Whether you are a life science professional, or a supplier of services to this industry, chances are you have been a part of the excruciating process of PRC or MLR meetings. Promotional review committee or medical legal review, as they are generally referred to, can result in stress, debates, and wasted hours discussing non-critical items.

These meetings occur to ensure compliance with every law and regulation placed on the life science industry. There are two general parties in these meetings; the presenters and the reviewers. Presenters bring in collateral that they would like to use for training or promotion as an example. Reviewers include members of the legal, medical affairs, and regulatory affairs teams. If presenters want their collateral approved for use externally, every reviewer must sign off on it.

On the surface, these meetings sound simple enough, but they are far from it. Presenters have worked many hours on the material they are bringing in. They are hoping for little resistance. But the reviewers are responsible for making sure every claim is in line with the package insert, every medical fact is 100% accurate, and no legal boundaries are being crossed. One wrong word can mean a potential lawsuit, so the stakes are high.

One MLR/PRC meeting may last two hours with an expectation of eight pieces of material being reviewed. If one of these is a sales aid that will go on an iPad or a new website, it is going to be a tedious process.

Let’s pretend the reviewers have started reviewing the first piece. They get through page 1, page 2, and page 3 with no significant issues. The presenter is on cloud nine! Then, BAM – Houston we have a problem.

What’s the problem you may ask? Wait for it…one of the reviewers does not like the font of a particular subtitle on page 4. “It just doesn’t look right”, he says. Reviewer #2 jumps in to agree. The presenter is thinking, “is the font that big of a deal?” But she can’t say that. She needs to develop a long-term partnership with this review committee. True collaboration can only happen if both sides listen to each other. She comments that she can change it to a new font, and they move on.

On page 5, another challenge arises. Reviewer #3 does not like the alignment of the text on this page. Reviewer #1 agrees. The presenter’s heart rate is racing, her face is becoming red, and she is doing everything possible to create agreement. “I will change the alignment,” she whispers.

On page 6, there is a superlative claiming that their product is “the best”. That statement is not acceptable, and understandably, must be changed. Further along in the page, Reviewer #2 has another issue with the font. The presenter is frustrated.

She brings to light that they are only on page 6 of the first item to be reviewed and they are one hour and ten minutes into the meeting. She asks the following questions of the reviewers:

  • Is there anything you have seen that is medically inaccurate?
  • Outside of the claim of being “the best”, is there anything you have seen that is not in line with the package insert and our pivotal studies?
  • Is there any word or statement within this piece that would cause legal trouble for our company?

The answer is NO to all three questions. These are great questions to keep the meeting focused on the task at hand…. But to be fair to the reviewers, although not completely their focus, their opinions do have merit. If they perceive a font or alignment to be “off”, chances are a doctor or sales rep will think the same thing. The last thing a project owner wants is one of their pieces of material to cause distraction because of something as small as spacing.

The reviewers agree to align their efforts on the specific goal of the meeting. The presenter is relieved. Crisis averted.

As she looks up, she notices Reviewer #1 looking uncomfortable and shaking his head. She asks why. He says nothing. After she pries it out of him, he doesn’t like the color of the text. The reviewer is simply trying to help her make her material the best it can possibly be, all with great intentions.

This is the dialogue occurring in the presenter’s mind at this point:

“You have got to be kidding me. I shared this piece with all of them before we even came to this meeting and no one had an issue. Did they even look at it? I am the marketer in the room. I don’t go to their medical conferences and claim to be the expert on molecular structure. You know what they can do? They can SHUT THE FONT UP!”

Everyone who has attended these meetings understands they can get heated. However, creating a collaborative partnership between the presenters and review committee is critical for the company. Everyone is on the same team. Is it worth getting so worked up over a comment about font? Or, can it easily be changed so the meeting can progress?

Like everything in life, it is important to choose your battles. Font, alignment, and text colors aren’t worth it. Getting your product in the hands of that perfect patient is. Let’s start there.