Partner Forum: MLR is Important. What Drives it?

Sorting out competing priorities is one way to expedite medical-legal review. What should drive work flow—great creative for the brand or need to mitigate risk (compliance, legal, medical, regulatory, brand image)?

Michael Golub, MD, FACP
Chief medical officer, Digitas Health LifeBrands
Human consciousness is linear. Accordingly, it is natural to try to prioritize key considerations when analyzing decision-making processes. But for certain complex undertakings, such as pharmaceutical marketing, it is necessary to simultaneously balance many competing priorities. Great creative or regulatory compliance? Yes! Innovative use communications technologies or compliance? Both! Here's why: Pharmaceutical marketing is one of the most tightly regulated forms of communication. Brilliant marketing not thoroughly infused with regulatory awareness is not brilliant. We cannot relegate compliance to a final stage of campaign launch planning. Every step must be informed by the ultimate requirement of regulatory compliance. Otherwise, we are wasting precious time.



Andy Bender
President and founder, Polaris
From a compliance perspective, the process starts with a methodology allowing the company to prioritize risks. This allows the company to focus on the risk reward profile of each risk type that optimizes the value of the company and investment made. The methodology typically consists of elements that define risks. The elements typically fall into different categories, like activity type, audience, value of the activity (dollar amount), process, procedures, past audits, etc. To measure the risk and compare or rank the risks, we assign relative values to each of the elements (1 or low to 5 high), and add these up. Some of the elements can be weighted to have a more prominent representation in the overall risk score. The risk scores allow us to rank or prioritize the activities, and help us determine which are risky.




Angela Tenuta
Executive vice president, Intouch Solutions Chicago
This issue is vast and multifaceted. The sheer variation and volume of projects pouring into the MLR funnel are mind-boggling. Our clients currently use an array of solutions including priority scoring, ROI estimating and mandatory turnaround times. But I would like to propose this is not a priority problem so much as it is a volume problem. And clients can learn from their agencies when it comes to managing volume. Implement annual onboarding and basic work forecasting. Hold regular resource scrum meetings. Demand timelines and estimates for all projects, and stick to them. Deploy talented resource managers and give them the tools and support to do their job. Finally, have a “decider”—the one person who shuts down debating, flags top priorities and kills low priorities.


Steven Michaelson
CEO, calcium, a Star Group company
It's important to consider multiple factors, including which initiatives are expected to drive business growth and which tactics have a critical path to market. In order to be a hot priority, they should rank high on both criteria. Once deemed a priority item, several things can help expedite the process. Mitigating the level of risk is a critical discussion to have at the outset. Time spent up front to communicate early about conceptual ideas pays off in the end by gaining buy-in and discussing “watch-outs” out of the gate. Preplanning several months out and having a long-term calendar view is also helpful and can be adapted as you go.








Victoria Sherriff-Scott
Senior director, editorial services, Klick Health
Managing the flood of materials for MLR review can prove challenging but there are key criteria that can help. Start by prioritizing the materials in the queue, submitting those with the highest business need first, regardless of whether you expect the review process to be straightforward or complicated. If you have multiple pieces that are difficult to prioritize, consider three scenarios: If the pieces are related, submit the anchor piece for MLR review. Feedback on that piece can be then applied to ancillary pieces before they are submitted to reduce the requisite amount of rework. For example, submit the brand website and then reflect the feedback from the MLR team in the associated digital assets before they are submitted. But if the pieces need to launch at the same time and are not necessarily dependent on one another, sequence the submissions so that the pieces that have the longest production time (post-MLR approval) are submitted earliest. For example, be sure that a print brochure (one that will need to go to print and be distributed after MLR approval) or ads (that will need time to be trafficked after MLR approval) are submitted before assets such as a downloadable Doctor Discussion Guide, which can go live shortly after approval. Or, if pieces are not related and the goal is to launch them individually as quickly as possible, sequence the submissions so that those pieces that can be approved quickly are submitted earliest. That way you will be able to launch some pieces while others are being approved. Above all, work closely with your MLR team to help plan and manage the process. Alignment between brand (with assistance from their agency, as needed) and MLR teams is critical for effective collaboration. Advance cloud-based technologies that allow for easy content sharing between stakeholders enable this level of collaboration to streamline the review and approval process across the board. 


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