Improve your medical-legal reviews with better preparation.

This week, we were able to delve into an enlightening conversation with subject matter expert Lisa Sherwood. With her extensive knowledge and experience in pharmaceutical marketing, Lisa shares invaluable insights into the intricacies of medical-legal reviews, the importance of preparation, and the art of effective communication in marketing. 

In this blog post, we outline the questions posed to Lisa and her thoughtful responses (lightly edited for clarity and brevity), providing a comprehensive guide for anyone navigating this complex process.

How should marketing teams prepare for an efficient and successful medical-legal review?

The success of a medical-legal review largely hinges on the preparation that is undertaken before the actual review meeting. Here are some steps that are helpful:

• Medical Research: Thoroughly comprehending your product is crucial. Equally important is understanding your target audience—their lifestyle, motivations for seeking treatment, and preferences. This information will inform both your brand and communication strategy, helping you connect with your audience emotionally and incite them to act.
  
• Identify Audience Needs: The communication strategy determines how to state the unmet needs in a way that is compelling. Once that is determined, it is time to collaborate with the agency and create the creative brief. The brief should outline your piece's intent, messaging, and tone and include scientific data that supports your communication strategy and distinguishes your product from competitors.
  
• Review Content: After the content is developed by the agency, it is imperative to ensure your communication is medically accurate. This step, often neglected, can be a primary reason for rejection during the MLR process. Annotated references are essential for ensuring clarity and effective messaging. It's crucial to accurately cite all sources and effectively translate scientific information into marketing messages without misrepresentation.
  
• Medical-Legal Review: Once everything is in place, the medical-legal review process begins. You must be prepared to discuss your resources and explain the importance of your messages. If the legal department finds a message unacceptable, you need to collaborate with them to revise it. Understanding why each message is important will assist in this process, rather than simply deleting it.

Don't forget to be open to making small changes to make a statement acceptable. For example, changing one word can often shift a statement from being exaggerated to being acceptable. Attorneys interpret things differently, so it's important to think from their perspective as well.

The ideal MLR would be a job without changes (or with minor changes that can be made on the spot) that is approved for production. Meaning, the medical-legal review team does not need to see it again. You can make the minor tweaks and changes and proceed to editorial certification and distribution.

The middle of the road is medical-legal review making changes or suggesting changes that they would like to review again. Perhaps their changes move things around, and they want to see how the placement will look, or they give you the essence of what they want, and you have to go back to the agency to figure out how to craft the message, or there are so many minor changes that they want one last review. 

Worst-case scenario, the deliverable is rejected. That is typically done when the statements made in the resource are not supported by the references provided, the reference provided is not credible, or you are making claims that are not medically accurate. 

What are some of the common pitfalls of the MLR process?

Creating an accurate creative brief

The kickoff meeting with the agency is crucial in the MLR process. It helps to align everyone's understanding and expectations. We start by writing a creative brief, which some might find time-consuming, but it's an essential step that gets everyone on the same page. This requires going back and forth until everyone is aligned.

When it comes to our product's lifecycle, the stage it's in has a big impact on the process. When we're launching a brand new product, we really push the boundaries with our messaging. However, we always keep in mind that the medical-legal review team has the final say and can make changes. The goal is to get the best messaging right from the start. This way, we can build a solid foundation and avoid having to make changes later on. Typically, when a product is launched, our team creates a sales aid for reps to use with healthcare professionals, as well as a journal ad. Once we have those pieces, everything else falls into place.

Content knowledge

Understanding our audience through market research is vital. It influences not just what we say, but how we say it. For instance, portraying patients as too happy might be inappropriate for certain diseases. Overselling the medication's benefits through imagery can also lead to overpromising, which is a concern.

During the actual review, knowing your piece and being ready to negotiate and collaborate is key. I recall an instance where I was reviewing an email for another department. The reviewers questioned why a certain phrase was used. I wasn't immediately aware of the reason, but another colleague clarified that it was common language used by this target audience. This language was integral to reaching the customer effectively, and since I wasn't on the team, I was unaware of its meaning and would have removed it without fully understanding the purpose. Understanding the context and importance of every element in your piece is crucial. Removing something without fully grasping its purpose can lead to missed opportunities for effectively communicating with our audience.

Go in prepared

Prepare for the meeting by reviewing the comments in the file and being ready to answer them on the spot. This will help your review go smoothly. The file will be in a repository for several days for review before the meeting. Check the comments a day or two before so the bulk of the comments are in. Depending on the type of content, determine how much time you will need. For something like a one-page document, it may only take 10-15 minutes to review. For a video script, allow at least 30 minutes. During the live meeting, you can receive feedback and make quick changes on the spot to get approval. Alternatively, you may need to listen to all the feedback, make the changes, and resubmit the file. If this is the outcome, you will likely have to update the creative brief, have your agency edit the content, and then resubmit, with another several days in the repository. So if you need corrections, it may take two weeks or two months.  Aim for that first-round approval to remain efficient. 

What does the relationship with the MLR team look like in your experience? How do you develop a strong relationship with the team?

It's all about communication and understanding their preferences. One key thing is to avoid asking for too many exceptions or going outside the normal process. They typically don't have the bandwidth to review something in less than five days or outside of the scheduled review. So it's important to be prepared and meet deadlines.

Another important factor is tone and attitude. I recall when a new attorney joined our team and she was reviewing an email.  This was scheduled for a 15 minute review and she needed about 45 minutes for more of the historical perspective as to why we create this resource and to thoroughly review it.  Recognizing this, I stepped in to reassure her that I was aware of her high standards and aimed to respect her time as well as that of everyone else involved. I proposed to address the issue and revisit it with her later. She appreciated this proactive approach and conceded that it can sometimes be challenging to witness all the changes being made. From then on, I made it a point to follow her preferred method of reviewing and implementing edits, thereby promoting a positive working relationship.

Building credibility with each team member is also crucial. Every person on the team has their own preferences and ways of doing things. Once you know what they like to see or how they operate, it becomes much easier to work with them. Some team members may go through every attachment and linked job meticulously, while others may trust your work. It's all about proving yourself trustworthy and reliable.

Ultimately, the goal is to gain their trust and confidence in your ability to make changes without needing another round of review unless truly necessary. Building a strong relationship with the MLR team takes time, but it's worth it in the long run.

What is one piece of advice that can make the difference between success and failure in the MLR?

The key advice is simple: preparation. It's all about being thoroughly prepared in every aspect—from materials to understanding the purpose behind your communication. Don't forget to pay attention to the details, too, because they matter. Without a solid understanding of why you're writing or communicating, you risk losing the trust and credibility of the medical team. They need to understand the message and see its value. And preparation isn't just about checking boxes; it's about finding workable solutions and negotiating with all parties involved. So, it's crucial to know why you're communicating, then cross your t's and dot your i's, and enter the review process ready to share your knowledge and collaborate effectively. This strategic approach is what sets successful marketers apart in the MLR.

If you are able to demonstrate to the MLR team that you have done your homework and that your marketing materials are accurate and truthful, you will be well on your way to getting your materials approved.