The brand or commercial department of a life science company tends to perceive the Medical Legal Regulatory (MLR) boards/ promotional review committee (PRC) in general (and often the medical affairs department in particular) as the sheriff, promoting a sort of “us versus them” mentality. This antagonistic relationship can often translate into a silo company in which each department has a difficult time seeing the bigger picture: bringing valuable, safe and effective medications to patients. To combat this, the brand/commercial department can take several steps to build a partnership with the MLR team, which will ideally help resolve disagreements in an amiable manner.
Don’t: Undercut the MLR
It is rather routine to see MLR/PRCs being described as “joy killers,” “sales destruction departments,” etc. These terms are intended to be funny and are not necessarily attributed to individual(s) within a specific department. However, such insinuations detract from the value MLR/PRCs provide and create a dynamic in which MLR either goes “harder” on brands whose teams consistently “attack” them, or goes too easy on them. This is a failure to provide the check and balance necessary to protect the interests of not just the company or its compliance, but also the brand itself.
Feast or Famine
It may, from time to time, be necessary to provide large quantities of promotional items for review simultaneously. This is especially true when a product is being approved for a new indication or a new product itself is being approved. However, to the extent possible, such Brand teams should make a reasonable effort to limit the feast or famine process and provide a steady supply of materials to review. To the extent a promotion is time sensitive, it is perceived that at Brand team has taken more than its fair share of time in the creative process and left insufficient time for the MLR board. Accordingly, the MLR board is expected to try to “make up” for lost time. Nevertheless, companies may find the Brand team complaining that MLR takes “too long”.
MLR teams have complained about this phenomenon and appreciate it when brand teams make an effort to try to spread the work so that the MLR teams can perform appropriate review in a non-rushed manner.
Do: Warn of Large Incoming Volumes When Necessary
Similar to the feast or famine problem, informing an MLR at the last minute that they can expect an onslaught of new promotional materials to review is often found to defeat morale and create an “us versus them” mentality. It would be advisable to provide as much notice as possible if a large set of promotional materials will be sent, allowing MLR members to plan for such an event by bringing in additional help or outsourcing review.
Stratify Based on Urgency and Risk
MLRs routinely receive materials and are informed that the materials require top priority. Unfortunately, there are often competing priorities. It is advantageous to evaluate priorities and determine which materials need top priority or attention and then inform the MLR group of such information. They will not only appreciate your directness, but will also know which materials you need immediately in order to achieve your own goals.
MLR and Brand work for the same “team” and are both eager to help patients. It is important that they both work together to help each other. The previously identified techniques can help with this process. To learn more about best practices to work together, come for my talk at DIA 2016.