PM360 March 2010

COMPLIANCE CENTER

KEEPING YOUR CUSTOMER TARGETING SAFE
By RICHARD S. LEV, JD

With OIG investigations into off-label marketing practices continuing and pharmaceutical compliance programs ever expanding in scope, one area in particular has recently received a great deal of scrutiny: customer targeting. The OIG has long considered pharmaceutical detailing and sampling efforts directed to physician specialties that are off-label for a particular product as evidence of intent in criminal cases. For example, a sales representative detailing a pediatrician on a product that is not approved for use in children is problematic from a compliance perspective, even if the provided detail is strictly for an on-label use.

With each new Corporate Integrity Agreement (CIA) that emerges, we see greater controls being put into place to prevent and detect off-label detailing and product sampling. In many pharmaceutical companies, this process now begins with creation of the Target Call List (TCL). To ensure appropriate targeting and sampling, all marketed brands should be evaluated, at least annually, as to physician specialty areas and drug utilization. Any specialty or practice areas where off-label usage may be predominant should be considered for exclusion by the field force for that brand.

Specialty Screening
TCLs must then be aligned with the approved drug label and the field force given clear guidance and training regarding appropriate customers who can or cannot be detailed or sampled for a given drug brand. Be prepared, however, for challenges in the execution of such policies. For example, sales representatives may be carrying several brands across multiple specialties, which can lead to confusion and errors. In addition, physician specialties may be listed one way on the TCL, but the shingle outside their office or their business card indicates differently. Changes or additions to TCLs can always be made but should require prior approval by sales and marketing leadership with appropriate input from legal/compliance.

Establishing the list of approved and excluded specialties for a brand is only part of the battle, however. A robust compliance program also requires that policies and procedures be put in place to ensure that deviations can be detected and corrected. If a sales representative were to deliver a detail or sample a physician in an excluded specialty, whether inadvertently or otherwise, would it trigger any red flags within your organization? This is not just strictly a compliance issue because at the end of the day you want your field force to be on message and calling on the right audience too.

Automate Compliance
One way to avoid operational difficulties and enhance compliance efforts is to try to automate the process as much as possible. For example, if your field force uses a Sales Force Automation (SFA) system, can it be configured to automatically lock out detailing or sampling of excluded specialties? Many pharmaceutical companies that are under a CIA have already modified their SFA systems in this way. Similarly, depending on how your sample accountability system is configured, you should be able to create an automatic alert
system whenever a product is sampled to an excluded specialty. These approaches allow for a rapid response to potential compliance issues and for fine-tuning the TCL in real time.

Richard S. Lev is the Chief Compliance Officer at Publicis Strategic Solutions Group in Somerset, NJ. He
can be reached at richard.lev@psellingsolutions.com