantly, why is the market still clamoring for more comparative trials and better data to help them identify best treatment options for patients?
In this competitive market and knowing that products we now have were developed with a “get it to market “ mentality and indication – driven clinical trials to satisfy regulatory requirements for safety and efficacy, I’m going to suggest you do not have the claims or data you need. How many of your products have two well controlled comparative efficacy trials to support claims of differentiation that you can use in sales presentations? Can you claim superiority? If not, how can you discuss why your product is better than another for a particular patient type? Can you do this and be compliant with regulatory requirements or are you expected to just cleverly implying a difference?
Here is the problem. Even today, research gets the indications and it is up to marketing and sales to differentiate the product in the market. When a physician or managed plan decision-maker asks why they should use your product rather than a competitive product, how do you answer? Blatant claims of superiority or implied differentiation are the only way to convince them why your product should be used over another product.
What’s interesting is that when research and management talk about products to investors or in company presentations, especially before launch, they talk about and always answer questions about how the product is better than anything else out there, often using historical data from competitive products compared to their just released clinical data. They highlight all the wonderful features and benefits that your product has over the competition, even quote data that imply superiority.
But, when marketing and sales wants to take those same messages to the market they have this regulatory issue. While the research and management statements may be true, they don’t necessarily come with the label claims or “substantial evidence” to support those same claims in advertising and promotion. Yet, revenue forecasts are driven off those claims and expectations for differentiation. And besides, who ever launched a product that wasn’t considered by their research team and management to be better than anything out there?
Pharmaceutical companies can no longer expect, pharmaceutical representatives to fill the label claim and “substantial evidence” data void for products. The disconnect between product differentiation assumptions used for revenue forecasts and the regulatory constrained messaging puts the representative in an unfair position of having to deliver sales expectations beyond that which would be or ever could be achievable given a compliant presentation.
To be effective, even professional representatives need regulatory compliant information, comprehensive label claims, and more importantly, “substantial evidence” documented in peer-reviewed published literature. This is the responsibility of management and the research team. It is then marketing’s responsibility to develop forecasts that are aligned with the label claims and regulatory compliant information available for presentations and discussions by representatives. mike@pharmareform.com